[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute on Drug Abuse (NIDA)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":517},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,47,74,97,115,139,159,179,191,201,211,221,231,241,265,289,313,339,361,384,410,437,459,479,491],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053321","early-phase-1-developing-transcranial-neuromodulation-protocols-for-learning-and-decision-making-100053321",false,"NCT06561828","Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n* Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.\n* In good general health based on the assessment of the MAI.\n* Right-handed.\n\nEXCLUSION CRITERIA:\n\nIndividuals who meet any of the following criteria will be excluded from participation:\n\n* Any neurological disorder that would increase seizure risk from TMS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.\n* Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).\n* Current use (any use in the past two weeks, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), anti or pro-convulsive action. This will be determined at the discretion of the MAI.\n* Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.\n* History of noise-induced hearing loss or tinnitus.\n* Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.\n* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n* Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.\n* Participation in any neuromodulation (e.g., TMS, tFUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.\n* For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the protocol itself.\n* Uncorrected impairments in visual acuity severe enough to affect task participation.\n* Non-English speaking. Justification: Data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TMS and MRI procedures. The inability to effectively communicate TMS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Pregnancy. Justification: It is unknown whether MRI and TMS pose risks to fetuses.\n* Any other condition that in the judgment of the investigators is incompatible with participation.","ALL","18 Years","45 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Background:\n\nPeople with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to know how a technique called transcranial magnetic stimulation (TMS) may cause changes in brain activity that may help people with SUD.\n\nObjective:\n\nTo test TMS in healthy volunteers.\n\nEligibility:\n\nHealthy people aged 18 to 45 years who are right-handed.\n\nDesign:\n\nParticipants can volunteer for up to 5 different experiments. Each experiment requires 2 to 8 clinic visits. Each visit will last 3 to 7 hours.\n\nSome visits will include TMS. A coil will be placed on the participant s head. A brief electrical current will pass through the coil to create a magnetic field. Participants may feel a tapping or pulling sensation on the skin under the coil. They may feel a twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense certain muscles during TMS.\n\nSome visits will include functional magnetic resonance imaging (fMRI) scans. Participants will lie on a bed that slides into a large tube. They will perform tasks on a computer inside the tube. The fMRI will show which parts of the brain are used during each task.\n\nParticipants will perform tasks on a computer. Some tasks may be done at a desk as well as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors, or taste flavored liquids. Their vital signs may be monitored and their eye movements may be tracked during tasks.",[27],"Normal Physiology",[29,30,31,32,33],"TMS","Decision Making","fMRI","Learning","Behavioral Tasks","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":21},"2026-07-16",{"date":42,"type":21},"2044-11-02",{"name":44,"class":45},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100053725","phase-1-phase-i-trial-of-high-density-theta-burst-stimulation-hdtbs-100053725","NCT06868914","Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)","Phase I Clinical Trial to Study the Safety and After-effects of Transcranial Magnetic Stimulation (TMS) Using A High-density Theta Burst Stimulation (hdTBS) Paradigm","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Be 22-60 years of age.\n\n  --Justification: Many neural processes change with age, and these changes could introduce unwanted variability in behavior. In addition, the risk of difficult-to detect medical abnormalities such as silent cerebral infarcts increase with age. Children under the age of 22 are excluded from this study because safety of rTMS in children has not been studied. In addition, this study is more than minimal risk and presents no direct benefit.\n* Ability and willingness to provide written informed consent.\n\n  --Justification: Written informed consent must be obtained for this study per NIH policy and federal regulations.\n* Generally in good health.\n\n  * Justification: Many illnesses may alter neural functioning. These will be evaluated by the MAI and excluded as needed.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days or other neurological condition deemed by the MAI to be likely to affect response to the TBS being delivered.\n\n* Justification: Stroke or head trauma can lower the seizure threshold, and are therefore contra indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures.\n\n  -First-degree family history of any form of epilepsy with a potentially hereditary basis.\n* Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.\n\n  -Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes TMS intervention.\n* Justification: Any metal around the head is a contraindication for TMS, as it involves exposure to a relatively strong magnetic field.\n\n  -Noise-induced hearing loss or tinnitus.\n* Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS equipment.\n\n  -Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action.\n* Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.\n\n  -Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.\n* Justification: The population of interest here is a healthy control population with no psychiatric disorders. In participants with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms.\n\n  -Current use of nicotine (self-report, urine cotinine test and\u002F or CO consistent with smoker) or history of more than 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.\n* Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required.\n\n  -Current regular use of more than 2 cups of coffee or equivalent caffeine intake in the morning (not total daily intake).\n* Justification: Excessive caffeine use can reduce seizure threshold and could potentially increase risk of TMS-induced seizure.\n\n  -Meet current DSM-5 criteria for any substance use disorder, or urine toxicology positive for any illicit substance inconsistent with history given.\n* Justification: The population of interest is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS.\n\n  -Have met DSM-5 criteria for any substance use disorder in the past.\n* Justification: the population of interest is a healthy control population with no present or past substance use disorder.\n\n  -History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.\n* Justifications: the risk of TMS for individuals with a heart condition is unknown.\n\n  -Pregnant individuals or individuals with reproductive potential who are sexually active and do not report using contraception.\n* Justification: it is unknown whether TMS poses a risk to fetuses.\n\n  -Otherwise TMS incompatible or have participated in any noninvasive brain stimulation (NIBS) session in the past two weeks or a NIBS treatment course in the past 6 months.\n* Justification: in order to limit exposure to TMS, we will not enroll participants who have received TMS less than two weeks ago.","22 Years","60 Years",{"count":57,"type":21},35,[59],"PHASE1","Background:\n\nTranscranial magnetic stimulation (TMS) uses magnetic pulses to affect brain activity. A type of TMS called theta burst stimulation (TBS) is approved to treat people with major depression. Researchers have developed a new form of TBS called high-density TBS (hdTBS). They hope hdTBS will work better than TBS. But first they need to test the new treatment in healthy adults.\n\nObjective:\n\nTo test hdTBS in healthy adults. Also, to compare the aftereffects of hdTBS and TBS.\n\nEligibility:\n\nHealthy adults aged 22 to 60 years.\n\nDesign:\n\nParticipants will have 4 clinic visits over about 3 to 4 weeks. They must abstain from drugs and alcohol and limit caffeine before visits.\n\nAt their first visit, participants will be oriented to TBS. They will wear a cap and earplugs. A device with round coils will be placed near their head. When a brief electric current passes through the coil, it generates a magnetic pulse that stimulates the brain. Participants may feel a pulling sensation on the skin under the coil. Their fingers may move involuntarily.\n\nAt their next 3 visits, participants will receive either TBS or sham TBS. A sham TBS uses a low magnetic field to minimize the effects of the treatment. Participants will have up to 9 electrodes placed on 1 arm. These electrodes will measure the electrical activity in their muscles. Each TBS session will be videotaped.\n\nAt every visit, participants will answer questions about their health, including substance use. They will perform 2 tasks to test their thinking skills. They will perform a test on a computer to test their reaction time....",[62],"Healthy Volunteers",[64,65,66,67],"Substance Use Disorders (SUDs)","Transcranial Magnetic Stimulation (TMS)","Theta Burst Stimulation (TBS)","High-density Theta Burst Stimulation (hdTBS)","NOT_YET_RECRUITING",{"date":37,"type":38},{"date":40,"type":21},{"date":72,"type":21},"2028-01-13",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100053883","smart-r-substance-monitoring-and-active-relapse-tracking-repository-100053883","NCT06676059","SMART-r: Substance Monitoring and Active Relapse Tracking Repository","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in the repository, an individual must meet all of the following criteria:\n\n* Must understand and be willing to complete an online informed consent process.\n* Be an adult aged 18 or older.\n* Self-report alcohol or other drug use within the past 30 days.\n* Have a smartphone as their primary mobile phone.\n\n  --For the AWARE app data monitoring procedure, there may be times during this study period where, due to technical or OS limitations, the app is only available to users of certain devices (e.g., Android, iOS). If there is such a limitation, this information will be evaluated during screening. For example, if the AWARE app is not available for iOS, then the screening form may exclude iPhone users for that time period where the limitation exists, if the only procedures offered are daily diary surveys and AWARE data monitoring.\n* Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, open-ended survey questions with the TTR Chatbot, uploading historical conversational AI data, and\u002For follow-up surveys.\n* Understand and write in English.\n\n  --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.\n* Live in the United States.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this repository:\n\n1\\. Any impairment severe enough to preclude informed consent or valid self-report.","120 Years",{"count":82,"type":21},10000,"OBSERVATIONAL","Background:\n\nAbout 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program. For those who start treatment, about 70% return to substance use within weeks or months after starting treatment. To discover why patients drop out of treatment and return to substance use - and what can be done about it - researchers need to learn more about people who use drugs and alcohol.\n\nObjective:\n\nTo create a data repository by gathering survey and smartphone data from adults who use drugs and alcohol in order to conduct future research.\n\nEligibility:\n\nAdults who have used drugs or alcohol in the past and have a Android smartphone. The researchers will recruit targeted demographics at different times throughout the duration of the study period.\n\nDesign:\n\nData will be collected for up to 6 months. All research activities will be online.\n\nParticipants will download a smartphone app called TTRU-Curtis AWARE and keep it active on their phone. The app will run in the background and collect participant data, including: screen unlocks, duration of time the screen is on; apps used; words typed (except passwords); duration and time of phone calls; estimated location (exact location is not collected); and movement, such as how many steps are taken in a day. All personally identifying information is automatically removed before the data is stored (including phone numbers, names, or locations described in messages).\n\nEach day, participants will receive a text with a link to a survey. They will answer questions about their mood, behavior, and substance use from the day before. This survey should take less than 5 minutes to complete.\n\nEvery 30 days, participants will complete a longer survey. They will answer questions about their personal relationships, risky behaviors, mood, substance use, and feelings. They can skip any questions they do not feel comfortable answering. These surveys should take about 30 minutes to complete.\n\nParticipants may opt to allow researchers to access their social media posts.",[86,87],"Alcoholism","Substance-Related Disorders",[89,90,91],"Alcohol","Substance use","digital phenotyping",{"date":37,"type":38},{"date":40,"type":21},{"date":95,"type":21},"2044-12-31",{"name":44,"class":45},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},"100054100","early-phase-1-causal-mechanisms-of-odor-guided-behavior-in-humans-100054100","NCT07099092","Causal Mechanisms of Odor-Guided Behavior in Humans","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Willingness to comply with all study procedures and availability for the duration of the study.\n2. Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.\n3. In good general health based on the assessment of the Medical Advisory Investigator (MAI).\n4. Agreement to adhere to Lifestyle Considerations throughout study duration. Consent signature will be documentation of meeting this criterion.\n5. Right-handed.\n\nEXCLUSION CRITERIA\n\nIndividuals who meet any of the following criteria will be excluded from participation:\n\n1. Any neurological disorder that would increase seizure risk from TUS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.\n2. Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).\n3. Current use (any use in the past week, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), or anti or pro-convulsive action. This will be determined at the discretion of the MAI.\n4. Unable to undergo MRI, or TUS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.\n5. History of noise-induced hearing loss or tinnitus.\n6. Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessivecompulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.\n7. Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n8. Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.\n9. Participation in any neuromodulation (e.g., TMS, TUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.\n10. History of anaphylaxis, e.g., due to severe asthma, and\u002For food and non-food allergies (e.g., latex, detergents, soap, etc.).\n11. History of significant chronic obstructive pulmonary disease (COPD) as increased levels of carbon dioxide may increase the susceptibility to cavitation and related tissue damage.\n12. Uncorrected impairments in visual acuity severe enough to affect task participation.\n13. Non-English speaking. Justification: Data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TUS and MRI procedures. The inability to effectively communicate TUS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n14. Serious skin disease or serious skin allergy on the hands or head. Justification: Gel will be applied to the skin on both head and hands, for transducer coupling and electrode placement, respectively. Allergic or adverse reactions to such treatment need to be ruled out.\n15. Hyposmia, i.e., decreased sense of smell, or anosmia, i.e., loss of smell (Sniffin' Sticks Olfactory Identification Score \\\u003C 10). Justification: The ability to smell is paramount to task performance.\n16. Pregnancy. Justification: It is unknown whether MRI and pose risks to fetuses.\n17. Any other condition that in the judgment of the investigators is incompatible with participation.",{"count":104,"type":21},80,[24],"Background:\n\nLittle is known about how different regions of the brain responsible for the human sense of smell guide behaviors. In this study, researchers use a technique called transcranial ultrasound stimulation (TUS) to learn how odors affect the brain and behavior.\n\nObjective:\n\nTo learn more about how the human sense of smell works.\n\nEligibility:\n\nHealthy people aged 18 to 45 years who are right-handed.\n\nDesign:\n\nParticipants can volunteer for up to 2 different experiments. Each experiment requires 5 visits, each about 1 week apart. Food, alcohol, and caffeine may be limited before visits.\n\nAt the start of each visit, participants will answer questions about their health and how well they slept. Their sense of smell will be assessed.\n\nSome visits may include tasks on a computer: While doing these tasks, participants may be asked to smell different odors, look at pictures, and listen to sounds. They will wear devices to track breathing, blood pressure, pulse, and other body responses to the tasks.\n\nSome visits may include TUS: TUS uses ultrasound waves to briefly change brain activity. A gel will be applied to the scalp and hair, and a device will be placed against the participant s head. Participants may feel a tapping, pulling, and\u002For warm sensation on the skin underneath the device. They may also feel a twitch in their face, neck, arm, or leg muscles. Participants will do tasks before and after TUS.\n\nSome visits will include functional magnetic resonance imaging (fMRI) scans. fMRI uses magnet and radio waves to capture images of the activity inside the brain. Participants will lie on a table that slides into a tube. They will perform tasks inside the scanner.",[27],[33,30,31,109],"TUS",{"date":37,"type":38},{"date":40,"type":21},{"date":113,"type":21},"2035-07-14",{"name":44,"class":45},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":46},"100053792","orexin-s-role-in-the-neurobiology-of-substance-use-disorder-100053792","NCT05630781","Orexin s Role in the Neurobiology of Substance Use Disorder","Orexin's Role in The Neurobiology of Substance Use Disorder","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants\n\n* Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n* Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent.\n\nNicotine Dependence Arm\n\n-Participants must smoke\u002Fvape a minimum of 4 times per week with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng\u002Fml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll Participants\n\n* Participants cannot meet DSM-5 criteria for lifetime and\u002For current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.\n* Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.\n* Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.\n* Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary.\n* Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.\n* Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics.\n* Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant.\n* Individuals with severe hepatic impairment will be excluded\n* Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35.\n* Participants cannot be using a strong CYP3A inhibitor\u002Finducer (metabolism by CYP3A is the major elimination pathway for suvorexant)\n* Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome, ischemic heart disease, or uncontrolled hypertension.\n* Participants cannot have narcolepsy.\n* Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls.\n* Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months.\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n* Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Contraindication to MRI as determined by MRI Safety Screening form.\n\nNicotine Dependent Arm\n\n* Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.\n* Participants cannot meet DSM-5 criteria for moderate or severe ADHD.\n\nControl Arm\n\n* May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm.\n* Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and\u002For designee.\n* Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n* May not have (or currently be treated\u002Fmedicated for) any diagnoses\u002Fconditions contraindicated for use of methylphenidate.\n* Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.",true,{"count":124,"type":21},140,[126],"NA","Study Description:\n\nDespite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals.\n\nObjectives:\n\nThe objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm.\n\nEndpoints:\n\nIn nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward\u002Fcognition as well as impacts the pharmacological influence of methylphenidate on those same measures.\n\nStudy Population:\\\u003CTAB\\>\n\nNicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers\u002Fvapers.\n\nControl arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers\u002Fvapers\n\nThis study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD.\n\nDescription of Study Intervention:\n\nNicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days.\n\nControl arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)\n\nStudy Duration:\n\n5 years\n\nParticipant Duration:\n\n1-2 months",[129],"Nicotine Dependence",[131,31,132,129],"Orexin Antagonish","Substance Use Disorder",{"date":37,"type":38},{"date":135,"type":38},"2023-02-15",{"date":137,"type":21},"2027-12-31",{"name":44,"class":45},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100053999","olfactory-function-and-model-based-behavior-in-people-living-with-hiv-and-sud-100053999","NCT07637669","Olfactory Function and Model-Based Behavior in People Living With HIV and SUD","Olfactory Function and Model-based Behavior in People Living With HIV and SUD","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nFor all participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nFor participants in the HIV+ and SUD+ and HIV+ and SUD- groups:\n\n-HIV positive.\n\nFor participants in the HIV+ and SUD+ and HIV- \\& SUD+ groups:\n\n-Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all participants:\n\n* History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.\n* History of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD.\n* Candidates who recently (12 hours prior to a study visit) used medications and\u002For substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI\u002FPI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.\n* History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.\n* Uncorrected impairments in visual acuity.\n* Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.\n* Pregnancy.\n* Any other condition that in the judgment of the investigators is incompatible with participation.\n\nFor participants in the HIV+ and SUD- and HIV- and SUD- groups:\n\n* History of current (past 12 months) SUD, excluding tobacco use disorder.\n* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n* Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.\n\nFor participants in the HIV- and SU+ and HIV- and SUD- groups:\n\n-HIV positive.\n\nFor the Optional MRI Segment:\n\n-Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.","65 Years",{"count":148,"type":21},120,"Background:\n\nHuman immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.\n\nObjective:\n\nTo test the sense of smell in people with HIV and\u002For SUD and how they make choices based on odors.\n\nEligibility:\n\nPeople aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.\n\nDesign:\n\nParticipants will have 2 visits. Each visit will last 3 to 5 hours.\n\nIn visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:\n\nThey will smell scented sticks and answer questions about them. They will be blindfolded for some tests.\n\nThey will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.\n\nIn visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.",[151,132],"HIV",[151,132,153,30],"Olfaction",{"date":37,"type":38},{"date":40,"type":21},{"date":157,"type":21},"2031-06-27",{"name":44,"class":45},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":122,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":46},"100054050","phase-1-environment-and-alcohol-a-pilot-study-100054050","NCT06860607","Environment and Alcohol: A Pilot Study","* INCLUSION CRITERIA:\n\nTo meet eligibility for this study, participants must meet all the following criteria:\n\n1. At least 21 years old\n2. Owns a cellular device (\"smart phone\") and is willing to download the EMA application and use it to answer the study questionnaires\n3. Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n4. Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \\> 7 drinks per week for females or \\> 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with \\> 3 drinks for females or \\> 4 drinks for males during the 28-day period prior to screening\n5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\\u003C 10\n6. If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.\n\nEXCLUSION CRITERIA:\n\nAny individual who meets any of the following criteria will be excluded from this study:\n\n1. Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD\n2. Medical and\u002For mental health conditions that are clinically unstable and would therefore compromise the safety and\u002For scientific integrity of the study, as determined by the MAI or study team respectively.\n3. Known history of clinically significant cybersickness.\n4. Any other reason or clinical condition that the Investigators judge would interfere with study participation and\u002For be unsafe for a participant\n5. Unable to speak, read, write, and understand English\n\nJustification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study.","21 Years","100 Years",{"count":168,"type":21},44,[59],"Background:\n\nAlcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes.\n\nObjective:\n\nTo evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD.\n\nDesign:\n\nParticipants will have up to 10 study visits in Baltimore.\n\nParticipants will have a baseline visit. They will have a physical exam with blood and urine tests. They will have a breath test for alcohol and a test that measures body composition. They will answer questions about their alcohol and substance use; mental and physical health; mood and anxiety; and sleep quality.\n\nParticipants will download an app called MetricWire. The app will send 3 sets of questions to be answered at different times throughout the day.\n\nThe study visits will include 2 stages:\n\n1. Active stage. On these visits, participants will use a virtual reality system called the Meta Quest Pro (MQP) as they choose. Then they may choose among video games, puzzles, books, crafts, and other activities.. These sessions will last for 3 hours.\n2. Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.\n\nOn the last visit of each stage, participants will sit in a room that looks like a bar. They will answer questions about their cravings, their urge to drink, and how many drinks they would buy. Participants will be served 1 drink containing alcohol. They will be asked about their cravings and subjective effects of alcohol after drinking it.",[172],"Alcohol Use Disorder",[172],{"date":37,"type":38},{"date":40,"type":21},{"date":177,"type":21},"2028-03-01",{"name":44,"class":45},{"id":180,"slug":4,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":181,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":149,"conditions":182,"keywords":183,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":46},"100641768",{"count":148,"type":21},[151,132],[151,132,153,30],"2026-07-01",{"date":186,"type":38},"2026-07-02",{"date":188,"type":21},"2026-07-07",{"date":157,"type":21},{"name":44,"class":45},{"id":192,"slug":4,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":106,"conditions":195,"keywords":196,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":200,"locationsCount":46},"100600561",{"count":104,"type":21},[24],[27],[33,30,31,109],{"date":186,"type":38},{"date":188,"type":21},{"date":113,"type":21},{"name":44,"class":45},{"id":202,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":60,"conditions":205,"keywords":206,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":210,"locationsCount":46},"100582869",{"count":57,"type":21},[59],[62],[64,65,66,67],{"date":186,"type":38},{"date":188,"type":21},{"date":72,"type":21},{"name":44,"class":45},{"id":212,"slug":4,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":122,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":170,"conditions":215,"keywords":216,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":46},"100582230",{"count":168,"type":21},[59],[172],[172],{"date":186,"type":38},{"date":188,"type":21},{"date":177,"type":21},{"name":44,"class":45},{"id":222,"slug":4,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":224,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":225,"keywords":226,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":230,"locationsCount":46},"100568042","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in the repository, an individual must meet all of the following criteria:\n\n* Must understand and be willing to complete an online informed consent process.\n* Be an adult aged 18 or older.\n* Self-report alcohol or other drug use within the past 30 days.\n* Have a smartphone as their primary mobile phone.\n* Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, uploading historical conversational AI data, and\u002For follow-up surveys.\n* Understand and write in English.\n\n  --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.\n* Live in the United States.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this repository:\n\n1\\. Any impairment severe enough to preclude informed consent or valid self-report.",{"count":82,"type":21},[86,87],[89,90,91],{"date":186,"type":38},{"date":188,"type":21},{"date":95,"type":21},{"name":44,"class":45},{"id":232,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":25,"conditions":235,"keywords":236,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":239,"leadSponsor":240,"locationsCount":46},"100559261",{"count":20,"type":21},[24],[27],[29,30,31,32,33],{"date":186,"type":38},{"date":188,"type":21},{"date":42,"type":21},{"name":44,"class":45},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":46},"100517311","phase-2-semaglutide-therapy-for-alcohol-reduction-star-100517311","NCT06015893","Semaglutide Therapy for Alcohol Reduction (STAR)","Semaglutide Therapy for Alcohol Reduction (STAR): A Proof-of-Concept Phase II Clinical Trial","* INCLUSION CRITERIA:\n\nThis study will enroll adult individuals with a current diagnosis of AUD. Participants will be recruited without any preference to sex, race, religion, or other social variables, but sociodemographic data will be collected for sample characterization and potential use in the analyses. Since self-reported psychological measures that have been validated in English constitute major part of the study assessments, participants need to be able to speak, read, write, and understand English to be in the study.\n\nThe information needed to assess eligibility will be collected under an IRB-approved NIDA IRP\n\nscreening protocol, led by the Office of the Clinical Director (OCD) at the NIDA IRP to assess\n\npotential research participants' eligibility for entering clinical protocols. Additional details can be found in the NIDA screening protocol documents. Furthermore, NIH medical records (from other NIH clinical protocols) and outside medical records may also be used, if available, to determine whether participants fulfill the eligibility criteria.\n\nTo be eligible for this study, an individual must meet all of the following criteria:\n\n* At least 18 years old\n* Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n* Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \\> 7 drinks per week for females or \\> 14 drinks per week for males during the 28-day period prior to screening plus at least four days with \\> 3 drinks for females or \\> 4 drinks for males during the 28-day period prior to screening\n* Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\\u003C 10\n* Able to speak, read, write, and understand English as demonstrated by ability to understand and sign the NIDA screening protocol consent\n* Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from enrolling in this study:\n\n* BMI \\\u003C 23 kg\u002Fm\\^2 or BMI \\>= 50 kg\u002Fm\\^2\n* Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)\n* Most recent blood tests: creatinine \\>= 2 mg\u002FdL, eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2, triglycerides \\> 500 mg\u002Fdl, ALP \\> 4x the upper limit of normal, clinically abnormal lipase levels per study clinician\n* Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) \\>= 6.5 %\n* Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors\n* Current or prior use of semaglutide or tirzepatide\n* Current (within the past 30 days) use of weight-lowering medications\n* Current (within the past 30 days) use of FDA-approved pharmacotherapy for AUD (oral or intramuscular naltrexone, acamprosate, disulfiram)\n* Current (within the past 30 days) use of medications with known interaction with semaglutide\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n* Known ongoing history of alcohol ketoacidosis, gastroparesis, pancreatitis (either acute or chronic), pancreatic carcinoma, gallbladder disease, jaundice, Mallory-Weiss syndrome (esophageal tears secondary to vomiting), esophageal varices, cirrhosis\n* Known history of gastric bypass surgery\n* Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue\n* Known history of suicidal attempts (within the past 24 months) or active suicidal ideation\n* Known history of clinically significant vestibular disorders or motion sickness\n* Known history of clinically significant noise-induced hearing loss or tinnitus\n* Contraindication(s) for brain fMRI\n* Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)\n* Physical and\u002For mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.\n* Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method\n* Any other reason or clinical condition that the investigators judge may interfere with study participation and\u002For be unsafe for a participant","110 Years",{"count":104,"type":21},[251],"PHASE2","Background:\n\nAlcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.\n\nObjective:\n\nTo test if a medication named Semaglutide may reduce alcohol drinking in people with AUD.\n\nWho can participate?\n\nAll Adults aged 18 or older with AUD might be eligible to participate in the study.\n\nWhat will happen during the study?\n\nParticipants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit.\n\nParticipants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine.\n\nThe study medication is given as a shot under the skin each week.\n\nParticipants will undergo different tests throughout the study:\n\nThey will give blood, urine, and saliva samples.\n\nThey will engage in self-paced behavioral therapy on a computer.\n\nThey will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc.\n\nThey will taste several sweet liquids and tell their preferences.\n\nThey will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol.\n\nThey will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet.\n\nThey will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen.\n\nParticipants will have a follow-up visit about 7 weeks after their last shot.",[254,172],"Addiction",[89,256,257,258],"Pharmacotherapy","GLP-1","Semaglutide",{"date":186,"type":38},{"date":261,"type":38},"2023-10-17",{"date":263,"type":21},"2030-12-31",{"name":44,"class":45},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":16,"minAge":165,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":46},"100501275","phase-1-spironolactone-in-alcohol-use-disorder-saud-100501275","NCT05807139","Spironolactone in Alcohol Use Disorder (SAUD)","Spironolactone in Alcohol Use Disorder (SAUD): A Double-Blind, Placebo-Controlled, Ascending Dose, Phase 1b Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to enroll in this study, an individual must meet all of the following criteria:\n\n1. At least 21 years old\n2. Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini- International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n3. At least four days with \\>= 4 drinks for females or \\>= 5 drinks for males during the 28-day period prior to screening, according to alcohol TimeLine Follow Back (TLFB)\n4. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is \\\u003C 10\n5. Able to speak, read, write, and understand English as demonstrated by their ability to understand and sign the consent for the NIDA screening protocol.\n6. Female participants must be postmenopausal for at least one year, surgically sterile, or practicing a highly effective method of birth control before entry and throughout the study and must have negative pregnancy tests at each stage. Examples of highly effective methods of birth control include abstinence, hormonal contraceptives (e.g., certain birth control pills, contraceptive patch, vaginal ring, or implants), intrauterine device (IUD), tubal ligation, or vasectomy.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Most recent blood tests: potassium \\> 5.2 mmol\u002FL; creatinine \\>= 2 mg\u002FdL; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2, hemoglobin A1c (HbA1c) \\> 6.5 %\n2. Clinically significant and\u002For symptomatic hyponatremia, hypomagnesemia, hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI) or designee judgment.\n3. Known history of clinically significant orthostatic hypotension\n4. Known history of hypoaldosteronism, hyperaldosteronism, Addison s disease\n5. Diagnosis of NYHA class III-IV heart failure, or unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)\n6. Current use of any diuretic, angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), potassium supplementation, potassium containing salt substitute, heparin and low molecular weight heparin (LMWH), trimethoprim, lithium, digoxin, cholestyramine\n7. Current use of MR antagonists\n8. Current use of FDA-approved pharmacotherapy for AUD, or seeking treatment for AUD\n9. Known history of prior hypersensitivity reaction to spironolactone or other MR antagonists, or any of the product components\n10. Known history of alcohol withdrawal seizure and delirium tremens.\n11. Physical and\u002For mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.\n12. Pregnancy, intention to become pregnant, or breastfeeding.\n13. Any other reason or clinical condition that the Investigators judge would interfere with study participation and\u002For be unsafe for a participant.","99 Years",{"count":274,"type":21},20,[59],"Background:\n\nAlcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3 medicines have been approved by Food and Drug Administration to treat AUD. Researchers want to find better treatments for AUD. Animal studies found that a medicine called spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is approved to treat high blood pressure, or heart failure in people. It is not approved to treat AUD.\n\nObjective:\n\nTo test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order to understand how the body breaks down spironolactone and if there are any side effects in people who drink alcohol while taking this medicine.\n\nEligibility:\n\nPeople aged 21 and older with AUD.\n\nDesign:\n\nParticipants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months. Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of the medicine. The placebo capsule looks just like the spironolactone capsule but contains no medicine. Participants will not know when they are taking the medicine or the placebo.\n\nParticipants will not drink alcohol until day 6 of each clinic stay. Then they will be asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and their well-being will be measured.\n\nParticipants will undergo other tests in the clinic:\n\nA DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle mass. Participants will lie on an open-top, padded table, then a small arm will scan the full length of their body. The radiation participants will get in this study is about the same as from one regular x-ray.\n\nBlood tests. Participants may feel some discomfort at the site of needle entry.\n\nElectrocardiogram. This test records the heart activity. Sensors are attached to the skin with stickers and removed after a few minutes.\n\nUrine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine.\n\nQuestionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking.",[172],[279,280,172,281,282],"Alcohol Consumption","Alcohol Problems","SPIRONOLACTONE","Mineralocorticoid Receptor",{"date":186,"type":38},{"date":285,"type":38},"2023-07-13",{"date":287,"type":21},"2027-04-30",{"name":44,"class":45},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":122,"sex":16,"minAge":165,"maxAge":55,"enrollmentInfo":296,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":298,"conditions":299,"keywords":302,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":46},"100342953","outcome-inference-in-the-sensory-preconditioning-task-in-opioid-use-disorder-100342953","NCT03745339","Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder","Outcome Inference in the Sensory Preconditioning Task in Opioid-use Disorder","* INCLUSION CRITERIA:\n\nThe enrollment target for the protocol is 120 (40 healthy controls, 40 patients on agonist maintenance, and 40 participants who have met DSM 5 criteria for OUD, but are now abstinent (for at least 3 weeks) and not on agonist maintenance.\n\nAll Participants\n\n* Age between 21 and 65 years inclusive. Rationale: objective olfactory impairment grows more prevalent with age; after age 53, the prevalence is 24.5%, increasing to 62.5 % in people aged 80-97 years.\n* Willing to fast for at least 6 hours prior to the study session and be exposed to food odors. These will be assessed with the \"019 Additional History Form\" questionnaire.\n\nAdditional Criteria for Abstinent OUD group\n\n* History of opioid-use disorder (DSM-5), to be assessed via the Mini International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM-5 (SCID). History of SUDs can include substances in addition to opioids (e.g., cocaine).\n* Abstinent \\> 3 weeks from all illicit substances (tobacco smoking and nondependent drinking permissible), to be assessed via 30-day timeline follow-back calendar. (Current abstinence will be confirmed via urine screen: see exclusion criteria.) Rationale: Although heterogeneity will be considerable, what all enrollees will have in common is having become abstinent from opioids long enough to be past withdrawal symptoms. Their heterogeneity in duration of abstinence and other drug-history measures will enable us to examine relationships between those things and inferencing performance.\n\nAdditional Criteria for In-treatment OUD group\n\n-Current enrollment in treatment for OUD with buprenorphine or methadone (\\>3 weeks on stable dose). Current use of illicit substances during treatment is permissible but not required. Rationale: Again, heterogeneity will be considerable, but what all enrollees will have in common is having sought treatment for their OUD and being currently maintained on an agonist that permits adaptive everyday functioning. Their heterogeneity in ongoing use of illicit substances will enable us to examine relationships between inferencing performance and treatment response.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via Sniffin Sticks threshold test \\\u003C4 or via Sniffin Sticks odor identification test \\\u003C10.\n* History of any neurological condition resulting in inability to perform study task. Examples include but not limited to degenerative processes of the CNS (Parkinson disease, Alzheimer disease); other neurologic diseases (Huntington disease, multiple sclerosis, other motor-neuron diseases); inflammatory conditions (sarcoidosis, Wegener granulomatosis); or significant cerebrovascular disease including (but not limited to) epilepsy, stroke, or meningitis; traumatic brain injury (TBI) or major head trauma with sustained loss of consciousness (\\>30 min). To be assessed by history and physical and evaluation to sign screening consent. Eligibility will be determined based on MAI review of participants ability to perform study task. MAI will consider but is not limited to H and P results for mental status exam, language exam, and attention span exam. Rationale: any of these could impair task performance.\n* History of current (past 12 months) uncontrolled DSM-5 major psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, and PTSD. (Candidates will not be excluded for a history of major psychiatric disorder that is now being successfully treated.) To be assessed by MINI or SCID interview. Rationale: could impair task performance.\n* History of anaphylaxis due to, e.g., significant asthma, food or non-food allergy, or intolerance to odors (including latex, detergents, soaps, etc.). To be assessed by history and physical. Rationale: could make odorant exposure risky.\n* Current use of medications or substances that affect alertness and that cannot be withheld on the morning of the study visit (e.g., barbiturates, benzodiazepines, cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.). To be assessed by history and physical. Whether candidate will be requested to withhold any medication will be determined based on MAI judgment. Additionally, if participant has a BrAC \\>0.08, MAI will use clinical judgement to determine if participant should be rescheduled. Rationale: could impair task performance.\n* For women: pregnancy. To be assessed by history and physical and by urine testing. Rationale: Could affect task performance-physiological and hormonal changes during pregnancy influence rhinological function.\n* Any other medical illness or condition that in the judgment of the investigators is incompatible with study participation.\n\nAdditional criteria for Control Group\n\n* History of a substance-use disorder (except nicotine, for matching purposes), or current use of any drug for nonmedical purposes. Controls, who cannot have a history of OUD, will be assessed by their medical history and physical examination for the presence of any signs or symptoms consistent with opioid withdrawal. Any Control with any sign or symptom consistent with opioid withdrawal will be evaluated by the MAI to rule out opioid withdrawal if possible.\n* Urine positive for any illicit drug. Rationale: Controls should have no drug use. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.\n\nAdditional criteria for Abstinent Group\n\n* Urine positive for any illicit drug. Rationale: Abstinent OUD group should have no drug use in the last 3 weeks which would include the several-day time frame to which urine screens are sensitive. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.\n* Current signs or symptoms of opioid withdrawal. These will be assessed in the Abstinent group via the Clinical Opioid Withdrawal Scale (COWS) and the Subjective Opioid Withdrawal Scale (SOWS).\n\nAdditional criteria for In-treatment OUD group\n\n-Urine negative for opioid agonist that the participant is taking as part of their OUD treatment. Rationale: In-treatment OUD group should be in treatment. A negative test suggests the participant is not adhering to their treatment plan. In-treatment OUD participants may test positive for other substances as well as their opioid agonist because they may have ongoing illicit drug use.",{"count":297,"type":21},150,"Background:\n\nPeople with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors.\n\nObjective:\n\nTo see if performance in a learning task differs between people who have opioid-use disorder and people who don t.\n\nEligibility:\n\nAdults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment.\n\nDesign:\n\nParticipants will have 1 visit that will take up to 5 hours.\n\nBefore the visit, participants will be asked to not eat or drink anything except water for at least 6 hours.\n\nAt the visit, participants will be checked for signs of intoxication.\n\nParticipants will give urine and breath samples.\n\nParticipants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors.\n\nThe odors will come from a sterile tube placed under the nose.\n\nParticipants will have their breathing monitored with a belt around the upper abdomen.\n\nAbout 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days.",[300,301],"Opioid-Related Disorders","Drug Addiction",[254,303,304,305,306],"Orbitofrontal Cortex","Associative Learning","Implicit Learning","Natural History",{"date":186,"type":38},{"date":309,"type":38},"2019-06-07",{"date":311,"type":21},"2026-10-01",{"name":44,"class":45},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":46},"100135709","advanced-functional-and-structural-mri-techniques-for-neuropharmacological-imaging-100135709","NCT01036581","Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging","* Subjects must be between the ages of 18-80, be generally healthy and male or non-pregnant female. Smokers, non-smokers, drug using and non-drug using populations will participate in this study.\n\nINCLUSION CRITERIA:\n\nGeneral:\n\n* Male and non-pregnant female adults between the ages of 18-80.\n* All subjects must be able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded if they:\n\n* Are pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.\n* Are unable to undergo MRI scanning due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts including Copper 7 IUD) or claustrophobia.\n* Have major medical illnesses severe enough to impact data being gathered. Potential exclusions may include a history of chronic uncontrolled hypertension, diabetes, HIV, or other clinically significant medical conditions that may alter the signal being measured.\n* Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders.\n* Have neurological illnesses severe enough to impact data being gathered. Potential exclusions may include seizure disorders, migraine, multiple sclerosis, movement disorders, or history of significant head trauma, CVA, or CNS tumor. The MAI will assess the severity in relation to the potential impact on data.\n* Are non-English speaking. Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS\u002FTRPMS procedures. The inability to effectively communicate MRI and TMS\u002FTRPMS safety procedures could compromise the safety of non-English speaking participants.\n* Are cognitively impaired, as assessed by medical history. A validated IQ test such as the WASI or Shipley-2 may also be considered. Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data. Cognitive impairment may affect one s ability to give informed consent.\n\nSubjects to be considered for Non-Invasive Brain Stimulation (NIBS) will also be excluded if they:\n\n-Are unable to safely undergo a NIBS procedure as assessed by a TMS safety screening form.\n\nAdditional information will be gathered during screening for some experiments. As the purpose of this protocol is to develop imaging techniques, this information will be gathered as needed, depending on the phase of development and specific technique requirements. Based on the scientific and medical requirements of the particular experiment, participants may also be assessed for:\n\n* Age (some experiments may want to target a particular age range. For example, cognitive tasks generally exclude participants over 60, an age when cognitive issues tend to become more commonplace)\n* Left-handedness (if desired for a particular task)\n* Color-blindness (if using a task requiring color discrimination)\n* Drug use diagnosis\n* Use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used). MAI discretion regarding timeframe of allowed use will be based on clinically relevant factors including drug half-life, pharmacology of the drug in question and pattern of use by the participant.","80 Years",{"count":321,"type":21},1000,[126],"Background:\n\n\\- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain.\n\nObjectives:\n\n\\- To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction.\n\nEligibility:\n\n* Individuals between 18 and 80 years of age.\n* Participants may be smokers or nonsmokers, and may use drugs or not use drugs.\n\nDesign:\n\n* During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session.\n* Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan.\n* For each scanning session, participants will have an MRI scan that will last approximately 2 hours.\n* MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide.",[325,129],"Drug Abuse",[327,328,329,330,325],"Magnetic Resonance Imaging (MRI)","Functional Brain Imaging","Magnetic Resonance Spectroscopy","Diffusion Tensor Imaging","2026-06-23",{"date":333,"type":38},"2026-06-24",{"date":335,"type":38},"2003-10-24",{"date":337,"type":21},"2029-12-31",{"name":44,"class":45},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":46},"100480663","defining-neurobiological-links-between-substance-use-and-mental-illness-100480663","NCT05538910","Defining Neurobiological Links Between Substance Use and Mental Illness","* INCLUSION CRITERIA:\n\nTo be eligible for this study, an individual must meet all the following criteria assessed under the currently approved NIDA IRP screening protocol for the evaluation of potential research subjects (here referred to as the NIDA screening protocol). This is a protocol led by the Office of the Clinical Director (OCD) at the National Institute on Drug Abuse Intramural Research Program (NIDA IRP) to assess potential research participants eligibility for entering clinical protocols at the NIDA\u002FIRP. Additional details can be found in the NIDA screening protocol documents. As routinely done at the NIDA IRP, the screening procedures and data collected under the NIDA\n\nscreening protocol will capture information above and beyond what is necessary to determine eligibility for this protocol but allows the Investigators to assess the eligibility criteria for this protocol.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants:\n\n1. Able and willing to provide written informed consent.\n2. Both sexes and all ethnic origins, age between 18 and 60 at the time of consent. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n3. Be generally healthy\n4. Absence of pregnancy and breastfeeding. Justification: study procedures and drugs used in the current protocol may complicate pregnancy or be transferred to nursing children. Assessment tool(s): Urine and\u002For serum pregnancy tests, and clinical interview. Urine pregnancy tests will also be conducted at the beginning of each imaging visit.\n5. Have a Breath Alcohol Value of 0 on all study visit days involving scanning. Participant may be rescheduled if this value is greater than 0.\n\nMDD Subjects:\n\n1. Meet DSM-5 diagnostic criteria for current MDD at screening Clinical judgement will be used to interpret criteria.\n2. Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff.\n3. Current stable serotonin modulating drug (e.g. SSRI\u002FSNRI\u002Fserotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI\n\nRemitted MDD Subjects:\n\n1. Meet DSM-5 diagnostic criteria for remitted MDD (full remission or partial remission or past depression) Clinical judgement will be used to interpret criteria.\n2. HAM-D score indicating no clinically relevant depression as evaluated by clinical staff.\n3. Current stable serotonin modulating drug (e.g. SSRI\u002FSNRI\u002Fserotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI.\n\nControl Subjects (without MDD):\n\n1. In addition to the absence of medical, neurological, and psychiatric illness listed above, control participants must not have current\u002Flifetime MDD. Clinical judgement will be used to interpret criteria.\n2. HAM-D score indicating no clinically-relevant depression as evaluated by clinical staff.\n\nDaily Nicotine Users (Study Arm 2):\n\n1. Uses nicotine daily for at least six months\n2. Positive urine screen for cotinine\n\nEXCLUSION CRITERIA (STUDY ARM 1):\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n2. Lifetime history or current diagnosis of any of the following psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features. The MAI and\u002For PI\u002FLI will reserve the right to exclude based psychiatric history not explicitly described in this criterion\n\n   a. Within the control group, Current\u002Flifetime MDD will be exclusionary for controls. Those currently using antidepressants to treat anxiety disorders typically co-morbid with MDD such as general anxiety disorder and panic disorder will be excluded. The MAI will reserve the right to exclude on the basis of psychiatric history not explicitly described in this criterion.\n3. Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability. Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited during laboratory task performance.\n4. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.\n5. May not have regularly used any nicotine product in the past year; must never have been daily nicotine users for more than 1 month.\n6. Must have an expired carbon monoxide level of less than or equal to 5 ppm and cotinine levels consistent with a non-smoker. Depending on the commercially available test used, a level equivalent to a non-smoker status will be used, ideally indicative of a urine cotinine level of around 10 ng\u002Fml. However, given the known limitations of rapid tests to return specific quantifications of cotinine levels, if the present test is unable to quantify cotinine at this level, the lowest level of detection will be used as a cut off and MAI \u002F PI discretion may be used to determine whether this cut off coupled with participant history and environmental factors indicates personal nicotine use versus secondhand smoke environment.\n7. History of moderate or severe substance use disorder in the past 6 months (other than caffeine)\n8. Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n9. Current use of illegal drugs other than marijuana as measured by urine drug screen Marijuana will not be allowed in the 24 hours prior to scanning based on self-report. Study day can be rescheduled to accommodate.\n10. Participants may not use anticholinergic drugs (i.e., scopolamine), dopamine enhancing drugs (i.e. methylphenidate), or other medications that may impact MRI measures (i.e. benzodiazepines) prior to any scanning visit within a timeframe that is likely to directly\n\n    impact the study questions. MAI discretion regarding timeframe of allowed use will be based on half-life, pharmacology of the drug in question, and pattern of use by the participant. Scanning visit timing can be adjusted to accommodate.\n11. May not use drugs that directly enhance dopamine (i.e., methylphenidate) in the week prior to any scanning visit. Scanning visit timing can be adjusted to accommodate.\n12. Any past or present significant cardiovascular, cerebrovascular, or respiratory conditions, including arrhythmias, acute coronary syndrome, ischemic heart disease, or, uncontrolled hypertension\n13. Body mass index (BMI) lower than 18.5 kg\u002Fm\\^2\n14. Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).\n15. Abnormal structural MRI, significant head trauma, current neurological illness including but not limited to frequent migraines, multiple sclerosis, movement disorder\n16. Lifetime history of significant seizure disorder\n17. Any other serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators would compromise the safety of an individual during participation\n\n    All data collected will be evaluated by members of the study team to decide if there is an existing medical illness that would compromise participation in this research\n18. Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants\n\nExclusion Criteria (Study Arm 2)\n\n1. Subjects with active suicidal ideation where outpatient treatment is determined unsafe.\n2. Current psychiatric symptoms in which the ability to adhere to study protocol is determined to be impaired by clinical staff\u002FMAI (e.g., difficulty understanding or answering questions, difficulty remaining still in the fMRI scanner)\n3. Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability.\n\n   Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited\n\n   during laboratory task performance.\n4. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.\n5. Active severe substance use disorder in the past 6 months (other than caffeine and nicotine)\n6. Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).\n7. Abnormal structural MRI, significant head trauma, current neurological illness likely to impact fMRI signal or ability to comply with study requirements (e.g., staying still in scanner)\n8. Any serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators, would compromise the safety of an individual during participation. All data collected will be evaluated by members of the study team to decide if there is an existing medical illness that would compromise participation in this research\n9. Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants",{"count":346,"type":21},620,[126],"Background:\n\nNicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD.\n\nObjective:\n\nTo understand how nicotine affects symptoms of depression and related brain function.\n\nEligibility:\n\nPeople aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products.\n\nDesign:\n\nParticipants will have 2 or 3 study visits over 1 year.\n\nParticipants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs.\n\nBefore each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan.\n\nFor each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours.\n\nParticipants will answer questions about their thoughts, feelings, and behaviors before and after each scan.\n\nThey will have a blood test after each scan.",[350,132,27],"Major Depressive Disorder",[31,352,353,354],"Reward Function","Affective Processing","Interoceptive Awareness","2026-06-19",{"date":331,"type":38},{"date":358,"type":38},"2023-02-02",{"date":137,"type":21},{"name":44,"class":45},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":46},"100316015","mechanism-of-non-invasive-magnetic-stimulation-100316015","NCT03394066","Mechanism of Non-invasive Magnetic Stimulation","Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation","* INCLUSION CRITERIA:\n\nSubjects must be:\n\n1. 18 - 60 years of age.\n\n   -Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.\n\n   --Screening tool: History.\n2. In good health.\n\n   * Justification: Many illnesses may alter neural functioning as well as fMRI signals.\n   * Screening tools: Vital Signs, height\u002Fweight measurements, Medical History, Physical Examination, and lab tests. Labs may include, but are not limited to: CBC, Hemoglobin A1C, CMP, ESR, and salivary HIV (blood may be tested for HIV if needed to confirm a positive salivary test). Elevated serum glucose may be followed up to assess for diabetes. MAI will assess if participants are generally healthy and will make the final judgment on any questionable lab results.\n3. Right-handed.\n\n   * Justification: Using right-handed individuals will reduce variability in BOLD MRI data.\n   * Screening tool: self-report.\n\nEXCLUSION CRITERIA:\n\n1. Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days.\n\n   * Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Neurological symptoms could potentially alter BOLD signal.\n   * Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.\n2. First-degree family history of any form of epilepsy with a potentially hereditary basis.\n\n   * Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.\n   * Screening tool: TMS safety screening, Medical History.\n3. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, -shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes either MRI scanning or TMS intervention.\n\n   * Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.\n   * Screening tool: TMS safety screening, MRI safety screening, Medical History.\n4. Any contraindications to MRI or TMS.\n\n   * Justification: There are additional contraindications that would exclude participation in MRI or TMS (e.g., claustrophobia).\n   * Screening tool: MRI safety screening, TMS Safety Screening, and mock scanner trial if deemed necessary.\n5. Noise-induced hearing loss or tinnitus.\n\n   * Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment.\n   * Screening tools: TMS safety screening.\n6. Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action.\n\n   * Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.\n   * Screening tools: MRI safety screening questionnaire and Medical history. A Urine toxicology that analyzes for presence of a broad range of prescription and nonprescription drugs may also be completed per the NIDA IRP screening protocol.\n7. Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.\n\n   * Justification: The population of interest here is a healthy control population with no psychiatric disorders. In subjects with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. Psychiatric symptoms could potentially alter BOLD signal.\n   * Screening tools: a mental health screening questionnaire and \u002For a semi-structured or structured psychiatric interview such as the Structured Clinical Interview for the DSM (SCID) or clinician assessment. Potential diagnoses will be further evaluated by a mental health professional.\n8. Current use of nicotine or history more than about 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.\n\n   * Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required.\n   * Screening tools: Self-report and CO \\\u003C 6. A commercial urine cotinine test may also be used, with the expectation that results correspond to non-smoker status for the specific test being used, typically corresponding to a urine cotinine under about 20 ng\u002Fml.\n9. Meet current DSM-5 criteria for any substance use disorder, smoke daily, or urine toxicology positive for any illicit substance inconsistent with history given.\n\n   * Justification: The population of interest here is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS.\n   * Screening tools: a drug use survey (DUS) and urine qualitative drug screen for common drugs of abuse. SUD may also be evaluated in a structured\u002Fsemi-structured psychiatric interview such as the SCID and follow up with a mental health professional). Participants who test positive at screening (under the NIDA IRP screening protocol) may be assessed for current intoxication. For participants who are not found to be currently intoxicated, screening staff will assess for SUD and coherence of their drug use history and toxicology with particular attention to substances for which they are positive and may require a return screening visit to demonstrate ability to produce a negative urine before allowing them to proceed to clearance for this study.\n10. Have met DSM-5 criteria for any substance use disorder in the past.\n\n    * Justification: the population of interest here is a healthy control population with no present or past substance use disorder.\n    * Screening tools: a drug use survey (DUS) and\u002For a structured\u002Fsemi-structured psychiatric interview such as the SCID and follow up with a mental health professional).\n11. Pregnant individuals or those with reproductive potential who are sexually active and not using an acceptable form of contraception.\n\n    * Justification: it is unknown whether TMS or MRI poses a risk to fetuses.\n    * Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI.\n12. Participation in a TMS session less than two weeks ago.\n\n    * Justification: in order to limit exposure to TMS, we will not enroll subjects who have received TMS less than two weeks ago.\n    * Screening tool: TMS safety screening questionnaire, and\u002For medical history.\n13. History of learning disability, current ADHD or cognitive impairment\n\n    * Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions and may introduce significant variably into the data.\n    * Screening tool: self-report of special education classes, history of specific learning disability or mental retardation, and medical history. A validated IQ test such as Wechsler Abbreviated Scale of Intelligence (WASI) or Shipley-2 may also be completed.\n14. Non-English Speaking\n\n    * Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS procedures. The inability to effectively communicate MRI and TMS safety procedures could compromise the safety of non-English speaking participants.\n    * Screening tool: self-report.",{"count":369,"type":21},70,[126],"Background:\n\nTranscranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.\n\nObjectives:\n\nTo learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.\n\nEligibility:\n\nHealthy, right-handed adults ages 18-60 who are non-drug users.\n\nDesign:\n\nParticipants will be screened under protocol 06-DA-N415.\n\nParticipants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.\n\nEach visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.\n\nParticipants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.\n\nThe other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.\n\nParticipants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.",[62],[374,375],"Repetitive TMS (rTMS)","Simultaneous TMS and MRI","2026-06-18",{"date":378,"type":38},"2026-06-22",{"date":380,"type":38},"2018-09-19",{"date":382,"type":21},"2026-12-31",{"name":44,"class":45},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":46},"100608639","phase-1-phase-1-study-of-oral-mg001-100608639","NCT07204171","Phase 1 Study of Oral MG001","Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral MG001","Inclusion Criteria:\n\n1. Is a healthy male or female volunteer between 18 and 65 years of age, inclusive, at the time of consent.\n2. Has a body mass index (BMI) within the range of 18.0 to 32.0 kg\u002Fm2 and a minimum weight of at least 50.0 kg at screening.\n3. Has a recent history of oral opioid use , defined as using prescription or recreational oral opioids at least once during the 30-day period preceding screening.\n4. Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.\n5. Has no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory test , vital signs, and 12-lead ECG.\n6. A female study participant must be of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation\u002Focclusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU\u002FmL).\n\n   If a male study participant that engages in sexual activity that has the risk of pregnancy, must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.\n7. Is able and willing to comply with protocol requirements and the rules and regulations of the study site and is likely to complete all the study treatments.\n\nExclusion Criteria:\n\n1. Has any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs (including hemoglobin saturation assessed by pulse oximetry, RR, HR, BP, oral body temperature ), or ECGs that contraindicate participation in the study. This includes but is not limited to history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI) , pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.\n2. Has clinically significant psychiatric symptoms and\u002For psychiatric comorbidities (schizophrenia, bipolar disorders, mania, unipolar depression, disruptive behaviors, etc.), or a history of such within one year of screening. Psychiatric assessment will be conducted by a Qualified Mental Health Professional using the Mini-International Neuropsychiatric Interview (MINI).\n3. Has a history of suicide attempts or evidence of suicidal ideation based on the Columbia-Suicide Severity Rating Scale (C-SSRS):\n\n   * Any lifetime history of serious or recurrent suicidal behavior.\n   * Previous history of suicidal behaviors in the past 10 years.\n   * Suicidal ideation with or without a plan (active or passive, respectively) in the past year.\n4. Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study clinician.\n5. Has a history of thyroid and\u002For parathyroid disease or abnormal T4 or PTH levels.\n6. Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study.\n7. Has any clinically significant abnormal laboratory values\n8. Has taken kratom or any investigational drug in another study within 30 days of study consent.\n9. Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period.\n10. Has used opioids intravenously or on 3 or more consecutive days during the 30 day period preceding screening.\n11. Has a sitting systolic blood pressure (SBP) \\>140 mmHg, diastolic BP (DBP) \\>90 mmHg or HR \\\u003C50 or \\>100 beats per minute (BPM) at screening and clinic intake.\n12. Has orthostatic hypotension, defined as a 20 mmHg reduction in SBP and 10 mmHg in DBP.\n13. Has an O2 saturation, defined as the percentage of hemoglobin in the blood that is carrying oxygen, below 95% from a 10 second reading.\n14. Has donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.\n15. Has donated plasma within 7 days prior to screening.\n16. Has taken any concomitant medications, including prescription, over-the-counter, dietary supplements, herbal products, vitamins, or medications interacting with CYP3A4, CYP2D6, or CYP1A2 within 14 days or 5-half-lives (whichever is longer) prior to study drug administration, and throughout the study.",{"count":392,"type":21},32,[59],"This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. The purpose of this study is to understand how safe MG001 is, how well it is tolerated, and how the body processes it. About 32 healthy adult volunteers, both men and women, will take part. Before joining, participants will undergo screening tests up to four weeks in advance to make sure they are eligible and healthy enough. On the day before dosing, participants will be admitted to the clinic for final health checks, and those who qualify will be randomly assigned-by chance, like flipping a coin-to receive either a single dose of MG001 or a placebo (an inactive substance). Neither the participants nor the staff giving the medicine will know which one is given. The study drug will be administered after at least 10 hours of fasting, and participants will then remain in the research clinic under close medical observation for three nights, until Day 4. During this time, doctors and nurses will monitor participants' health, look for any side effects, and collect blood samples to see how MG001 moves through the body. A follow-up clinic visit on Day 7 will provide one last check-in and blood test. This design helps researchers gather important first information on the safety and tolerability of MG001, while protecting the health and well-being of participants.",[396],"Safety and Tolerability in Healthy Subjects",[398,399,400,401],"mitragynine","kratom","opioid use disorder","opioid withdrawal","2026-06-15",{"date":404,"type":38},"2026-06-16",{"date":406,"type":21},"2026-09",{"date":408,"type":21},"2027-04",{"name":44,"class":45},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":272,"enrollmentInfo":417,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":46},"100558563","screening-evaluation-and-assessment-sea-protocol-at-the-nida-irp-100558563","NCT06552741","Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP","Screening, Evaluation, and Assessment (SEA) Protocol at the NIDA IRP","* INCLUSION CRITERIA:\n\nThis protocol is seeking individuals with current or past SUDs and\u002For AUD, as well as those who have never had an SUD or AUD. These individuals also may or may not be in treatment for their AUD\u002FSUDs.\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n* Age 18-99 years old.\n* Proficient ability to read, write, and understand English.\n* Stated willingness to comply with all screening procedures and availability for the duration of the screening period\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nIndividuals who lack capacity to consent to research participation to this protocol as determined by the Evaluation to Sign Consent (ESC).",{"count":82,"type":21},"Background:\n\nPeople who will participate in research studies need to undergo proper screening, evaluation, and assessment (SEA). SEA helps keep those who participate in studies safe. It also helps ensure accurate study results. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) wants to screen people with alcohol and\u002For substance use disorders (ASUD) as well as people without ASUD for ongoing studies at NIDA in Baltimore, MD\n\nObjective:\n\nTo screen people with or without ASUD for ongoing studies at NIDA. The ultimate goals are to learn why some people (1) use drugs; (2) stop using drugs; (3) use drugs but do not get addicted; and (4) never use drugs snd to develop ASUD treatments.\n\nEligibility:\n\nPeople aged 18 years and older. They may (1) currently use nicotine, alcohol, opioids, cocaine, or other drugs; (2) no longer use them; or (3) have never used them.\n\nDesign:\n\nParticipants will have 1 screening visit that could last up to 8 hours. The visit may be split over more than 1 day. The duration of the screening may vary for each individual based on which studies they are interested in and screened for. The tests they undergo may vary and may include the following:\n\n* Physical exam.\n* Blood, saliva, and urine tests.\n* Breath samples that test for alcohol and carbon monoxide.\n* Test of heart function.\n* Smell test that measures sense of smell.\n* Tests of memory, attention, and thinking.\n* Mental health evaluation.\n* Mock magnetic resonance imaging (MRI) scan.\n* Questionnaires about alcohol and other drug use, mental health, medical history, and life in general.",[132,172],[89,421,422,423,424,425,426,427,428],"Drug","Smoking","Substance","Opioid","Nicotine","Cocaine","CONTROL","Vaping","2026-06-02",{"date":431,"type":38},"2026-06-03",{"date":433,"type":38},"2024-09-04",{"date":435,"type":21},"2047-01-01",{"name":44,"class":45},{"id":438,"slug":4,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":458},"100534051","NCT06233799","Trial of Naltrexone\u002FBupropion for the Treatment of Methamphetamine Use Disorder","Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection\u002FBupropion XL Tablets in the Treatment of Methamphetamine Use Disorder","Inclusion Criteria:\n\n1. Is 18 to 65 years of age;\n2. Meets DSM-5 criteria for moderate or severe MUD (4 or more criteria);\n3. Is interested in reducing or stopping MA use;\n4. Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;\n5. Self-reports MA use on 18 or more days in the 30-day period prior to consent using the Timeline Followback (TLFB);\n6. Provides at least 2 urine samples positive for MA out of up to 3 tests, which will occur at least 2 days apart within a 10-day period;\n7. If assigned as female at birth and\u002For currently has a uterus, is not pregnant, agrees to use acceptable birth control methods, and have periodic urine pregnancy testing done during participation in the study unless documentation of hysterectomy provided;\n8. Is not physically dependent on opioids and meets subjective and objective measures of being opioid-free prior to naltrexone injection per study medical clinician's determination, including, if clinically required, a negative naloxone challenge;\n9. Is willing to comply with all study procedures and medication instructions;\n10. Agrees to use a smartphone app (downloaded for free to own device or on a study provided smartphone device) to take daily videos of medication dosing.\n\nExclusion Criteria:\n\n1. Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;\n2. Has suicidal or homicidal ideation that requires immediate attention;\n3. Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician;\n4. Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study;\n5. Has Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160\u002F100 in 2 out of 3 readings during screening);\n6. Has any elevated bilirubin test value per laboratory criteria OR any other liver function test (LFT) value \\> 5 times the upper limit of normal per laboratory criteria;\n7. Has a platelet count \\\u003C100 x 10exp3\u002Fmicroliter;\n8. Has a body habitus that precludes gluteal intramuscular injection of XR-NTX in accordance with the administration equipment (needle) and procedures;\n9. Has a known allergy or sensitivity to bupropion, naloxone, naltrexone, PLG (polyactideco-glycolide), carboxymethylcellulose or any other component of the XR-NTX diluents;\n10. Has been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;\n11. Has taken an investigational drug in another study within 30 days of study consent;\n12. Has been prescribed and taken naltrexone or bupropion within 30 days of study consent;\n13. Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder (SUD) treatment services;\n14. Is receiving ongoing treatment with tricyclic antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications;\n15. Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician;\n16. Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period;\n17. Has a surgery planned or scheduled during the study period;\n18. Is currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities;\n19. If assigned as female at birth and\u002For currently has a uterus, is currently pregnant, breastfeeding, or planning on conception.",{"count":444,"type":21},360,[446],"PHASE3","The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL (XR-NTX\u002FBUP-XL) compared to matched injectable and oral placebo (iPLB\u002FoPLB) in reducing methamphetamine (MA) use in individuals with moderate or severe methamphetamine use disorder (MUD) seeking to stop or reduce MA use.",[449,450],"Methamphetamine-dependence","Methamphetamine Abuse","2026-06-01",{"date":453,"type":38},"2026-06-04",{"date":455,"type":38},"2024-07-01",{"date":287,"type":21},{"name":44,"class":45},11,{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":465,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":46},"100493642","development-and-validation-of-learning-and-decision-making-tasks-100493642","NCT05707806","Development and Validation of Learning and Decision-Making Tasks","* INCLUSION CRITERIA:\n\nThere are two levels of inclusion and exclusion criteria; those applying to all participants and those applying to participants in the 'MRI' phase only. Participants will be cleared for both the behavioral and MRI phases, if eligible, and will be invited to sign one or both consents depending on what tasks are active at the time of consent. If a person is not MRI compatible, they will only be offered enrollment into the behavioral phase of the study.\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Male or female, aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n2. In good general health.\n\n   In order to be eligible to participate in the MRI phase of this study, an individual must - in addition - also meet all of the following criteria:\n3. Right-handed.\n\nEXCLUSION CRITERIA:\n\nIndividuals who meet any of the following criteria will be excluded from participation:\n\n1. History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, CNS tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.\n2. History of currently unresolved psychiatric disorders with current (past 12 months) regular use of psychiatric medications. Past\u002Fremitted (\\>12 months ago) psychiatric disorders with no currently active symptoms and no current use of psychiatric medications may be included in the study, per MAI discretion.\n3. Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n4. Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks in the past 12 months.\n5. Current use of psychoactive medications and medications that affect alertness and that cannot (in principle) be withheld the night before the study visit. Participants who can withhold these medications will either (1) withhold the medication during this time or (2) not withhold the medication and pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI\u002FPI judgement, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled and asked to withhold the medication.\n6. For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the study itself.\n7. Uncorrected impairments in visual acuity.\n8. Non-English speaking. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n9. Pregnancy.\n10. Any other condition that in the judgment of the investigators is incompatible with participation.\n\n    An individual who meets any of the following criteria will be excluded from participation in the MRI phase of this study:\n11. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.",{"count":466,"type":21},550,"Background:\n\nSubstance use disorders (SUD) can be considered disorders in the way people process incentives, learn, and make decisions. To understand why some people develop SUD, researchers need to develop reliable tests that show how people think and learn. This natural history study seeks to develop a set of tasks that could then be used to test how people learn and make decisions.\n\nObjective:\n\nTo develop and validate behavioral tasks that could be used in future studies.\n\nEligibility:\n\nHealthy people aged 18-45 years from the Baltimore area. They must also be enrolled in the NIDA screening protocol.\n\nDesign:\n\nParticipants will perform different tasks. Most tasks require 1-4 study visits; some may require up to 12. Visits are 1-14 days apart. All visits will last about 1-7 hours.\n\nParticipants will perform tasks on a computer. As they work they may be given different stimuli:\n\nSmells. Participants will sniff odors through a plastic tube or mask on their nose.\n\nFlavors. Participants will wear a mouthpiece and small amounts of different flavored liquids will be placed in their mouth.\n\nPictures. Participants will look at different images.\n\nSounds. Participants will wear headphones and various sounds will be played for them.\n\nFood. Participants may be asked to eat a meal before, during, or after a task. The researchers will provide the meal.\n\nDuring each task, participants will wear sensors to monitor their heart rate, blood pressure, breathing, and other physical changes in their bodies.\n\nSome participants will have a functional magnetic resonance imaging (fMRI) scan. They will lie on a table that slides into a cylinder. They will perform tasks on a computer screen during the fMRI.",[27],[33,31,470,30,306],"Incentive Pocessing","2026-05-28",{"date":473,"type":38},"2026-05-29",{"date":475,"type":38},"2023-03-29",{"date":477,"type":21},"2032-12-31",{"name":44,"class":45},{"id":480,"slug":4,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":127,"conditions":484,"keywords":485,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":490,"locationsCount":46},"100487722","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants\n\n* Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.\n* Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent.\n\nNicotine Dependence Arm\n\n-Participants must smoke\u002Fvape a minimum of 4 times per week with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng\u002Fml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nAll Participants\n\n* Participants cannot meet DSM-5 criteria for lifetime and\u002For current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.\n* Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.\n* Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.\n* Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary.\n* Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.\n* Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics.\n* Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant.\n* Individuals with severe hepatic impairment will be excluded\n* Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35.\n* Participants cannot be using a CYP3A inhibitor\u002Finducer (metabolism by CYP3A is the major elimination pathway for suvorexant)\n* Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome, ischemic heart disease, or uncontrolled hypertension.\n* Participants cannot have narcolepsy.\n* Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls.\n* Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months.\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n* Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Contraindication to MRI as determined by MRI Safety Screening form.\n\nNicotine Dependent Arm\n\n* Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.\n* Participants cannot meet DSM-5 criteria for moderate or severe ADHD.\n\nControl Arm\n\n* May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm.\n* Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and\u002For designee.\n* Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n* May not have (or currently be treated\u002Fmedicated for) any diagnoses\u002Fconditions contraindicated for use of methylphenidate.\n* Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.",{"count":124,"type":21},[126],[129],[131,31,132,129],"2026-05-27",{"date":471,"type":38},{"date":135,"type":38},{"date":137,"type":21},{"name":44,"class":45},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":122,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":505,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":46},"100578256","phase-1-vk4-116-phase-i-study-with-food-effect-100578256","NCT06808932","VK4-116 Phase I Study With Food-Effect","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study With Food-Effect Cohort to Assess the Safety, Tolerability, and Pharmacokinetics of Oral (R) VK4-116 in Healthy Volunteers","Inclusion Criteria:\n\n1. Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent.\n\n   • The masculine \u002F feminine gender is used without any discrimination and with the aim to lighten the text.\n2. Have a body mass index (BMI) within a range of 17.0 to 36.0 kg\u002Fm2 and a minimum weight of at least 50.0 kg at screening.\n3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.\n4. Have no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.\n5. A female study participant must meet one of the following criteria:\n\n   * If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:\n\n     i. abstinence from heterosexual intercourse, ii. hormonal contraceptives (e.g., injectable\u002Fimplant\u002Finsertable hormonal birth control products, transdermal patch), iii. intrauterine device (with or without hormones). OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.\n   * If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation\u002Focclusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU\u002FmL).\n\n   A male study participant that engages in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.\n6. Be able and willing to comply with protocol requirements and the rules and regulations of the study site, and be likely to complete all the study treatments.\n\nExclusion Criteria:\n\n1. Have any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study. This includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.\n2. Use nicotine products via smoking\u002Fvaping in past 6 months.\n3. Have a sitting systolic blood pressure (BP) \\>140 mmHg, diastolic BP \\>90 mmHg and heart rate (HR) \\\u003C45 or \\>100 beats per minute (BPM) at screening and clinic intake.\n4. History of unstable angina; a history of myocardial infarction; or a history of a clinically significant cardiac arrhythmia,\n5. Has a QT interval corrected for heart rate using Fredericia formula \\>450 milliseconds in males or \\>470 milliseconds in females, or evidence of left bundle branch blocks (Note: right bundle branch block is acceptable), second or third degree AV block, or evidence of left ventricular hypertrophy on ECG\n6. Have a history of liver disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), 2 × the upper limit of normal (ULN).\n7. Have a history of renal disease or current renal function test values as follows:\n\n   * blood urea nitrogen (BUN) \\>2 × ULN,\n   * creatinine (Cr) \\>1.5 mg\u002FdL.\n8. Have donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.\n9. Have donated plasma within 7 days prior to screening.\n10. Have hemoglobin value of \\\u003C13 g\u002FdL for men and \\\u003C12 g\u002FdL for women.\n11. Have undergone treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.\n12. Have taken prescribed medications within 14 days of Day -1 or over-the-counter medications, dietary supplements, herbal products, or vitamins within 7 days or 5 half-lives (if known), whichever is longer, of Day -1.\n13. Have a positive urine drug test for alcohol, opioids (e.g., codeine, heroin, fentanyl, morphine, oxycodone, etc.), cocaine, amphetamine, methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), benzodiazepines, tetrahydrocannabinol (THC), barbiturates, propoxyphene, or phencyclidine\u002Fphenylcyclohexyl piperidine (PCP) at admission.\n14. Have a history of suicide attempts or current or recent evidence of suicidal ideation in the past 12 months based on the Columbia-Suicide Severity Rating Scale (C-SSRS).\n15. Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).\n16. Have positive results for a coronavirus disease 2019 (COVID-19) test.\n17. Have a history of anaphylaxis and known allergy to any drug formulation.\n18. Have a history of consumption of any product containing grapefruit, pomelo, Seville oranges, or alcohol within 7 days before study drug dosing on Day 1.\n19. Have consumed any product containing caffeine or xanthine within 24 hours before study drug dosing on Day 1",{"count":499,"type":21},48,[59],"This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study is designed to assess the safety, tolerability and pharmacokinetics of VK4-116 in healthy volunteers in fasted and fed state.",[503,504],"Opioid Dependence","Opioid Use Disorder (OUD)",[506,507,508],"addiction","dopamine","dopamine receptor","2026-04-06",{"date":511,"type":38},"2026-04-09",{"date":513,"type":21},"2026-08-01",{"date":515,"type":21},"2027-08-30",{"name":44,"class":45},""]