[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute on Alcohol Abuse and Alcoholism (NIAAA)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":402},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,77,105,132,151,172,192,217,241,265,284,305,326,351,379],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"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},"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":20,"type":21},128,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Alcohol Drinking",[29,30,31,32,33],"Functional Magnetic Resonance Imaging (fMRI)","Alcohol Use","Polymorphism, Genetic","Magnetic Resonance Imaging (MRI)","Smoking","RECRUITING","2026-06-27",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2019-06-10",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":46},"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":56,"type":21},400,[58],"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.",[61,27,62,63,64],"Alcohol Dependence","Alcoholism","Alcohol Use Disorder","Addiction",[66,62,67,68,69,70,71],"fMRI","Phenotype","Imaging","EEG","Psychophysiology","Near Infrared",{"date":37,"type":38},{"date":74,"type":38},"2014-05-28",{"date":42,"type":21},{"name":44,"class":45},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":46},"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":85,"type":21},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.",[27,89,90,91],"Alcohol-Related Disorders","Pandemic","Psychological Stress",[93,63,94,95,96,97],"Coronavirus","SARS-CoV2","Stress","Social Isolation","Natural History","2026-06-23",{"date":100,"type":38},"2026-06-24",{"date":102,"type":38},"2020-06-03",{"date":42,"type":21},{"name":44,"class":45},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":15,"sex":111,"minAge":53,"maxAge":18,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":46},"100317012","phase-2-effects-of-sucralose-on-drug-absorption-and-metabolism-the-sweetmeds-study-100317012","NCT03407079","Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)","* INCLUSION CRITERIA:\n\n  1. Age: between 18 and 60 years\n  2. Female adults who self-identify as Hispanic and\u002For Black\n  3. Body weight greater than 50 kg (110 lb)\n  4. Body mass index between 25 kg\u002Fm\\^2 and 40 kg\u002Fm\\^2\n  5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent\n  6. Healthy with no known active medical condition or illness that requires drug treatment\n  7. Able and willing to consume approximately 4 mg\u002Fkg sucralose daily or placebo in form of capsules for\n\n  4 weeks\n\n  8\\. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study\n\n  9\\. Able and willing to collect stool specimens\n\n  10\\. Able and willing to consume digoxin and midazolam during study visits\n\nEXCLUSION CRITERIA:\n\n1. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators.\n2. Diabetes (fasting blood glucose of 126 mg\u002Fdl or higher, or 2-hour blood glucose of 200 or higher on OGTT)\n3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics\n4. GI history, at the discretion of the investigators\n5. Known allergy, sensitivity, or other contraindication to study procedures\n6. ALT or AST more than 1.5 times the upper limit of normal\n7. Abnormal thyroid function or abnormal serum electrolytes \\& minerals (specifically potassium, calcium, and magnesium)\n8. Narrow angle glaucoma or untreated open angle glaucoma\n9. Regular use of alcohol (more than 1 drink per day) or drug use\n10. History of cardiac abnormalities, especially arrhythmia\n11. Unable or unwilling to cooperate with study procedures\n12. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures\n13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).","FEMALE",{"count":113,"type":21},150,[115],"PHASE2","Background:\n\nArtificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.\n\nObjective:\n\nTo see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.\n\nEligibility:\n\nPeople ages 18-60 who:\n\n* Are black or Hispanic\n* Weigh more than 110 pounds\n* Have a body mass index of 25-40\n* Do not have a condition that requires drug treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, heart, and urine tests\n\nParticipants must not eat or drink anything with artificial sweeteners throughout the study.\n\nOver 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.\n\nOvernight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:\n\n* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.\n* A piece of fat tissue may be taken from the abdomen (biopsy).\n* Participants will have a sweet drink. Blood samples will be taken over 2 hours.\n\nThen participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.\n\nOvernight Visit 2 repeats Visit 1 except the biopsy.\n\nThen participants will take the capsules for another 2 weeks.\n\nOvernight Visit 3 repeats Visit 1.\n\nParticipants may be contacted by phone within 4 weeks after they finish.",[118,119],"Healthy Volunteers","Overweight",[121,122,123,124,125],"Drug Metabolism","Artificial Sweetener","P-Glycoprotein","Cytochrome P450","Microbiome",{"date":100,"type":38},{"date":128,"type":38},"2018-04-05",{"date":130,"type":21},"2027-12-26",{"name":44,"class":45},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":46},"100250204","development-of-neuroimaging-methods-to-assess-the-neurobiology-of-addiction-100250204","NCT02535702","Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction","Development of Neuroimaging Methods to Assess the Neurobiology of Addiction","* INCLUSION CRITERIA:\n\n  1. Eighteen years or older.\n  2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent.\n  3. Willingness to abstain from drug use on scheduled testing days.\n\nEXCLUSION CRITERIA\n\n1. Positive urine pregnancy test in females.\n2. 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) or fear of enclosed spaces as determined by the self-report checklist.\n3. Claustrophobia.\n4. Body weight \\>550 lbs, which is the weight limit of the MR scanner.\n5. Current DSM-5 diagnosis of a psychiatric disorder (other than nicotine\u002Fcaffeine use disorders) as determined by history and clinical exam including substance use disorder, alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it was severe enough as to require hospitalization (any length), or chronic medication management (more than 4 weeks), or that could impact brain function at the time of the study. Subjects receiving psychotherapy may be included in the study.\n6. Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month.\n7. Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy.\n8. Currently taking any psychoactive drugs such as Celexa (TM), Prozac (TM), Wellbutrin (TM), Zoloft (TM), and\u002For stimulants other than caffeine such as Adderall (TM), Dexedrine (TM) and Ritalin (TM). Subjects taking PRN medications (e.g., sleep medications) may be included in the study.\n9. Clinically significant laboratory or examination results.\n10. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).\n11. \\*Non-English speakers (must also be able to read and comprehend English).\n\n    * The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since our fMRI paradigms (particularly the Delay Discounting task) require that the subject be able to speak, read and comprehend English.\n\nSubjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. However, if they test positive on scheduled study procedure days involving MRI, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug or BAL screens. If the drug\u002FBAL tests is\u002Fare positive on the third rescheduled visit, the participant will be withdrawn from the study.",{"count":140,"type":21},192,[58],"Background:\n\nAbusing alcohol, drugs, and other substances can cause serious health problems. These substances also can affect brain function. Researchers want to learn more about brain function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio waves to take pictures of the brain.\n\nObjective:\n\nTo develop new ways to use MRI to study the brain.\n\nEligibility:\n\nHealthy people 18 years of age or older.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood and urine tests.\n\nThey will answer questions about their drug use and psychiatric history. They will be asked about family history of alcoholism or drug abuse.\n\nParticipants will answer questions to see if they can participate in MRI.\n\nParticipants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil may be placed over the head.\n\nEach sub-study will include up to 3 different MRI visits. Participants can be in multiple sub-studies. But they can have only 1 MRI per week and 20 per year.\n\nDuring MRI visits, participants may have urine collected. They may get another MRI questionnaire.\n\nParticipants may have a clinical MRI brain scan. This may show physical problems in the brain.\n\nDuring some scans, participants may perform simple movement, memory, and thinking tasks.\n\nParticipants may be connected to a machine to monitor brain activity during the scan. Small metal electrodes will be placed on the scalp. A gel will be placed in the space between the electrodes and the scalp.",[144],"Normal Physiology",[66,69],{"date":100,"type":38},{"date":148,"type":38},"2016-06-28",{"date":42,"type":21},{"name":44,"class":45},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":46},"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":159,"type":21},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.",[61,27,89,62,162],"Brain Mapping",[164,165,166,67,68,97],"Alcohol","Biomarkers","Adults",{"date":100,"type":38},{"date":169,"type":38},"2014-07-10",{"date":42,"type":21},{"name":44,"class":45},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":83,"enrollmentInfo":178,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":46},"100226932","niaaa-natural-history-protocol-100226932","NCT02231840","NIAAA Natural History Protocol","* INCLUSION CRITERIA:\n\nAs this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:\n\n* Age \\>=18 years of age\n* Willingness to complete the study including genetic and MRI tests.\n\nWe will assign participants to one of two groups in this study:\n\n* Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and\n* Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).\n\nAll participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility.\n\nEXCLUSION CRITERIA:\n\nThis is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:\n\n* Individuals \\\u003C 18 years of age\n* Prisoners\n* Pregnant candidates\n* Candidates having a severe medical or mental health disorder that would impair participation in the study\n\nAll participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study.",{"count":179,"type":21},7500,"Background:\n\n\\- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.\n\nObjective:\n\n-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.\n\nEligibility:\n\n* Adults age 18 and older.\n* Not being pregnant or imprisoned.\n\nDesign:\n\n* Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.\n* Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.\n* Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.\n* Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.\n* After discharge, participants may be called and asked questions about their drinking and health.\n* If participants sign the second consent, they:\n* will complete paper- and computer-based questionnaires.\n* will give blood samples.\n* may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.",[63],[183,184,63,97],"Phenotypes","Genetics","2026-06-19",{"date":98,"type":38},{"date":188,"type":38},"2015-01-21",{"date":190,"type":21},"2044-12-31",{"name":44,"class":45},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":46},"100635962","phase-1-tirzepatide-s-dopaminergic-effects-in-alcohol-use-disorders-aud-100635962","NCT07559500","Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)","Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD), a Phase 1b Study","* INCLUSION CRITERIA:\n\nHealthy Volunteer Participants\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n\nAUD Participants\n\nTo be eligible, individuals with AUD must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. DSM 5 diagnosis of mild to moderate AUD.\n6. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n7. Minimum 2-year history of heavy drinking (SAMSHA s criteria for heavy drinking: for men 5 or more drinks\u002Fday on at least 5 different days per month; and for women 4 or more\n\n   drinks\u002Fday on at least 5 different days per month.\n8. Non treatment seeking AUD participants.\n\nEXCLUSION CRITERIA:\n\nAll Participants (Healthy Volunteers and AUD)\n\n1. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI\n2. Cannot lie comfortably flat on his\u002Fher back for up to 2 hours in the PET\u002FMRI scanner.\n3. BMI \\\u003C23 or \\>35 (but no more than 500 lbs). The PET\u002FMRI scanner bed is tested to a weight limit of 500 lbs.\n4. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n5. Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n6. Women using oral contraceptives (Part 2 of study). Women of childbearing age who are taking oral contraceptives will be required to switch to a non-oral hormonal contraceptive method (ie implants, injections, or IUDs) or add a barrier method (condoms) for the duration of the study and for 4 weeks after the last dose of study drug after explaining to them that Tirzepatide could make contraceptive less effective. We will not provide nonoral contraceptive medications to participants.\n7. Severe head trauma with loss of consciousness \\> 60 minutes\n8. Current severe mental illness (schizophrenia, bipolar disorder).\n9. Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or suicidal thoughts item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n10. Thyroid cancer or family history of thyroid cancer or personal or family history of multiple endocrine neoplasia syndrome type-2 (MEN-2).\n11. History for cerebral aneurysm.\n12. Past or present history of chest pain and trouble breathing with activity.\n13. History of Heart Disease, Hypertension or Cardiovascular disorders.\n14. History of seizures, anxiety, panic attacks, psychosis or glaucoma which are contraindicated with receiving methylphenidate.\n15. History of gallbladder disease, pancreatitis, gastroparesis, diabetic retinopathy, acute kidney injury (AKI), as these are contraindicated for Tirzepatide.\n16. History of allergic reaction to methylphenidate, Tirzepatide or allergic reactions to dyes or preservatives.\n17. Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer s disease, Parkinson s disease, traumatic brain injury with\n\n    loss of consciousness \\> 30 minutes, clinically significant arrhythmias except bradycardia, and HIV+).\n18. Clinically significant laboratory findings that could impact brain function or study procedures (e.g., active infections, significant EKG results, hepatic or renal failure) will be\n\n    exclusionary.\n19. Current DSM-5 diagnosis of a psychiatric disorder that required daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n20. History of moderate or severe SUD (other than nicotine or alcohol for AUD participants).\n21. Current severe depression or moderate\u002Fsevere suicidal ideation.\n22. Daily current use (past 2 months) of the following drugs\u002Fmedications are exclusionary: stimulant or stimulant-like drugs or medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; other GLP-1 or anti-diabetic drugs (e.g., insulin, sulfonylureas) medications, antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants with dopaminergic effects (bupropion, sertraline, and dopamine agonists like pramipexole and ropinirole); beta-blocker antihypertensives; antineoplastics; antipsychotics; anxiolytics (benzodiazepine or barbiturates); or lithium. Note that alcohol and cannabis use are not exclusionary but participants cannot be intoxicated on the day of study as evidence of alcohol in breathalyzer or cannabis in saliva. Caffeine and nicotine are permitted but participants will be asked to refrain from consuming caffeine or nicotine products (including cigarettes) two hours prior to the study. Antihistamines are also not exclusionary but should not be used on the day of study.\n23. \\*Non-English speakers (must also be able to read and comprehend English\n\n    * We are excluding non-English speakers since the study includes questionnaires that are validated for English and only some are available in Spanish. The fMRI paradigms also require that the subject be able to speak, read and comprehend English.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for alcohol\u002Fdrugs on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing for all participants:\n\n* If a subject s breath alcohol (\\>0.08%) screen test is positive on days involving imaging (PET\u002FMRI) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive breath alcohol screens. If subject continues to show up intoxicated they will be withdrawn.\n* If urine drug screen is positive for THC-COOH a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If we are unable to perform the saliva drug screen for any reason, the study day procedures will be postponed. If the urine\u002Fsaliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study. Saliva THC is not required for determining eligibility.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine after 3 days of rescheduling they will be excluded.",{"count":200,"type":21},176,[24],"Background:\n\nGlucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD).\n\nObjective:\n\nTo learn how the brains of people with AUD respond to a GLP-1 drug.\n\nEligibility:\n\nPeople aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed.\n\nDesign:\n\nThis study consists of Part 1 and Part 2.\n\nPart 1 (Imaging Procedures): Five healthy volunteers will undergo 2 to 3 combined positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) scans, with an interval of 2 to 3 weeks between scans. For each scan, a radioactive substance (tracer) will be administered intravenously. Participants will undergo PET\u002FMRI scanning to assess brain activity during resting state. Methylphenidate (Ritalin) will be administered during each scan. Each imaging session will last approximately 2 hours. Tirzepatide and placebo will not be administered in Part 1. Participants with alcohol use disorder (AUD) are not included in Part 1. The purpose of this part of the study is to assess test\u002Fretest reproducibility of the PET\u002FMRI combined scan measures.\n\nPart 2 (Randomization to Tirzepatide \\& Placebo): Participants will be randomized to receive either Tirzepatide or Placebo first. Healthy Volunteers and AUD participants will receive both treatments in a crossover design. Tirzepatide and placebo will be administered via subcutaneous injection (under the skin) once weekly for 2 to 3 weeks. This treatment period will be followed by 2 to 3 PET\u002FMRI combined imaging scans described in the next paragraph. After a washout interval of approximately 2 to 3 weeks, participants will cross over to the alternate treatment (tirzepatide or placebo), administered once weekly for 2 to 3 weeks. This second treatment period will be followed by an additional 2 to 3 PET\u002FMRI scans. Participants may receive up to 3 doses of tirzepatide and 3 doses of placebo.\n\nPart 2 (Imaging Procedures): Healthy Volunteers and participants with an AUD will undergo PET\u002FMRI scans at two time points: following tirzepatide administration and following placebo administration. For each scan a radioactive substance (tracer) will be administered intravenously. Brain activity will be measured during PET\u002FMRI acquisition during resting state. Methylphenidate will be administered during 1 of the scans at each time point. Each imaging session will last approximately 2 hours. Participants will wear a device to track their activity for at least 1 week before each set of scans. They will have tests of their thinking, memory, and attention.",[204],"Alcohol Use Disorder (AUD)",[206,207,204,144,208],"Tirzepatide","Dopamine","GLP-1","2026-06-16",{"date":211,"type":38},"2026-06-17",{"date":213,"type":38},"2026-05-20",{"date":215,"type":21},"2031-12-31",{"name":44,"class":45},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":46},"100553283","phase-1-suvorexant-for-alcohol-use-disorder-aud-neural-mechanisms-100553283","NCT06484075","Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms","* INCLUSION CRITERIA:\n* All Participants\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, ages 18-75 years old.\n* Ability to understand and the willingness to sign a written informed consent document.\n\n  * AUD Participants\n\nTo be eligible to participate in this study, an individual with AUD must meet all of the \"All Participants\" inclusion criteria (listed above) and also meet the following criteria:\n\n* DSM 5 diagnosis of moderate or severe AUD.\n* Participants seeking treatment for their AUD.\n* Current AUD with minimum 5-year lifetime history of heavy drinking (SAMSHA's criteria for heavy drinking: for men 5 or more drinks\u002Fday on at least 5 different days per month; and for women 4 or more drinks\u002Fday on at least 5 different days per month).\n* Last alcohol use within the 7 days prior to enrollment in the Natural History protocol 14AA0181.\n* Self-reported insomnia\u002Fsleep problems: PSQI score \\> 4 and\u002For endorsing \"problems falling asleep or staying asleep throughout the night\".\n* Ability to take oral medication and be willing to adhere to the suvorexant\u002Fplacebo regimen.\n* Agreement to commit to at least 28 days, and up to 40 days, inpatient stay (starting from Natural History protocol enrollment).\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nEXCLUSION CRITERIA:\n\n-All Participants\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI.\n* Cannot lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner.\n* Body weight \\> 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.\n* Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n* Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n* Severe head trauma with loss of consciousness \\> 60 minutes.\n* Chronic recurrent primary psychotic disorders like schizophrenia and bipolar 1 disorder.\n* Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or 'suicidal thoughts' item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n* Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer's disease, Parkinson's disease, traumatic brain injury, clinically significant arrhythmias except bradycardia, and HIV+).\n* Hepatic enzymes (ALT\u002FGPT, AST\u002FGOT, Total Bilirubin, Direct Bilirubin) that are \\>5x the upper limit of normal, indicating severe hepatic impairment.\n\n  * Non-English speakers (must also be able to read and comprehend English).\n\n    * The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since it includes the administration of questionnaires, surveys and assessments that are validated for English; only some are available in Spanish. In addition, our fMRI paradigms require that the subject be able to speak, read and comprehend English.\n\n      * AUD Participants\n\nAn individual with AUD who meets any of the \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current daily use of stimulant medications, modafinil, wellbutrin, naltrexone, antipsychotics, or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan).\n* Current benzodiazepine, opioids, or stimulant misuse (must have misused 5+ days\u002Fweek for \\>1 year, and most recent use must have been within 7 days of inpatient admission).\n* Current severe substance use disorders (other than alcohol, cannabis, nicotine or caffeine). If a subject had a severe SUD (other than alcohol, cannabis, nicotine or caffeine), they must be in remission for at least 6 months prior to enrollment.\n* Major medical problems that are contraindicated for the use of suvorexant (narcolepsy, severe obstructive sleep apnea or severe chronic obstructive pulmonary disease, REM behavioral disorder) as determined by history and clinical exam.\n\nNote that AUD subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing:\n\n-If a subject's urine drug\u002Fbreath alcohol (\\>=0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed until BrAC \\\u003C0.08. This is not expected to happen in most cases especially since participants will have been detoxifying for 1-5 days (possibly longer) and should no longer test positive for BrAC at this point. After initial screening under 14AA0181, subjects will be in the inpatient unit detoxifying.\n\n* If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed. However, there are reports that THC can still be detected in saliva even eight days after cessation of drug use. Because of this, AUD subjects may proceed with study day testing procedures even if saliva results for THC are positive. If any AUD participants test positive for saliva THC-COOH, we may include those results as a covariate in our statistical analyses.\n* If any other urine results are positive, we may include those results as a covariate in our statistical analyses. It is important to note that the subjects will have been in the inpatient unit detoxifying from alcohol and won't have access to drugs of misuse during this time. Positive results could be indicative of slow metabolizers of drugs and subject may stay enrolled and participate in the imaging scans.\n\nWe minimized exclusion criteria pertaining to current medication use in the AUD group participants to make recruitment feasible and so the outcome can be better generalized to vulnerable AUD populations which have high rates of comorbid mental and physical illness requiring medication. Note however that although current daily use of naltrexone is an exclusion per above, once the imaging scans and study drug dosing are completed, standard of care treatment will be started a few days prior to discharge and this could include taking naltrexone daily. This will not be considered a violation or non-compliance or deviation from criteria listed above once the imaging studies are complete. Standard of care may start within 24 hours of last study drug medication dose or last brain imaging scan under the current protocol, whichever happens last. This treatment is initiated for a few days under the 14AA0181 Natural History protocol prior to discharge from the unit.\n\n-Control Participants\n\nA control individual who meets any of the criteria listed under \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current DSM-5 diagnosis of a psychiatric disorder that requires\u002Frequired daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n* History of moderate or severe substance use disorders (other than nicotine or caffeine).\n* The following current chronically used (past 2 months) medications are exclusionary: stimulant or stimulant-like drugs and medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antihistamines (sedating); beta-blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics (benzodiazepine or barbiturates); lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos); sedatives\u002Fhypnotics, systemic steroids. Note that nicotine and\u002For caffeine is not exclusionary.\n\nWhen developing this protocol to include healthy volunteers, we needed a population not taking medications that could impact our interpretation of dopamine level measurements, since we are hoping to get estimates of 'baseline' dopamine levels in this control population.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing in HV participants:\n\n* If a subject's urine drug\u002Fbreath alcohol (\\>0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive urine drug\u002Fbreath alcohol screens. If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If the urine\u002Fsaliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.\n* If a participants urine drug screen test is positive for marijuana (urine drug screen positive for THC-COOH) on the day of the scan, we will then perform a saliva drug screen to verify if THC is present. If positive, procedures will be postponed until it becomes negative.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine they will be excluded.","75 Years",{"count":225,"type":21},180,[24,115],"Background:\n\nAlcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.\n\nObjective:\n\nTo see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.\n\nEligibility:\n\nPeople aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD.\n\nSuvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.\n\nParticipants will wear a device that looks like a wristwatch to track their movements during their clinic stay.\n\nParticipants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.\n\nParticipants will have tests to assess their thinking, memory, and attention. They will have sleep studies.\n\nImaging scans and other tests will be repeated at the end of the study.\n\nHealthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.\n\n...",[118,204],[230,231,232,233,204,234],"Suvorexant","Sleep","Dopamine D2R","Dopamine D1R","Alcohol Craving",{"date":211,"type":38},{"date":237,"type":38},"2024-11-21",{"date":239,"type":21},"2029-12-31",{"name":44,"class":45},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":46},"100596542","phase-2-tirzepatide-in-metald-100596542","NCT07046819","Tirzepatide in MetALD","A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 21 or older\n2. Ability to provide written informed consent\n3. Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)\n4. Males: Agree to abstain or use accepted form of contraception, such as condoms.\n5. Diagnosis of AUD as confirmed by MINI\n6. Current alcohol use as assessed via the TLFB (\\>14 standard drinks per week for males and \\>7 standard drinks per week for females on average for the last 8 weeks)\n7. Liver steatosis as determined by Fibroscan (CAP score \\>240) at screening\n8. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n9. metALD as defined by at least one out of 5 criteria at screening:\n\n   1. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n   2. Fasting serum glucose \\>= 5.6mmol\u002FL \\[100mg\u002FdL\\] or HbA1c \\>=5.7%\n   3. Blood pressure \\>=130\u002F85 or specific antihypertensive drug treatment\n   4. Plasma triglycerides \\>=1.70mmol\u002FL \\[150mg\u002FdL\\] or lipid lowering treatment\n   5. Plasma HDL-cholesterol less than 1.0mmol\u002FL \\[40mg\u002FdL\\] or lipid lowering treatment\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Treatment seeking for alcohol use disorder\n2. History of a serious hypersensitivity reaction to GLP-1RA\u002FGIPRA\n3. Current\u002Fpast use of GLP-1RA\u002FGIPRA within the last 3 months\n4. Clinically significant and\u002For unstable cardiovascular disease over the past 12 months\n5. History of diabetes mellitus or blood hemoglobin A1c (HbA1c) \\>= 6.5 % at screening\n6. Any underlying clinically significant and\u002For unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices\n7. Subjects with platelets count of less than 110,000\u002F mm\\^3\n8. Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening\n9. Bilirubin 2x UNL or Creatinine \\> 2 mg\u002FdL at screening\n10. Patients with coagulopathy defined as INR \\>1.5, prothrombin time prolonged by \\> 3s, and\u002For platelets \\\u003C75,000 \u002F mm\\^3 at screening\n11. Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and\u002For positive Hepatitis C antibody (HCV) at screening\n12. Chronic renal failure as estimated by glomerular filtration rate (GFR) \\\u003C 60mL\u002Fmin\u002F1.73 m\\^2 at screening\n13. History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n14. History of previous bariatric surgery or transplant surgery\n15. Patients with significant hematologic abnormalities, as defined by hemoglobin \\\u003C 8g\u002FdL and\u002For white blood count \\\u003C1500 cells\u002FmicroL\n16. Current or prior history of any clinically significant disease, including, seizure disorder, epilepsy, alcohol related seizures within 12 months of screening, uncontrolled endocrine disease, hemorrhagic stroke, cancer within the past 5 years or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study\n17. Use of any medications that interfere with tirzepatide\n18. Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA\u002FGIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors\n19. Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids\n20. Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures\n21. Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year\n22. History of serious mental illnesses including psychotic disorders, bipolar disorders, severe anxiety, mood, or trauma-related disorders and other psychiatric conditions which in the opinion of the investigators would impede the patient's participation or compliance in the study\n23. History of liver decompensation events such as hepatic encephalopathy or ascites\n24. History of severe gastroparesis\n25. History of pancreatitis in the last 5 years or if subject has chronic pancreatitis\n\nFor optional MRI: a) Presence of ferromagnetic objects in the body that may be adversely affected by or contraindicated for MRI, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report b) Use of MRI- incompatible intrauterine device (IUD).\n\nIndividuals who are pregnant or breastfeeding, or with severe hepatic or renal liver impairment will be excluded from this study because there is no clinical data on the safety of tirzepatide in these populations, including the impact on the fetus or infant. To assess pregnancy status, participants who can become pregnant will be required to take a urine pregnancy test and to test negative before administering study drug.",{"count":249,"type":21},120,[115],"Background:\n\nPeople with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake.\n\nObjective:\n\nTo test Tirzepatide in people with AUD and MetALD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD and MetALD.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver.\n\nThese tests will be repeated in a baseline visit. This visit will take up to 6 hours.\n\nTirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours.\n\nAll tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.",[253,63],"Metabolic Alcohol-associated Liver Disease",[255,256,164,257],"BMI","Weight","Metabolism","2026-06-13",{"date":209,"type":38},{"date":261,"type":38},"2026-06-11",{"date":263,"type":21},"2026-07-30",{"name":44,"class":45},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":271,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":46},"100491299","individual-variations-of-taste-and-smell-perception-in-alcohol-use-disorder-aud-100491299","NCT05677321","Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n* Individuals between 18 to 65 years of age. Although the age range of participants recruited in the NIAAA Natural History protocol is between 18-77 years, due to documented knowledge that taste and smell diminishes with age, we will limit age to this range.\n* Individuals with a diagnosis of AUD (for the AUD cohort) OR without a diagnosis of AUD (for the non-AUD cohort) per clinician assessment\n* Able to provide their own consent.\n* Due to the extensive questionnaires (administered in English language only) that participants must complete independently, fluency in the English language is needed. Hence, participants must be able to read and understand English.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Diagnosis by a medical professional of morbid obesity or BMI \\> 40 or renal disease.\n* Any history of chronic rhinitis, eating disorder, chronic upper respiratory infection, chronic allergic rhinitis, or nasal polyps in the last 6 months of screening, or current daily use of nasal sprays.\n* Altered cranial nerves associated with taste and olfaction identified by neurological evaluation during physical exam (screening visit).\n* Positive pregnancy test, currently pregnant or breastfeeding.\n* Hypoglycemic drug intake.\n* Currently using medications known to inhibit taste response (GLP1 agonists).\n* Currently experiencing temporary change\u002Floss of taste and\u002For smell (individual may be rescreened when symptoms resolve).\n* Persistent loss of taste and\u002For smell due to COVID-19 or other reason.\n* NIAAA employees\u002Fstaff or subordinates\u002Frelatives\u002Fco-workers of NIAAA employees\u002Fstaff or study investigators.\n\nfMRI Exclusion Criteria\n\n* Claustrophobia\n* Ferromagnetic metal in the cranial cavity or eye, e.g., aneurysm clip implanted neural stimulator, cochlear implant, ocular foreign body.\n* Presence of implanted cardiac pacemaker or auto-defibrillator.\n* Individuals with an insulin pump.\n* Presence of an irremovable body piercing.\n* Individuals who are pregnant or breastfeeding during screening, or who become pregnant during the study, will be excluded from participation due to risk of exposing the fetus to undue magnetic field hazards associated with MRI.",{"count":272,"type":21},475,"Background:\n\nAlcohol use disorder (AUD) is the most common substance use disorder in the world. Long-term AUD can affect a person s sense of taste and smell. This natural history study will compare alcohol drinking behaviors and measures of taste and smell in people with and without AUD.\n\nObjective:\n\nTo understand how alcohol use changes the senses of taste and smell.\n\nEligibility:\n\nPeople aged 18 to 65 years with or without AUD.\n\nDesign:\n\nParticipants will be screened. They will have several tests to assess their smell and taste functions. They will answer questions about their eating, alcohol use, and smoking or vaping habits.\n\nParticipants will have 2 study visits.\n\nThey will give samples of blood, nasal mucous, saliva, stool, and urine.\n\nTheir bodies will be measured. They will undergo a type of scan that uses X-rays to measure their body composition.\n\nThey will complete taste measurements. They will taste liquids by swishing them in their mouth, without swallowing. Then, they will be asked what they can detect and which flavors they preferred.\n\nThey will also complete smell measurements. They will be asked if they can identify strong odors on a metal wand. They will be asked to rate the intensity and pleasantness of odors.\n\nTheir brain activity in the frontal regions will be measured while they smell various odors. For this, we will use a brain imaging tool called functional near infrared spectroscopy.\n\nThey will have sensory testing. Sensations such as pressure, pinpricks, heat, or vibrations will be applied to their skin. Then, they will be asked what they felt.\n\nThey will keep diaries. They will write down what they eat (for 3 days), the alcohol they drink (3 days), and how much they sleep (14 days). They will wear a wristwatch-like device that records their activity for 14 days.",[63],[276,277,97],"chemosensation","Preference",{"date":209,"type":38},{"date":280,"type":38},"2024-01-09",{"date":282,"type":21},"2027-12-31",{"name":44,"class":45},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":46},"100579045","phase-1-role-of-metal-ion-transporter-zip8-in-alcohol-related-behaviors-100579045","NCT06819189","Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors","Role of Metal Ion Transporter ZIP8 in Alcohol Related Behaviors","* INCLUSION CRITERIA:\n\n  1. Male and female participants between 21-60 years of age. \\[Based on: identification provided to Clinical Center Admissions office\\].\n  2. Non-smokers with no history of smoking in the past year and not a daily smoker for more than 1 month in their lifetime. \\[Based on: smoking history questionnaire, Additional History Form\\]\n  3. Participants of European ancestry: the minor T allele of rs13107325, has a frequency of 0.08 in European ancestry, but is almost absent in Asian and African populations (http:\u002F\u002Fwww.ensembl.org). Due to the rare occurrence of the T allele and to avoid populations stratification in this small sample-sized study, only participants with self-reported White racial category (European ancestry) will be enrolled in this study.\n  4. Inclusion criteria for persons of childbearing potential: Use of adequate method of birth control during the study, if participant is sexually active and is not surgically sterilized. Adequate methods of contraception include abstinence, 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 same-sex sexual partner(s). Justification: To minimize the risk of administering alcohol to pregnant persons of childbearing potential, given the known effects of alcohol exposure on fetuses. \\[Based on: medical history\\].\n  5. Ability to understand the written consent form and willing to sign it. \\[Based on: consent quiz\\].\n\nEXCLUSION CRITERIA:\n\n1. Current history (past 12 months) of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, or positive hepatitis (A, B antigen, or C), or HIV test. Justification: Many illnesses may alter the neuropsychological effects of alcohol as well as MRI measures. Hepatitis can alter liver function and alcohol pharmacokinetics. HIV infection can alter brain function. \\[Based on: clinically significant findings on medical history and physical exam, ECG, laboratory tests\\].\n2. Current history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders. Justification: Concurrent psychopathology can alter brain function and alcohol response. \\[Based on: SCID interview\\]\n3. Lifetime history of psychotic disorders, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or eating disorder. Justification: These disorders can have long-term effects on brain function and alcohol response. \\[Based on: SCID interview\\]\n4. Current or lifetime diagnosis of alcohol or substance use disorder. Past mild AUD or past mild SUD with no current symptoms for at least 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 an exploratory analysis. We will also do a follow-up telephone\u002Ftelehealth visit with these participants to assess any changes in alcohol or substance use or problems related to their participation in the study. \\[Based on: SCID interview\\].\n5. 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. \\[Based on: medical history\\]\n6. 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. \\[Based on: medical history\\].\n7. 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. \\[Based on: alcohol flushing questionnaire\\].\n8. 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. \\[Based on: laboratory tests and breathalyzer test\\].\n9. 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 criterion. Additionally, withdrawal symptoms would be a major safety concern for participants, and a major confound in the assessment of alcohol response and brain function. \\[Based on: CIWA assessment\\].\n10. Medication exclusion criteria: \\[Based on Medical history and physical exam, Additional History Form\\].\n\n    * Use of prescription or OTC medication 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 antihistamines, pain medicines, and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib, and naproxen, and unable to refrain from these medications for 48 hours prior to study visits.NOTE: Seasonal use of antihistamines is not-exclusionary unless participants are unable to refrain from these medications for\n\n      48 hours prior to study visits.\n    * Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to screening or screening update visit. 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.\n11. 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 comfortably on back for up to 2 hours in the MRI scanner. Justification: To minimize risk and discomfort.\n\n    \\[Based on: MRI Safety Screening Questionnaire, Additional History Form\\]\n12. Exclusion criteria for persons of childbearing potential:\n\nJustification: To minimize the risk of administering alcohol to pregnant or nursing persons, given the known effects of alcohol exposure on fetuses and infants.\n\n* Pregnant \\[Based on: urine beta-hCG test at screening\\]. Persons of childbearing potential must also test negative on urine beta-hCG test at the start of every study visit.\n* Breast-feeding \\[Based on: Medical history and physical exam\\].",{"count":292,"type":21},50,[24],"Background:\n\nAlcohol use disorder (AUD) can damage people s health, work, and family. Researchers want to know more about why some people are more vulnerable to AUD than others. The ZIP8 gene may be linked to an increased risk of AUD. Researchers want to find out how different forms of the ZIP8 gene affect how healthy people drink alcohol and how alcohol affects their brain.\n\nObjective:\n\nTo study how genes may affect how people drink alcohol and how it affects their brain.\n\nEligibility:\n\nHealthy people aged 21 to 60 years. They must not smoke, and they must have no history of AUD. They must have European ancestry and be enrolled in Natural History Protocol (14-AA-0181).\n\nDesign:\n\nParticipants will have 2 study visits.\n\nAt the first visit, participants will be given alcohol; it will be infused through a tube attached to a needle inserted into a vein. They may self-administer each dose by pressing a button. Over time, they will have to press the button an increasing number of times to receive more alcohol. The infusion period will last 2.5 hours.\n\nParticipants will have blood samples taken and breath measurments, and they will do computer tasks and complete questionnaires during and after the infusion. After the infusion, they will remain in the clinic until their breath alcohol levels drop to a safe level.\n\nAt the second visit, participants will have an imaging scan of their brain. They will do tasks and play games on a computer screen during the scan.\n\nSome participants may have an extra visit for screening. A mid-study visit may also be needed if more than 6 months pass between the 2 study visits....",[296],"Healthy Volunteer",[164],"2026-05-29",{"date":300,"type":38},"2026-06-01",{"date":302,"type":38},"2025-06-10",{"date":282,"type":21},{"name":44,"class":45},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100617949","phase-2-human-laboratory-study-of-apremilast-for-alcohol-use-disorder-100617949","NCT07325266","Human Laboratory Study of Apremilast for Alcohol Use Disorder","Inclusion Criteria (not exhaustive list):\n\n1. Be at least 21 years of age.\n2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).\n3. Have a BAC by breathalyzer equal to 0.000 when s\u002Fhe signed the informed consent document (either just prior to or immediately after signing consent).\n4. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.\n5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.\n6. Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:\n\n   * oral contraceptives,\n   * contraceptive sponge,\n   * patch,\n   * double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal),\n   * intrauterine contraceptive system,\n   * etonogestrel implant,\n   * medroxyprogesterone acetate contraceptive injection,\n   * complete abstinence from sexual intercourse, and\u002For\n   * hormonal vaginal contraceptive ring.\n7. Be willing to adhere to the investigational product dosing schedule.\n8. Complete all assessments required at screening and baseline.\n9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s\u002Fhe will lose his\u002Fher housing by Study Week 6.\n10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6.\n11. Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.\n12. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment.\n13. Be someone who in the opinion of the investigator would be expected to complete the study protocol.\n14. Agree to the schedule of visits, verbally acknowledge that s\u002Fhe will be able to attend each scheduled visit, participate in phone visits and that s\u002Fhe does not have any already scheduled events or a job that may substantially interfere with study participation.\n15. If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:\n\n    * SSRIs\n    * Dual uptake inhibitors\n    * SNRIs\n    * Tricyclic antidepressants\n    * MAOIs\n    * Bupropion\n16. Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.\n17. Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\nContact study site for exclusion criteria",{"count":312,"type":21},100,[115],"Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.\n\nSecondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.",[63,316],"Alcohol Misuse","2026-04-30",{"date":319,"type":38},"2026-05-01",{"date":321,"type":38},"2026-04-03",{"date":323,"type":21},"2027-07-31",{"name":44,"class":45},3,{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":339,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":46},"100422476","phase-1-safety-tolerability-and-bioeffects-of-alirocumab-in-non-treatment-seeking-heavy-drinkers-100422476","NCT04781322","Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Study of Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers","* INCLUSION CRITERIA:\n\n  1. Male or female between the age of 21 and 65 years.\n  2. Ability to provide written informed consent.\n  3. Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives; use of barrier method of contraceptive, such as condoms; 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).\n\n     Males: Agree to abstain or use accepted form of contraception, such as condoms.\n  4. Current chronic alcohol use, non-treatment seeking heavy drinker (an average of \\>= 20 standard drinks per week for at least 12 weeks).\n\nEXCLUSION CRITERIA:\n\n1. Treatment seeking for alcohol use disorder.\n2. History of a serious hypersensitivity reaction to PCSK9 inhibitors, monoclonal antibodies, or any component of the drug product.\n3. Chronic use of statins within eight weeks of the study to treat hypercholesteremia, or fibrates, with the exception of fenofibrates, within six weeks of the study.\n4. Current\u002Fpast use of PCSK9 inhibitors.\n5. Clinically significant and\u002For unstable cardiovascular-disease over the past 12 months.\n6. Current or prior history of any clinically significant disease, including, fibromyalgia, severe neuropathic pain, seizure disorder, uncontrolled endocrine disease known to influence serum lipids or lipoproteins, hemorrhagic stroke, cancer within the past 5 years (except for adequately treated basal skin cancer, squamous cell skin cancer, or in situ cervical cancer), uncontrolled (defined as Hgb A1c \\>8%) or newly diagnosed (within 3 months prior to screening) diabetes, or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study.\n7. Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and\u002For positive Hepatitis C antibody (HCV) at screening.\n8. Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening will be excluded. Bilirubin 2x UNL or Creatinine \\> 1.5 mg\u002Fdl at screening will be excluded.\n9. Triglycerides \\> 400mg\u002FdL (\\>4.52 mmol\u002FL) at screening.\n10. Chronic renal failure as estimated by glomerular filtration rate (GFR) \\\u003C 60mL\u002Fmin\u002F1.73 m\\^2 at screening.\n11. Any underlying clinically significant and\u002For unstable acute or chronic liver disease unrelated to alcohol use at screening.\n12. Patients with coagulopathy defined as INR \\>1.5, prothrombin time prolonged by \\> 3s, and\u002For platelets \\\u003C75,000 \u002F mm\\^3 at screening.\n13. Use of any medications that interfere with blood clotting.\n14. Patients with significant hematologic abnormalities.\n15. Significant obesity (Obesity Class III) defined as BMI greater than or equal to 40 at screening.\n16. History of previous bariatric surgery or transplant surgery.\n17. History of plasmapheresis treatment within 2 months prior to screening or plans to undergo plasmapheresis during the study.\n18. Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids, unless used as replacement therapy for pituitary\u002Fadrenal disease with a stable regimen for at least 6 weeks prior to screening. Estrogen or testosterone therapy, unless regimen stable for 6 weeks prior to screening visit.\n19. Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures.\n20. Plan to use red yeast rice during the study.\n21. Presence of any current suicidality.\n22. History of epilepsy or alcohol-related seizures in the last 12 months.\n23. Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study, such as psychosis, delirium or acute change of mental status.\n\nFor optional MRI: a) Presence of ferromagnetic objects in the body that may be adversely affected by or contraindicated for MRI, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report b) Use of MRI-incompatible intrauterine device (IUD).",{"count":312,"type":21},[24],"Background:\n\nDrinking alcohol can lead to swelling and injury in the liver. Long-term heavy drinking may lead to liver disease. Researchers want to study the relationship between a drug called alirocumab, alcohol use, and liver functioning\u002Fswelling.\n\nObjective:\n\nTo study the effects of alirocumab in people who drink alcohol.\n\nEligibility:\n\nHealthy adults ages 21 to 65 who regularly consume an average of 20 or more drinks per week.\n\nDesign:\n\nParticipants will be screened under protocol 14-AA-0181.\n\nParticipants will get alirocumab or a placebo as an injection under the skin.\n\nParticipants will give blood and urine samples. They will have physical exams.\n\nParticipants will have FibroScans . It measures liver and spleen stiffness. Participants will lie on a table. They will expose the lower right and left side of their chest. The machine will send a small vibration to the liver.\n\nParticipants may have magnetic resonance imaging (MRI) scans of the liver. The MRI scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A device called a coil will be placed over their liver.\n\nParticipants will have a Doppler scan and ultrasound. These tests measure blood flow in the body.\n\nParticipants will have an electrocardiogram. It measures heart function.\n\nParticipants will fill out surveys about how they are feeling, their alcohol consumption, and other behaviors. They will complete cognitive tasks on a computer.\n\nParticipants will meet with a clinician. They will discuss the participant s assessment results, patterns of drinking, and possibly stopping or cutting down on drinking.\n\nParticipation will last for 8 weeks. Participants will have 9 study visits.",[337,338],"Alcohol Associated Liver Disease","Heavy Drinking Behavior",[164,340,341,342,343],"Liver","PCSK9","Fatty Liver","Inflammation","2026-04-25",{"date":346,"type":38},"2026-04-28",{"date":348,"type":38},"2021-10-19",{"date":42,"type":21},{"name":44,"class":45},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":46},"100536807","phase-4-temporally-resolved-electrophysiology-of-acamprosate-treatment-of-alcohol-use-disorder-100536807","NCT06269627","Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol 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\n1. Age 21-65. In younger participants, the central nervous system has not sufficiently developed, whereas in older participants, degenerative changes may confound the studied measures. Moreover, the minimum legal drinking age is 21 years.\n2. Enrolled in NIAAA natural history protocol 14-AA-0181.\n3. Admitted to alcohol treatment program of NIAAA\\* with moderate to severe alcohol use disorder by a clinician at the time of admission.\n4. Determination by the attending physician or licensed practitioner caring for the patient that the patient s current clinical status is stable enough to provide informed consent for research.\n\n   * The determination of the severity of AUD is via Structured Clinical Interview for DSM-5 after particpant s enrollment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics currently or within the last 4 weeks.\n\n   Individuals treated with acamprosate in the last 4 weeks would also be excluded.\n2. Pregnancy at admission (negative urine pregnancy test required).\n3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and\u002For cranial surgery.\n4. History of epilepsy.\n5. History of non-substance related psychotic disorders.\n6. Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds; and\u002For severe renal impairment, manifested as creatinine clearance \\\u003C= 30 mL\u002Fmin).\n7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.",{"count":358,"type":21},48,[360],"PHASE4","Background:\n\nChronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.\n\nObjective:\n\nTo learn more about how acamprosate affects brain function in people with AUD.\n\nEligibility:\n\nPeople aged 21 to 65 years with moderate to severe AUD.\n\nDesign:\n\nParticipants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.\n\nAcamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.\n\nParticipants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.\n\nParticipants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.\n\nParticipants may have up to three follow-up visits for 6 months.",[63],[364,365,366,367,368,369,370,371],"Multimodal","Neuroscience","Resting State","Event-Related Potentials","Artificial Intelligence","Machine Learning","ELECTROENCEPHALOGRAPHY","Acamprosate","2026-02-28",{"date":374,"type":38},"2026-03-03",{"date":376,"type":38},"2025-05-07",{"date":42,"type":21},{"name":44,"class":45},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":15,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":385,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":46},"100417377","mechanisms-underlying-individual-variations-of-taste-and-smell-in-obesity-100417377","NCT04714892","Mechanisms Underlying Individual Variations of Taste and Smell in Obesity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Males and females between 18 to 65 years of age. Due to documented knowledge that taste and smell changes with age, we will limit the cohort within this age range.\n* BMI between 18.5 and 29.9 kg\u002Fm\\^2 for healthy controls or between 30 and 39.9 kg\u002Fm\\^2 for obese subjects\n* Fasted plasma glucose levels between 68-126 mg\u002Fdl or per Clinical Center ranges, and hemoglobin A1C\\\u003C6.5%\n* Able to provide his\u002Fher own consent\n* Able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Because type-2 diabetic subjects have blunted taste responses, subjects with diagnosis of type II diabetes will be excluded.\n* Hypoglycemic drug intake.\n* Weight change of more than 15 pounds in the 6 months prior to screening\n* Positive pregnancy test, currently pregnant or breastfeeding.\n* Currently using any of the following medications: steroidal or nonsteroidal antiinflammatory medications, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, or antibiotics.\n* Received a diagnosis by a medical professional of morbid obesity, liver or renal disease.\n* Individuals with current heavy drinking. Women who drink 4 drinks or more in one occasion and 7 drinks in a week. Men who drink 5 drinks or more in one occasion and more than 14 drinks a week.\n* Use of tobacco products or illicit drugs (as determined by urine drug screen and\u002For history\u002Fphysical exam) in the last 30 days.\n* Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric).\n* Any self-reported history of chronic rhinitis, eating disorder (including binge eating), chronic upper respiratory infection, chronic allergic rhinitis, or nasal polyps in the last 6 months of screening, or current daily use of nasal sprays.\n* Abnormal complete blood count (CBC): White Blood Cell Count \\\u003C 4 or \\> 10 K\u002FuL, Red Blood Cell Count \\\u003C 4 or \\> 7 M\u002FuL, Hemoglobin \\\u003C 12 g\u002FdL for females or \\\u003C 13 g\u002FdL for males or any clinical signs\u002Fsymptoms that indicate iron deficiency anemia per clinician s judgment at screening \\[National Heart, Lung and Blood Institute (NHLBI) definition (Anemia - Iron-Deficiency Anemia, Diagnosis NHLBI, NIH)\\].\n* Bariatric surgery within the last 12 months of screening.\n* History of cancer (e.g., head and neck cancer) and\u002For history of cancer treatment (e.g., radiotherapy to the head and neck area or chemotherapy).\n* Altered cranial nerves identified by neurological evaluation during physical exam (screening visit).\n* Currently experiencing temporary change\u002Floss of taste and\u002For smell.\n* Persistent loss of taste and\u002For smell due to COVID-19 or other reasons.\n* Unable to read and understand English. Since all self-report measures are in English only, participants need to be able to read and understand the English language.\n* NIAAA employees\u002Fstaff or subordinates\u002Frelatives\u002Fco-workers of NIAAA employees\u002Fstaff or study investigators.",{"count":386,"type":21},350,"Background:\n\nChanges to the sense of taste or smell can change eating behavior. This may contribute to obesity. Researchers want to see how taste and smell perceptions that affect food choices may differ between people with obesity and without obesity.\n\nObjective:\n\nTo understand the role that senses of taste and smell play in food intake.\n\nEligibility:\n\nAdults ages 18-65 with obesity and without obesity\n\nDesign:\n\nParticipants will be screened with a medical history and physical exam. They will have a neurological and sensory exam. They will give blood and urine samples. They will be checked for previous SARS-CoV-2 infection. They will complete questionnaires about their eating habits, alcohol use, and smoking history.\n\nParticipants will have 2 study visits.\n\nParticipants will give stool, urine, blood, hair, nasal, and saliva samples. These samples will be used for gene testing.\n\nParticipants will have their weight, height, and hip and waist circumference measured. They will have an imaging scan that measures body composition.\n\nParticipants will complete questionnaires about their health, eating habits, and food preferences.\n\nParticipants will have taste tests and smell tests. They will have sensory tests to assess their response to stimuli.\n\nParticipants will have a dietary assessment. They will complete a food diary and a diet history questionnaire.\n\nParticipants will get a meal to eat. Data will be collected about their experience.\n\nParticipants will complete a sleep diary and wear a watch to measure their activity....",[389],"Obesity",[276,391,392,393,394,97],"Olfaction","Diet","obese","Perception","2025-08-09",{"date":397,"type":38},"2025-08-12",{"date":399,"type":38},"2022-05-11",{"date":42,"type":21},{"name":44,"class":45},""]