[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-drinking\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-drinking":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,48,78,109,130,156,177,198,223,258,293,315,339,363,392,419,447,473,496,519,543,571,596,629,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100308373","phase-1-nicotinic-receptor-genetic-variation-and-alcohol-reward-100308373",false,"NCT03294460","Nicotinic Receptor Genetic Variation and Alcohol Reward","* This study will include healthy male and female participants from the general population prospectively genotyped to obtain balanced samples of four groups of participants based on their smoking status (smokers and non-smokers) and CHRNA5 rs16969968 genotype: 1). A-allele carriers (AA or AG genotype), and 2). G-allele homozygotes (GG genotype). The study will be open to all racial and ethnic groups, as long as the individual meets the genotype criteria.\n\nInclusion and exclusion criteria will be evaluated from the data collected under the Natural History Protocol or screening update visit under this protocol.\n\nINCLUSION CRITERIA:\n\n1. Male and female participants between 21-60 years of age. \\[assessment: identification provided to Clinical Center Admissions office\\]\n2. Smoking status:\n\n   * Smokers will have a history of at least 1 year of daily smoking, defined as individuals who smoke more than 20 uses of nicotinic products\u002Fweek on average, and a cotinine level, measured by the NarcoCheck PreDosage Nicotine Test \\[PNT\\] test, of \\>= 2. \\[assessment: Smoking history questionnaire, Additional medical history, PreDosage Nicotine test\\]\n   * Non-smokers with no history of smoking in the past year and less than 20 uses of nicotinic products lifetime.\\[assessment: smoking history questionnaire, Additional medical history\\]\n3. Inclusion criteria for women: Use of adequate method of birth control during the study, if female is sexually active and is not surgically sterilized. Adequate methods of contraception include: use of oral contraceptives; use of barrier method of contraceptive; use of an approved IUD or other long-acting reversible contraceptive \\[LARC\\]; have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner\\[s\\]. Justification: To minimize the risk of administering alcohol to pregnant women, given the known effects of alcohol exposure on fetuses. \\[assessment: medical history\\]\n\nEXCLUSION CRITERIA:\n\n1. Non-English speaking individuals. Justification: The study materials, MRI tasks and\n\n   assessments (including the outcome measures) are validated only in English language.\n2. Current or prior history of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders. Justification: Many illnesses may alter the neuropsychological effects of alcohol as well as MRI measures. \\[assessment: clinically significant findings on medical history and physical exam, ECG, laboratory tests\\]\n3. Positive hepatitis \\[A, B antigen, or C\\], or HIV test at screening. Justification: Hepatitis can alter liver function and alcohol pharmacokinetics. HIV infection can alter brain function. \\[assessment: laboratory tests\\]\n4. Current \\[past 12 months\\] history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders. Justification: Concurrent psychopathology can alter brain function and alcohol response. \\[assessment: SCID interview\\]\n5. Lifetime history of psychotic disorders, obsessive compulsive disorder \\[OCD\\], post-traumatic stress disorder \\[PTSD\\], or eating disorder. Justification: These disorders can have long-term effects on brain function and alcohol response. \\[assessment: SCID interview\\]\n6. Current or lifetime diagnosis of alcohol or substance use disorder. Past mild AUD or past mild SUD with no current symptoms for atleast 2 years will not be exclusionary. Justification: History of moderate to severe alcohol or substance use disorder will impact brain function and alcohol response. We do not anticipate past mild AUD or SUD in remission for 2+ years would have such impact on brain function and alcohol response. We will examine this in our exploratory analysis. We will also do a follow-up telephone\u002Fteleheath visit with these participants to assess any changes in alcohol or substance use or problems related to their participation in the study \\[assessment: SCID interview\\]\n7. Currently seeking treatment for alcohol use disorders. Justification: It would be unethical to administer alcohol to individuals seeking treatment for alcohol problems. Also, this study does not provide treatment for individuals with alcohol use disorder. \\[assessment: medical history\\]\n8. History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms \\[Clinical Institute Withdrawal Assessment \\[CIWA\\] score \\> 8\\] at screening. Justification: Withdrawal symptoms would be indicative of alcohol use disorder, which is already an exclusion criteria. Additionally, withdrawal symptoms would be a major safety concern for participants, and a major confound in the assessment of alcohol response and brain function. \\[assessment: CIWA assessment\\]\n9. Non-drinkers \\[alcohol-naive individuals or current abstainers\\] or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime. Justification: It would be unethical to administer alcohol to individuals that do not drink alcohol. \\[assessment: Timeline Follow Back, Lifetime Drinking History, Additional History Form and medical history\\]\n10. Positive result on urine drug screen or positive breathalyzer during screening visit. Positive urine drug screen or breathalyzer reading during more than 1 study visit will result in participant withdrawal from the study. Justification: Current or recent exposure to alcohol or drugs of abuse could impact brain function and alcohol response. \\[assessment: laboratory tests and breathalyzer test.\n11. Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks. Justification: It would not be safe to administer alcohol to individuals with the highly aversive flushing response to alcohol. \\[assessment: alcohol flushing questionnaire\\]\n12. Medication exclusion criteria:\n\n    * Use of prescription or OTC medications known to interact with alcohol 2 weeks prior to screening or screening update visit. These include, but may not be limited to: isosorbide; nitroglycerine; benzodiazepines; warfarin; anti-depressants such as amitriptyline, clomipramine and nefazodone; anti-diabetes medications such as glyburide, metformin and tolbutamide; H2-antagonists for heartburn such as famotidine, cimetidine and ranitidine; muscle relaxants; anti-epileptics including phenytoin and phenobarbital; codeine and opioid analgesics including Darvocet, Percocet and hydrocodone;\n    * Regular (more than once a week) or prescribed use of the following medications and unable to refrain from these medications for 48 hours prior to study visits: anti-histamines, pain medicines, and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib, and naproxen.\n    * Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to screening. These include chlorzoxazone, isoniazid, metronidazole, and disulfiram.\n    * Use of drugs known to affect hemodynamic response 2 weeks prior to screening or screening update visit. These include antihypertensives, insulin, and thyroid medications.\n\n    Note that any discontinuation of medications will only be done at the recommendation of a physician. \\[assessment: medical history and physical exam\\]\n13. Exclusion criteria for MRI:\n\n    * Left-handedness \\[Edinburgh Handedness Scale\\]. Justification: To avoid lateralized effects on brain function measures and reduce potential variance in MRI signals.\n    * Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head \\[including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments\\].\n    * Fear of enclosed spaces. Justification: To minimize risk and discomfort.\n    * Inability to lie comfortable on back for up to 2 hours in the MRI scanner. Justification: To minimize risk and discomfort. \\[assessment: NIAAA MRI Safety Screening Questionnaire\\]\n14. Exclusion criteria for women: Justification: To minimize the risk of administering alcohol to pregnant or nursing women, given the known effects of alcohol exposure on fetuses and infants.\n\n    * Pregnant \\[assessment: urine beta-hCG test at screening\\]. Women must also test negative on urine beta-hCG test at the start of every study visit.\n    * Breast-feeding \\[assessment: medical history and physical exam\\].\n\nScreen Failures:\n\nScreen failures are defined as participants who consent to participate in the clinical trial but are not subsequently assigned to the study intervention or entered in the study. A minimal set of screen failure information is required to ensure transparent reporting of screen failure participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory authorities. Minimal information includes demography, screen failure details, eligibility criteria, and any serious adverse event (SAE).\n\nIndividuals who do not meet the criteria for participation in this trial (screen failure) because of a positive drug test, positive pregnancy test or positive breathalyzer reading may be rescreened. Rescreened participants should be assigned the same participant number as for the initial screening.",true,"ALL","21 Years","60 Years",{"count":21,"type":22},128,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nPeople with the brain disease AUD (alcohol use disorder) have a serious problem with drinking. Researchers want to study how different people react to alcohol, and how genes affect this. They will focus on a nicotine receptor gene that may increase a person s AUD risk.\n\nObjectives:\n\nTo see if people with variations of a nicotine receptor gene take alcohol differently and have different brain responses to alcohol cues.\n\nEligibility:\n\nHealthy adults ages 21 - 60. This study includes smokers and non-smokers.\n\nDesign:\n\nParticipation will be based on evaluation under the NIAAA natural history protocol (14-AA-0181) or a screening visit under this protocol.\n\nParticipants will have two 9-hour visits. They must have no alcohol or non-prescription drugs before all visits and no food or drink before the first visit.\n\nAt every visit, participants will:\n\n* Get a light meal\n* Have breath and urine tests\n* Get taxi rides there and back\n\nAt visits 1, participants will:\n\n* Have a thin plastic tube inserted in an arm and connected to a pump for alcohol infusion.\n* Have sensors on their chest to monitor heart rate.\n* Sit in a chair for 2.5 hours and get alcohol by pushing a button. Their breath alcohol level will be monitored.\n* Answer questions about mood and effects of alcohol\n* Give blood samples\n* Relax at the clinic while their breath alcohol level drops\n\nAt visit 2, participants will:\n\n* Answer questions and do computer tests\n* Have an alcoholic drink and a snack\n* Have a magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of the brain. They will do computer tasks.\n* Have another drink and snack\n* Relax until their alcohol level drops\n\nParticipants will have a follow-up call after each visit.",[28],"Alcohol Drinking",[30,31,32,33,34],"Functional Magnetic Resonance Imaging (fMRI)","Alcohol Use","Polymorphism, Genetic","Magnetic Resonance Imaging (MRI)","Smoking","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2019-06-10",{"date":43,"type":22},"2026-12-31",{"name":45,"class":46},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":47},"100217453","behavioral-and-functional-task-development-implementation-and-testing-100217453","NCT02108054","Behavioral and Functional Task Development, Implementation, and Testing","* INCLUSION CRITERIA:\n* between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies\\*.\n\nEXCLUSION CRITERIA:\n\n* Are not cleared on a neuromotor examination\n* Are currently receiving psychotropic medication\n* Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the\n\npast 30 days CIWA score \\> 8).\n\n-MRI Exclusion Criteria:\n\n* Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;\n* Are pregnant, as determined by a negative pregnancy test\n* Left handed\n* Claustrophobia.\n\n  * To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.","18 Years","65 Years",{"count":57,"type":22},400,[59],"NA","Background:\n\n\\- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.\n\nObjective:\n\n\\- To develop tasks that investigate a person s behavior that can be used in later studies.\n\nEligibility:\n\n* Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old.\n* Healthy right-handed volunteers 18-65 years old.\n\nDesign:\n\n* Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.\n* Participants will have between one and three visits.\n* Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.\n* Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.\n* The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.",[62,28,63,64,65],"Alcohol Dependence","Alcoholism","Alcohol Use Disorder","Addiction",[67,63,68,69,70,71,72],"fMRI","Phenotype","Imaging","EEG","Psychophysiology","Near Infrared",{"date":38,"type":39},{"date":75,"type":39},"2014-05-28",{"date":43,"type":22},{"name":45,"class":46},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":47},"100638177","reset-challenge-reducing-high-risk-drinking-for-cancer-prevention-100638177","NCT07591428","Reset Challenge: Reducing High-risk Drinking for Cancer Prevention","Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge","Inclusion Criteria:\n\n* Adults +18\n* Individuals who drink alcohol regularly\n* Further inclusion criteria will be determined via a Zoom screening with a member of the research staff.\n* Current Oklahoma Resident\n\nExclusion Criteria:\n\n\\- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.","120 Years",{"count":87,"type":22},150,[59],"This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.",[28,91,92],"Heavy Drinking","Binge Drinking",[94,95,96,97,98],"Daily drinking","Binge or Heavy Drinking","Dry January","Abstinence Challenge","30-day break","2026-06-24",{"date":101,"type":39},"2026-06-26",{"date":103,"type":39},"2026-06-10",{"date":105,"type":22},"2028-04",{"name":107,"class":108},"University of Oklahoma","OTHER",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100491146","effects-of-stereotype-threat-on-impulsivity-and-its-relation-to-alcohol-use-in-african-americans-an-fmri-study-100491146","NCT05675332","Effects of Stereotype Threat on Impulsivity and Its Relation to Alcohol Use in African Americans: An fMRI Study","Inclusion Criteria:\n\n* Between 21 and 35 years of age (inclusive);\n* Fluent in English;\n* Right-handed\n\nExclusion Criteria:\n\n* Younger than 21 years of age;\n* Left-handed","35 Years",{"count":117,"type":22},280,[59],"The purpose of this study is to investigate the behavioral and neural correlates of stress exposure. Results from this study will enrich the understanding of how sociocultural, behavioral, and neural factors combine to influence alcohol use.",[28],"2026-06-23",{"date":123,"type":39},"2026-06-25",{"date":125,"type":39},"2022-12-09",{"date":127,"type":22},"2027-01-31",{"name":129,"class":108},"Icahn School of Medicine at Mount Sinai",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":47},"100392576","covid-19-pandemic-impact-on-alcohol-pia---a-natural-history-study-100392576","NCT04391816","COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Participants who have enrolled in the NIAAA Natural History Protocol (14-AA-0181) and completed screening and phenotyping assessments.\n2. Willing and able to complete frequent (weekly to monthly) surveys either online or by phone.\n\nEXCLUSION CRITERIA:\n\nAs this is a natural history protocol, there are no formal exclusionary criteria for this study. Participants who are determined by the interviewer to be uncooperative or unable to provide consent via telephone will not be enrolled into the study.","100 Years",{"count":138,"type":22},1500,"OBSERVATIONAL","Background:\n\nThe SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time.\n\nObjective:\n\nTo study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder.\n\nEligibility:\n\nParticipants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181)\n\nDesign:\n\nParticipants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started.\n\nParticipants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey.\n\nParticipants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics:\n\n* Alcohol use and its consequences\n* Other substance use\n* Stress\n* Impact of the COVID-19 pandemic\n* Pain\n* Physical health\n* Sleep\n* Quality of life.\n\nBecause the course of the pandemic may change, the frequency of the surveys may change.\n\nParticipation lasts 2 years.",[28,142,143,144],"Alcohol-Related Disorders","Pandemic","Psychological Stress",[146,64,147,148,149,150],"Coronavirus","SARS-CoV2","Stress","Social Isolation","Natural History",{"date":99,"type":39},{"date":153,"type":39},"2020-06-03",{"date":43,"type":22},{"name":45,"class":46},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":47},"100217454","characterization-imaging-instruments-in-alcoholics-and-non-alcoholics-100217454","NCT02108080","Characterization Imaging Instruments in Alcoholics and Non-Alcoholics","Characterization Imaging Instruments for Addiction Neuroimaging Assessments","* INCLUSION CRITERIA:\n\nAll adult participants must be:\n\n* Age 18 years or older,\n* Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any\n\nNIAAA study (including 14-AA-0181).\n\nEXCLUSION CRITERIA:\n\nAs this is a natural history protocol, there are no exclusionary criteria for this study.\n\nParticipants should have been tested negative prior to the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be re-scheduled or withdrawn from the study.\n\nUpon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.\n\n-Exclusion criteria for MR scan\\*\n\n* Positive BrAC#,\n* Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, and opiates for outpatients. Positive UDT for benzodiazepines is not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes.\n* Task performance (behavioral, fMRI) only: cleared based on neuromotor examination,\n* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments),\n* Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner,\n* Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner,\n* Women: are pregnant#,\n* Are left-handed.\n* Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score \\> 8.\n\n  * Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.\n\n    * Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion.",{"count":164,"type":22},1000,"Background:\n\n\\- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA.\n\nObjective:\n\n\\- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.\n\nEligibility:\n\n\\- Adults age 18 and older.\n\nDesign:\n\n* Participants will visit the NIH Clinical Center once during the study.\n* Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview.\n* Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder.\n* Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner.\n* MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.",[62,28,142,63,167],"Brain Mapping",[169,170,171,68,69,150],"Alcohol","Biomarkers","Adults",{"date":99,"type":39},{"date":174,"type":39},"2014-07-10",{"date":43,"type":22},{"name":45,"class":46},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":47},"100644386","targeting-alcohol-opioid-co-use-among-young-adults-using-a-novel-mhealth-intervention-100644386","NCT07663448","Targeting Alcohol-Opioid Co-Use Among Young Adults Using a Novel MHealth Intervention","Inclusion Criteria:\n\n1. Ages 18 to 25 years, inclusive\n2. Self-report interest in reducing their alcohol-opioid co-use - outside a research study, people who do not wish to change their co-use are unlikely to download and use an mHealth app designed to reduce co-use. It is important to recruit participants who most closely resemble the intended users of the eventual mHealth intervention. This is defined as reporting any alcohol-opioid co-use goal (i.e., not selecting \"No goal\" in response to the alcohol-opioid co-use goal question at the screening visit).\n3. Self-report engaging in simultaneous alcohol-opioid co-use (i.e., use of both substances within two hours) ≥ 1 day\u002Fweek on average in the past 28 days (i.e., at least 4 co-use events in the past 28 days). This requirement will ensure that we observe sufficient use episodes where the pharmacological effects of alcohol and opioids overlap to evaluate project aims.\n4. Able to understand written and oral instructions in English, communicate understanding of the consent form, and provide written informed consent.\n5. Complete all assessments required at screening.\n6. Agree to the schedule of visits, verbally acknowledge that he\u002Fshe\u002Fthey will be able to attend each scheduled visit, participate in phone visits and that he\u002Fshe\u002Fthey does not have any already scheduled events or a job that may substantially interfere with study participation.\n7. Own a smartphone with data plan. Almost all participants (98%) in our preliminary work owned a smartphone with data plan.\n8. Currently reside in the United States of America.\n\nExclusion Criteria:\n\n1. Pregnant or nursing\n2. Current suicidality\n3. History of psychosis","25 Years",{"count":185,"type":22},30,[59],"The goal of this treatment development project is to develop and pilot an adaptive mobile health (mHealth) intervention that targets the co-use of alcohol and opioids in young adults.",[28,189],"Opioid Use","2026-06-17",{"date":121,"type":39},{"date":193,"type":39},"2026-06-08",{"date":195,"type":22},"2027-04-30",{"name":197,"class":108},"Brown University",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":47},"100540602","text-based-messaging-strategies-for-preventing-subsequent-problematic-alcohol-use-100540602","NCT06318975","Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use","The Effectiveness of Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use Among Technical Trainees in the US Air Force","Inclusion Criteria:\n\n* Must be a United States Air Force Technical Training student in one of the following training groups or wings: 37th Training Wing, 81st Training Wing, 82nd Training Wing, or 59th Training Group.\n* Must be 18 years of Age\n* Must be able to understand English\n* Must be able to receive text messages\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not in the specified Technical Training groups or wings",{"count":206,"type":22},7000,[59],"Binge drinking, and its health\u002Fsocial consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).\n\nBrief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.\n\nOne challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 7000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity.",[28,92,210],"Text Messaging",[212,213,214],"Military Population Health","Brief Alcohol Intervention","BAI",{"date":216,"type":39},"2026-06-15",{"date":218,"type":39},"2023-12-01",{"date":220,"type":22},"2028-12-31",{"name":222,"class":108},"University of Virginia",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":16,"sex":17,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":243,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":256,"locationsCount":47},"100479368","reducing-blood-pressure-in-mid-life-adult-binge-drinkers-100479368","NCT05522075","Reducing Blood Pressure in Mid-life Adult Binge Drinkers","Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity","Inclusion Criteria:\n\n* Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink\n* Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr).\n* Subjects who can speak and understand English.\n\nExclusion Criteria:\n\n* a history of diabetes, cardiovascular disease, liver, or renal disease\n* current or history of smoking and illicit drug use\n* blood pressure ≥160\u002F100 mm Hg\n* other known traditional cardiovascular disease risks: obesity (BMI≥35 kg\u002Fm2), or hyperlipidemia (total cholesterol\\>230 mg\u002Fdl and\u002For LDL cholesterol\\>160 mg\u002Fdl)\n* active infection (in the past 2 months)\n* a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)\n* unstable body weight (\\>5% change during the past 6 months)\n* regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)\n* current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)","50 Years","64 Years",{"count":233,"type":22},55,[59],"This study has two phases:\n\nPhase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers\u002Fmoderate drinkers.\n\nPhase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers",[28,92,237,238,239,240,241,242],"Blood Pressure","Alcohol Abstinence","Aging","Lifestyle Factors","Vasodilation","Behavioral Problem",[244,245,246,247,248,249],"Exercise training","High-intensity interval training","Midlife adults","Middle-aged","Microvascular function","Sympathetic nerve activity","2026-05-27",{"date":252,"type":39},"2026-06-01",{"date":254,"type":39},"2022-11-21",{"date":195,"type":22},{"name":257,"class":108},"The University of Texas at Arlington",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":266,"conditions":267,"keywords":274,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":47},"100557265","the-efficacy-of-conventional-screening-versus-mhealth-screening-in-early-detection-of-oral-potentially-malignant-disorders-and-oral-cancer-amongst-the-rural-population-of-varanasi-a-prospective-and-blinded-study-100557265","NCT06535867","The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study","Inclusion Criteria:\n\nPositive for any one or more of the following:\n\n* All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and\u002For regular use of alcohol)\n* Clinical signs\u002Fsymptoms (non-healing ulcers, white\u002F red\u002Fred \\& white patches in the mouth, restriction of mouth opening and swelling of the neck)\n* All individuals aged above 40 irrespective of habit\u002Foral lesions\n\nExclusion Criteria:\n\n* Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer\n* Under treatment for tuberculosis or suffering from any acute illness\u002F debilitating systemic disorders",{"count":265,"type":22},5122,"Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India",[34,268,269,270,271,272,28,273],"Smoking, Cigarette","Smoking, Tobacco","Betel Chewer's Mucosa","Tobacco Use","Tobacco Smoking","Smokeless Tobacco Hyperkeratosis",[275,276,277,278,279,280,281,282,283,284],"smoking","smoking, cigarette","smoking, tobacco","smokeless tobacco","betel leaf","areca nut","paan masala","alcohol use","Memorial Sloan Kettering Cancer Center","24-148","2026-05-19",{"date":287,"type":39},"2026-05-22",{"date":289,"type":39},"2024-07-30",{"date":291,"type":22},"2031-07-30",{"name":283,"class":108},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":183,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":313,"locationsCount":47},"100592556","multi-component-breath-alcohol-intervention-phase-3-100592556","NCT06994962","Multi-Component Breath Alcohol Intervention Phase 3","Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3","BAMTECH","1. Be between the ages of 18-25\n2. Be able to read English and complete study evaluations\n3. Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days\n4. Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.\n5. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)\n6. Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.\n\nExclusion Criteria\n\nNo subject may:\n\n1. Have been in inpatient or intensive outpatient treatment within the past 12 months\n2. Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months\n3. Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.\n4. History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.\n5. Be psychotic or otherwise severely psychiatrically disabled\n6. Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders).",{"count":302,"type":22},90,[59],"This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood\u002Fbreath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling\u002Fpsychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.",[31,28,306],"Drinking Behavior","2026-05-18",{"date":309,"type":39},"2026-05-20",{"date":311,"type":39},"2025-05-01",{"date":127,"type":22},{"name":314,"class":108},"Northeastern University",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":230,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":329,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":47},"100640797","effects-of-ketogenic-diet-on-alcohol-intoxication-100640797","NCT07602270","Effects of Ketogenic Diet on Alcohol Intoxication","Inclusion Criteria:\n\n1. Age 21 years to 50 years old.\n2. Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.\n2. Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.\n3. Currently taking medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified)\n4. Positive urine drug screen, positive for all substances but marijuana at screening or study visits (may be repeated once and if the result is negative on repeat, it is not exclusionary).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement, administration of ketogenic diet, or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).\n6. Currently suffering from or has a history of stroke and\u002For stroke related spasticity.\n7. Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture, inter-cranial bleeding or abnormal MRI (self-report, medical history).\n8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).\n9. Females who are pregnant or breast-feeding\n10. Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent subjects from lying comfortably flat on his\u002F her back for up to 2 hrs.",{"count":322,"type":22},20,[59],"The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \\~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +\u002F- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.",[326,28,64,327,328],"Ketogenic Diet","Magnetic Resonance Imaging","Alcohol Intoxication",[326,330],"Alcohol tolerance test","2026-05-15",{"date":287,"type":39},{"date":334,"type":39},"2026-05-14",{"date":336,"type":22},"2030-05",{"name":338,"class":108},"University of Pennsylvania",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":346,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":47},"100611316","clinical-effectiveness-of-a-motivational-interviewing-based-conversational-mobile-application-for-high-risk-drinkers-100611316","NCT07238998","Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers","Evaluating the Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers","Inclusion Criteria:\n\n1. Individuals aged 19 to 59 years who are capable of providing valid written informed consent.\n2. Individuals who meet the definition of high-risk drinking (AUDIT score ≥ 8).3.- Individuals who express a desire to reduce their alcohol consumption.\n3. Individuals who own and use an Android smartphone (version 8 or higher).\n4. Individuals who have no difficulty using mobile applications.\n5. Individuals who are able to communicate adequately with the research team.\n6. Individuals who fully understand the study procedures and voluntarily agree to participate.\n\nExclusion Criteria:\n\n1. Individuals who are unable to read or understand the consent form (e.g., illiterate individuals, non-Korean speakers).\n2. Individuals with impaired decision-making capacity.\n3. Pregnant individuals or those planning to become pregnant during the study period.\n4. Individuals who are currently participating in another clinical study.\n5. Individuals who are receiving treatment or counseling for alcohol-related problems.\n6. Individuals who use two or more mobile phones.\n7. Individuals who are expected to change their mobile phone or SIM card, or who plan to travel 8. abroad during the intervention period.\n8. Any individual deemed inappropriate for study participation at the discretion of the investigator.","19 Years","59 Years",{"count":349,"type":22},220,[59],"This study aims to evaluate and compare the degree of alcohol reduction between high-risk drinkers who use a motivational interviewing-based conversational agent (chatbot) application for four weeks and those in the control group who do not use the application, in order to verify its clinical effectiveness.",[28,353],"High-Risk Drinking Patterns","2026-05-11",{"date":356,"type":39},"2026-05-13",{"date":358,"type":39},"2025-12-19",{"date":360,"type":22},"2027-04",{"name":362,"class":108},"Yonsei University",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":380,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":47},"100637977","acute-effects-of-jgermeister-with-energy-drinks-jgermbomb-100637977","NCT07588022","Acute Effects of Jägermeister With Energy Drinks (Jägermbomb)","Acute Effects of an Explosive Cocktail With Energy Drinks That is Trendy Among Young People, the Jägerbomb","JB","Inclusion Criteria:\n\n1. Men and women between 18-45 years old with a weight between 50-90 kg for men and between 55-80 kg for women, and a body mass index (BMI) between 19-28 kg\u002Fm2. Lower or higher weights or BMIs are allowed, in the opinion of the Principal Investigator or the collaborators designated by the Principal Investigator and that do not pose a risk to the subjects and do not interfere with the objectives of the study.\n2. Alcohol consumption in the form of occasional binge drinking (≥1 time\u002Fmonth), social alcohol consumption (≥10g\u002Fday distributed weekly) and experience in alcohol intoxication.\n3. Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.\n4. Understand and agree to the trial procedures and sign an informed consent.\n5. History and physical examination that demonstrate no organic or psychiatric disorders.\n6. The ECG and general blood and urine tests performed before the test should be within normal limits. Minor or punctual variations from the limits of normality are allowed if, at the discretion of the Principal Investigator, taking into account the state of science, they are not of clinical significance, do not pose a risk to the subjects and do not interfere with the assessment of the product. These variations and their non-relevance will be justified in writing in a specific way.\n\nExclusion Criteria:\n\n1. Not meeting the inclusion criteria.\n2. History or clinical evidence of gastrointestinal, liver, renal or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.\n3. Current history of substance use disorder according to DSM-V (except nicotine). A previous history of mild substance use disorder (corresponding to substance abuse according to DSM-IV criteria) is admitted.\n4. History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.\n5. Have participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks.\n\n5\\) Have suffered any organic disease or major surgery in the three months prior to the start of the study.\n\n6\\) Subjects who have an intolerance or have had serious adverse reactions to alcohol. The inclusion of subjects of oriental origin who do not have an intolerance to alcohol will be allowed.\n\n7\\) Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies, or dietary supplements that, in the judgment of the Principal Investigator or collaborators designated by the Principal Investigator, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to study sessions will not be grounds for exclusion if it is assumed to have been completely eliminated on the day of the experimental session.\n\n8\\) Smokers of \\>5 cigarettes a day. 9) Consumption of more than 20 g of alcohol daily in women and more than 40 g in men.\n\n10\\) Consumers of more than 5 coffees, teas, colas, or other stimulant or xanthine beverages daily in the 3 months prior to the start of the study.\n\n11\\) Subjects who are not able to understand the nature of the trial and the procedures they are asked to follow.\n\n12\\) Subjects with positive serology for hepatitis B, C or HIV. 13) Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).\n\n14\\) Women with amenorrhea or premenstrual syndrome of severe intensity.","45 Years",{"count":373,"type":22},24,[59],"The main objective of this study is to compare the acute effects of drinking Jägerbombs with drinking alcohol alone during a binge-drinking episode, which involves consuming a large amount of alcohol in a short period of time to become intoxicated. Secondary objectives are to assess whether Jägerbombs produce prototypical alcohol effects, increase stimulation and rewarding effects, affect coordination, time reaction and vision, change stress-related hormone responses, and cause hangover symptoms.",[28,377,378,379],"Healthy Adult Participants","Binge Alcohol Consumption","Energy Drinks",[381,382,169,383],"Binge drinking","Jägerbomb","Psychomotor performance","2026-05-08",{"date":334,"type":39},{"date":387,"type":39},"2026-02-18",{"date":389,"type":22},"2027-06",{"name":391,"class":108},"Fundació Institut Germans Trias i Pujol",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":407,"overallStatus":409,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100548538","developing-and-testing-an-online-intervention-for-alcohol-and-cannabis-misuse-and-healthy-relationship-skills-among-young-adult-couples-100548538","NCT06422299","Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples","Developing and Testing an Online Intervention for Decreasing Alcohol and Cannabis Misuse and Increasing Healthy Relationship Skills Among Young Adult Couples: A Comprehensive Mixed-methods Approach","Inclusion Criteria:\n\n* Both partners in the couple are 18-29 years old\n* In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months\n* Face-to-face contact their partner at least 5 days per week\n* Live in Washington State\n* Have a valid email address and access to a cell phone\n* Report alcohol and cannabis co-use at least three times in the past month\n* Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner\n\nExclusion Criteria:\n\n* Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources","29 Years",{"count":401,"type":22},60,[59],"The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are:\n\n* Will the intervention be feasible and acceptable to young adult couples?\n* Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning?\n\nEligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up.\n\nResearchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.",[28,405,406],"Cannabis Use","Couples",[408],"alcohol use, cannabis use, couples, healthy relationships, young adults","NOT_YET_RECRUITING","2026-05-04",{"date":412,"type":39},"2026-05-06",{"date":414,"type":22},"2026-09-15",{"date":416,"type":22},"2027-08-01",{"name":418,"class":108},"University of Washington",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":433,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":47},"100486831","a-smart-evaluation-of-an-adaptive-web-based-aud-treatment-for-service-members-and-their-partners-100486831","NCT05619185","A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners","Inclusion Criteria:\n\n* at least 18 years of age;\n* be living together with their partner, with no plans to change that status in the next 2 months;\n* not be in the military themselves (to reduce concerns about mandated reporting of alcohol use);\n* score ≥4 on the AUDIT-C for females or ≥5 for males\u002Fother;\n* respond yes to \"Do you feel safe in your current relationship?\" from the Partner Violence Screen;\n* report not currently being in mental health or alcohol treatment (CP and SM)\n* understand English fluently,\n* be willing to try an online program to address risky drinking.\n\nWe require cohabitating CPs and SMs with no anticipated changes in the next two months to ensure close contact and opportunity to practice new skills, and those who would feel safe participating.\n\nExclusion Criteria:\n\n* CPs in substance use treatment or their SM was in treatment in the last three months;\n* does not feel safe in the current relationship;\n* does not understand English fluently;\n* has an impaired capacity (cognitive, visual, or hearing);\n* is not cohabitating with their SM",{"count":426,"type":22},744,[59],"The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.",[430,64,28,431,432],"Alcohol Abuse","Relations, Interpersonal","Military Family",[434,435,436,437],"military","alcohol","drinking","substance use","2026-04-22",{"date":440,"type":39},"2026-04-27",{"date":442,"type":39},"2024-06-14",{"date":444,"type":22},"2027-08-31",{"name":446,"class":108},"Stanford University",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":455,"minAge":54,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":47},"100422880","alcohol-self-reporting-during-pregnancy-autoquest-study-100422880","NCT04786587","Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.","Evaluation of the Diagnostic Value of the Self-report T-ACE for Screening of High-risk Alcohol Consumption During Pregnancy : Comparison With the Dosage of a Blood Biomarker Used as Gold Standard. AUTOQUEST Study.","AUTOQUEST","Inclusion Criteria:\n\n* pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care\n* and having returned her self-report\n* and having given her written consent\n* no exclusion criteria\n\nExclusion Criteria:\n\n* woman under 18 years old\n* or not pregnant\n* or not having returned her self-report\n* or woman who refused to participate in the study (absence of written consent)","FEMALE",{"count":457,"type":22},2425,"The effects of alcohol consumption during pregnancy have been known for decades. However, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. During pregnancy, standardized self-reports such as T-ACE would help identify early women with high-risk alcohol consumption. T-ACE appears to be one of the most used during pregnancy but its diagnostic value is not objectively known.\n\nTo evaluate the diagnostic value of T-ACE self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood.\n\nMaterial and methods Multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of North of France. The self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. When they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. Made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of T-ACE. An alcohol consumption will be considered \" at high risk \" if blood phosphatidylethanol is ≥ 20 µg\u002FL.\n\nWith a predictable 25% rejection rate and a positive 4% T-ACE frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of T-ACE with a satisfactory 95% confidence interval in this population.\n\nThe evidence of a link between positive T-ACE and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy.\n\nThe T-ACE within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the North of France is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. If T-ACE appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.",[28,460],"Pregnancy",[462,463,464,465],"screening","alcohol consumption","pregnancy","self report","2026-04-21",{"date":438,"type":39},{"date":469,"type":39},"2024-04-08",{"date":360,"type":22},{"name":472,"class":108},"University Hospital, Lille",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":183,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":47},"100506363","motivations-attitudes-and-perceptions-study-100506363","NCT05873413","Motivations, Attitudes, and Perceptions Study","RCT of a Combined MI Intervention to Address Bystander Behaviors in the Context of Alcohol Use","MAP","Inclusion Criteria:\n\n* Individuals ages 18-25\n* Heavy drinkers (as defined by using the AUDIT)\n* English fluency\n* Community members from Lancaster and surrounding counties in Nebraska\n* Signed and dated consent form\n* Stated willingness to comply with study procedures\n\nExclusion Criteria: This project does not have any pre-determined exclusion criteria beyond the need to meet inclusion criteria for the study.",{"count":482,"type":22},450,[59],"The goal of this clinical trial is to compare the impact of providing participants with\n\n1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone\n2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol)\n3. A control condition focused on reducing stress\n\nThe main questions it aims to answer are:\n\n* Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors?\n* Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors?\n* Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities?\n\nParticipants will:\n\n* Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors)\n* Complete either MTB, MTB+ALC, or the attention control condition online\n* Complete the virtual reality simulation in the lab\n* Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention",[28,486,487],"Sexual Violence","Social Norms","2026-04-20",{"date":438,"type":39},{"date":491,"type":39},"2024-03-01",{"date":493,"type":22},"2026-05-31",{"name":495,"class":108},"University of Nebraska Lincoln",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":47},"100516293","approach-avoidance-and-alcohol-challenge-study-in-ptsd-100516293","NCT06002633","Approach-Avoidance and Alcohol Challenge Study in PTSD","Alcohol, Approach-Avoidance, and Neurocircuitry Interactions in PTSD","PACS","1. Inclusion criteria for all participants:\n\n   * between 21 and 60 years of age\n   * having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year\n2. Inclusion criteria for PTSD participants:\n\n   \\- Meeting diagnostic criteria for PTSD, confirmed by structured interview\n3. For all subjects exclusion criteria include:\n\n   * history of significant medical illness, particularly if possible changes in cerebral tissue\n   * neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)\n   * full Scale IQ \\\u003C85\n   * contraindication to MRI scanning\n   * positive pregnancy test\n   * severe alcohol use disorder\n   * current severe cannabis use disorder\n   * any current substance use disorder (other than alcohol, cannabis, or nicotine)\n   * scores \\> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)\n   * ever being in an abstinence-oriented treatment program for alcohol use\n   * reporting wanting to quit drinking but not being able to\n   * any medical, religious, or other reasons for not drinking alcohol\n   * history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease\n   * an adverse reaction to alcoholic beverages\n   * reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year\n   * unwillingness to have a friend or family member drive them home after the alcohol administration sessions\n4. Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:\n\n   * not taking medications for \\>4 weeks (i.e. participants must be stable on meds)\n   * acute suicidality with intent\n5. Additional exclusion criteria for participants in IPV-exposure but no PTSD group:\n\n   \\- history of PTSD\n6. Additional exclusion criteria for healthy comparison subjects also include:\n\n   * any prior psychiatric hospitalizations\n   * lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder\n   * greater than 1 month of lifetime psychotropic medication",{"count":505,"type":22},200,[59],"Individuals with posttraumatic stress disorder (PTSD) have greater prevalence of alcohol use disorders (AUDs), with this comorbidity associated with worse illness outcomes, yet there remains limited mechanistic understanding of how PTSD confers risk for AUD. Understanding risk factors that associate with and predict the development of AUDs in PTSD could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in PTSD aimed at capturing the mechanisms leading to the emergence of AUDs. There is growing evidence PTSD is related to biased decision-making during approach-avoidance conflict. Alcohol is also suggested to alter approach-avoidance decision-making. AUDs and acute alcohol intoxication is associated with a bias to seek out reward despite the possibility of threat (e.g., contributing to relapse following alcohol cue exposure and risky behavior during intoxication respectively). Alcohol-induced changes in approach-avoidance decision-making have not been investigated in the context of PTSD, but emerging data support the investigators' hypothesis that an interaction between alcohol and approach-avoidance conflict in PTSD may occur and contribute to risk for alcohol misuse and development of alcohol problems. No current data, cross-sectional or longitudinal, have tested the role of alcohol-induced changes in approach-avoidance conflict as a mechanism of risk for AUD among individuals with PTSD. To address this gap, the investigators propose to leverage the group's expertise in placebo-controlled alcohol administration procedures, longitudinal modeling, functional neuroimaging, and computational neuroscience approaches to investigate the effects of acute alcohol on approach-avoidance decision-making and mediating changes in multivariate neurocircuitry patterns in limbic, striatal, and salience networks.",[509,28],"Post-Traumatic Stress Disorder","2026-04-10",{"date":512,"type":39},"2026-04-15",{"date":514,"type":39},"2023-10-23",{"date":516,"type":22},"2028-05-31",{"name":518,"class":108},"University of Texas at Austin",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":455,"minAge":54,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":47},"100498169","reducing-alcohol-exposed-pregnancies-100498169","NCT05766761","Reducing Alcohol Exposed Pregnancies","Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies","Inclusion Criteria:\n\n* 18 years and above\n* Gestational age is 28 weeks or less\n* Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not pregnant or gestational age over 28 weeks\n* No recent alcohol use as assessed by self-report",{"count":527,"type":22},600,[59],"The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can:\n\n1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and\n2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.",[28],[532,533,534],"alcohol drinking in pregnancy","alcohol-exposed pregnancies","alcohol-related adverse birth outcomes","2026-04-08",{"date":537,"type":39},"2026-04-13",{"date":539,"type":39},"2024-04-15",{"date":195,"type":22},{"name":542,"class":108},"New York University",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":557,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":47},"100439178","mpfc-theta-burst-stimulation-as-a-treatment-tool-for-alcohol-use-disorder-effects-on-drinking-and-incentive-salience-100439178","NCT04998916","MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience","Inclusion Criteria:\n\n* Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction)\n* Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V\n* Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.\n* Able to read and understand questionnaires and informed consent.\n\nExclusion Criteria:\n\n* Has metal placed above the neck\n* Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)\n* Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal\n* Has a history of claustrophobia\n* Has a history of chronic migraines\n* Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage\n* Has an unstable medical illness requiring planned medical\u002Fsurgical intervention (e.g. chemotherapy, surgical procedure)\n* Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric\u002Fsleeping medications except for stable (1 month) antidepressants\u002FSSRI's. \\[Note: this criterion is for scientific rather than safety or patient comfort reasons\\].\n* Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months\n* Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \\[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\\]\n* Has current suicidal ideation or homicidal ideation\n* Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.",{"count":550,"type":22},86,[59],"The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.",[64,28,554,555,556],"Substance Use","Drinking, Alcohol","Alcohol Use Disorder (AUD)",[558,559,560,561,562],"Transcranial Magnetic Stimulation","Medial Prefrontal Cortex","Brain Stimulation","Non-invasive","Adult","2026-03-27",{"date":565,"type":39},"2026-04-02",{"date":567,"type":39},"2021-07-06",{"date":43,"type":22},{"name":570,"class":108},"Medical University of South Carolina",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":582,"conditions":583,"keywords":586,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":47},"100578741","phase-2-effects-of-ketone-supplement-and-alcohol-on-brain-metabolism-100578741","NCT06815237","Effects of Ketone Supplement and Alcohol on Brain Metabolism","Acute Effects of Ketone Supplementation and Alcohol on Brain Metabolism","Inclusion Criteria:\n\n1. Able to provide written informed consent and commit to completing study procedures.\n2. Reported on at least one day in the month before consent of consuming 2 or more standard alcoholic drinks on a single day.\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from the use of psychoactive medications, medication that may affect study results, and or alcohol, within 24 hours of the Alcohol lab, and MRI procedures (self-report, medical history, UDS, and breathalyzer).\n2. Current DSM-5 diagnosis of a major psychiatric disorder (other than marijuana and nicotine use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.\n3. Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; psychotropic drugs not otherwise specified)\n4. Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).\n6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.\n7. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).\n8. Pregnant or breast-feeding\n9. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).\n10. Self-reported claustrophobia\n11. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).",{"count":401,"type":22},[580,581],"PHASE2","PHASE3","The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention. These interventions will be randomly assigned (meaning everyone receives all 3 interventions, but in different orders).",[584,28,585],"Ketosis","MRI",[587],"ketone supplement","2026-03-23",{"date":590,"type":39},"2026-03-25",{"date":592,"type":39},"2025-05-13",{"date":594,"type":22},"2029-05-31",{"name":338,"class":108},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":604,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":612,"overallStatus":409,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":47},"100628525","phase-1-precision-microbiota-interventions-for-senoreduction-trial-100628525","NCT07462767","Precision Microbiota Interventions for Senoreduction Trial","Geroprotective Precision Medicine Strategies in PWH That Use Alcohol","PreMIS","Inclusion Criteria:\n\n* Age ≥40 years\n* People with HIV\n* Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)\n\nExclusion Criteria:\n\n* Probiotic use in past 3 months\n* Recent antibiotics or immunosuppressives\n* Allergy to study products\n* Pregnancy or breastfeeding\n* Inability to comply","40 Years",{"count":606,"type":22},160,[25,580],"People with HIV who drink alcohol are at increased risk for accelerated aging biology, including increased immune senescence. This randomized, double-blind, crossover clinical trial evaluates two generally recognized as safe (GRAS) microbiota-targeted interventions on immune senescence biomarkers.",[610,28,239,611],"HIV Infections","Immunosenescence",[613,614,611,615,616,617,618,619],"People with HIV","Alcohol use","Senescence","Microbiome","Probiotic","Blueberry extract","Crossover trial","2026-03-05",{"date":622,"type":39},"2026-03-10",{"date":624,"type":22},"2026-04-01",{"date":626,"type":22},"2029-12-01",{"name":628,"class":108},"Louisiana State University Health Sciences Center in New Orleans",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":409,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":4},"100504382","mhealth-supported-skills-training-for-alcohol-related-suicidality-phase-3-100504382","NCT05847582","mHealth-supported Skills Training for Alcohol-Related Suicidality Phase 3","Pilot RCT to Evaluate Feasibility and Acceptability of mSTARS","mSTARS","Inclusion Criteria:\n\n* Age 18+\n* hospitalized for suicide crisis at Duke BHIP\n* an AUDIT-C score indicating hazardous past-month drinking (4 for men; 3 for women) + a 90-day calendar timeline follow-back (TLFB) indicating a minimum of 3 heavy drinking days per week on average (per NIAAA standards)\n* owns a smart phone\n* fluent in English.\n\nExclusion Criteria:\n\n* current psychotic or mania symptoms indicated by the MINI Neuropsychiatric Interview 6.0.(MINI)\n* receiving ECT at the time of hospitalization, which could inhibit learning\n* engaged in weekly outpatient psychotherapy\n* discharging to another high level of psychiatric care.",{"count":638,"type":22},35,[59],"Suicide is a high priority public health problem and an increasingly prevalent alcohol-related consequence. One-third of people who die by suicide consume alcohol at hazardous rates in the year preceding death. Most people in an acute suicide crisis who present for treatment are admitted to acute psychiatric hospitalization. Yet, the 30-day period following discharge from hospitalization is by far the riskiest period for another suicide crisis. The specific aim for this project is to evaluate the feasibility and acceptability of an intervention called mHealth-supported Skills Training for Alcohol-Related Suicidality (mSTARS). Thirty-five inpatients with suicidal thoughts or behaviors who misuse alcohol will be randomized to one of three study conditions -- mSTARS, treatment as usual, or treatment as usual with skills training.",[28,642],"Suicide",{"date":644,"type":39},"2026-03-09",{"date":646,"type":22},"2026-08-01",{"date":648,"type":22},"2027-12-31",{"name":650,"class":108},"Duke University",{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":658,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":47},"100624905","the-glucid-study-effect-of-alcohol-reduction-and-probiotic-interventions-on-cognition-and-brain-glucose-metabolism-in-normal-aging-adults-who-are-high-risk-alcohol-drinkers-100624905","NCT07415707","The GLUCID Study: Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers","Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers","Inclusion Criteria:\n\n* Between 65 and 84 years of age\n* English speaking\n* Able to provide valid informed consent, understand requirement and risk\u002Fbenefits of the study and comply with study protocol\n* Heavy drinker defined as \\>14 alcoholic drinks\u002Fweek for men and \\>7 drinks\u002Fweek for women\n* Interested in reducing their alcohol consumption\n\nExclusion Criteria:\n\n* BMI ≥ 35\n* Fasting Glucose \\> 125 mg\u002FdL\n* Current or previously diagnosed with Type 1 or 2 Diabetes\n* Requires the use of insulin and\u002For other glucose lowering agents\n* Unable to fast for 12 hours\n* Past serious alcohol withdrawal symptoms\n* MRI Contraindications (e.g., certain devices and implants, claustrophobic)\n* Diagnosed with a neurodegenerative disease (e.g., Alzheimer's Disease)\n* Diagnosed with a psychotic disorder\n* Current substance dependence diagnosis (except for mild or moderate alcohol)\n* Consumption of over 300 drinks in the past 30 days\n* Current probiotic use or recent probiotic use within the past 30 days\n* Current antibiotic use or recent antibiotic use within the past 30 days\n* In active cancer treatment and\u002For have advanced cancer\n* Taking daily steroids and\u002For immunosuppressants\n* Lifetime organ or bone marrow transplant; primary immunodeficiency (e.g., DiGeorge syndrome or Wiskott-Aldrich syndrome) or transplant recipient or prescribed immunosuppressant medications\n* PI's discretion","84 Years",{"count":322,"type":22},[59],"The goal of this pilot study is to explore a combination of two interventions: (1) a behavioral alcohol-reduction intervention using motivational interviewing, and (2) a blinded probiotic microbiome or placebo intervention. The study examines whether these interventions improve cognitive and neurophysiological function, including brain metabolism, in older adults who are high-risk alcohol drinkers.",[239,28],"2026-03-03",{"date":665,"type":39},"2026-03-04",{"date":667,"type":39},"2026-02-26",{"date":195,"type":22},{"name":670,"class":108},"University of Miami"]