[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-use-disorder-aud\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-use-disorder-aud":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,43,74,93,123,149,177,201,225,250,281,314,337,358,382,404,428,457,478,507,538,559,583,612,638],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100526550","phase-1-influence-of-mavoglurant-on-alcohol-craving-and-drinking-in-heavy-drinkers-100526550",false,"NCT06136195","Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers","Inclusion Criteria:\n\n1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).\n2. Ability to read English at 6th grade level or higher.\n3. Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).\n4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).\n\nExclusion Criteria:\n\n1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.\n2. Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.\n3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.\n4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm\u002Frisk behaviors (e.g. suicidal\u002Fhomicidal risk) a licensed clinician will be consulted immediately.\n5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.\n6. Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.\n7. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \\> 3 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine \\>2.0 times ULN.\n8. Neurological trauma or disease, delirium or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and Principal Investigator, may put the patient at risk because of participation in the study.\n9. Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.\n10. Women who are pregnant or nursing.\n11. Participants who refuse to use a reliable method of birth control.\n12. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n13. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n14. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.\n15. Subjects who have donated blood within the past 6 weeks.","ALL","21 Years","50 Years",{"count":20,"type":21},63,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.",[27,28,29],"Alcohol Consumption","Heavy Drinker","Alcohol Use Disorder (AUD)","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2024-07-01",{"date":38,"type":21},"2028-05-31",{"name":40,"class":41},"Yale University","OTHER",2,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100604386","phase-2-cannabidiol-as-an-adjunct-treatment-for-alcohol-withdrawal-and-craving-100604386","NCT07148843","Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving","Inclusion Criteria\n\n* Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder\n* Age 21-65\n* Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning (i.e., unable to attend work or engage in typical activities) AND\u002FOR required medications to manage symptoms.\n* Drinking at least 8 drinks a day over the two weeks prior to screening.\n* Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen\n* Shipley vocabulary score \\> 18, corresponding to 5th grade reading level.\n* Demonstrated understanding of informed consent and ability to consent to participation in the study.\n\nExclusion Criteria\n\n* Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe gastritis, hemoptysis, hematochezia, or melena.\n* Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission\n* Regular use (e.g., more than twice a week) of cannabis or CBD products.\n* Regular use of benzodiazepines (e.g., twice a week or more) within the last three months\n* Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including Cannabis Use Disorder (except for alcohol and tobacco)\n* Urine drug screen indicating the presence of substances other than cannabis at screening.\n* Unstable and\u002For compromising medical or psychiatric conditions that would interfere with participant safety as determined by study physician.\n* Current pregnancy\n* BMI \\\u003C17\n* History of anorexia nervosa or bulimia in the past 2 years\n* History of seizures or seizure disorder outside of alcohol-withdrawal related seizures\n* Systolic blood pressure (SBP) \\> 180, Diastolic Blood Pressure (DBP) \\> 120 or pulse \\> 120 during screening or upon admission\n* Any of the following laboratory values during screening or upon admission:\n\n  * AST \\> 165 U\u002FL (normal range 19-55)\n  * ALT \\> 216 U\u002FL (normal range 19-72)\n  * Alkaline phosphatase \\> 378 U\u002FL (normal range 38-126)\n  * Total bilirubin \\>2.5 mg\u002Fdl (normal values=0.3-1.0 mg\u002FdL)\n  * Non-fasting glucose \\> 250 mg\u002Fml (normal range 65-179)\n  * Hematocrit \\\u003C 38 % (normal range 41-53)\n  * Hemoglobin \\\u003C 12 g\u002Fdl (normal range 13.5-17.5) or any other laboratory value significantly outside the normal range\n* Use of a prescription medication (except for birth control prescriptions) within 14 days of study entry, which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication in which CYP2C9, CYP2C19, CYP1A2, CYP2B10, or CYP3A4 enzymes are major metabolizers.\n* ECG with corrected QT interval (QTC) \\>\u002F= 500 ms and\u002For presence of clinically significant abnormality\n* Participation in other clinical trials within the past 60 days\n* Court-mandated participation in alcohol treatment or pending incarceration","65 Years",{"count":51,"type":21},105,[53,54],"PHASE2","PHASE3","Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.",[29,57,58],"Withdrawal From Addictive Substance; Detoxification","Craving",[60,61,62],"alcohol abstinence","alcohol withdrawal treatment","detoxification","NOT_YET_RECRUITING","2026-08-17",{"date":66,"type":34},"2026-08-18",{"date":68,"type":21},"2026-10-01",{"date":70,"type":21},"2030-10-31",{"name":72,"class":41},"Johns Hopkins University",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":73},"100521519","phase-1-the-potential-therapeutic-effects-of-psychedelic-n-n-dimethyltryptamine-dmt-on-alcohol-use-disorder-aud-100521519","NCT06070649","The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder\n* Medically healthy\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Unstable medical conditions",{"count":20,"type":21},[24],"This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.",[29,84,85],"Alcohol-Related Disorders","Alcohol Use","2026-08-16",{"date":66,"type":34},{"date":89,"type":34},"2025-08-04",{"date":91,"type":21},"2027-08-01",{"name":40,"class":41},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":73},"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.",true,"18 Years","75 Years",{"count":103,"type":21},180,[24,53],"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...",[107,29],"Healthy Volunteers",[109,110,111,112,29,113],"Suvorexant","Sleep","Dopamine D2R","Dopamine D1R","Alcohol Craving","2026-08-15",{"date":66,"type":34},{"date":117,"type":34},"2024-11-21",{"date":119,"type":21},"2029-12-31",{"name":121,"class":122},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":148,"locationsCount":73},"100652472","phase-1-semaglutide-dose-effects-on-metabolic-and-stress-hormone-craving-and-alcohol-use-outcomes-100652472","NCT07772960","Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes","SEMA AUD","Inclusion Criteria:\n\n* Male and females ages 18-60 and BMI in 30-49.9 kg\u002Fm2;\n* regular weekly alcohol use (at least 3X\u002Fweek) prior to admission;\n* must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;\n* Good health as verified by screening and physical examination;\n* Able to read English and complete study evaluation;\n* Able to provide informed written and verbal consent.\n\nExclusion Criteria:\n\n* Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;\n* Current use of opiates;\n* Current use of psychiatric medications, including benzodiazepine-based sedatives\u002Fanxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;\n* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);\n* Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \\>6.5% and on current medications for T2D treatment;\n* Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;\n* Current use of any anti-obesity medications;\n* Prior history of bariatric surgery or current intragastric balloon;\n* Current participation in structured meal replacement or weight loss program;\n* Weight loss of \\>=10% over the preceding 6 months;\n* Women who are pregnant, nursing or refuse use of reliable form of birth control.","68 Years",{"count":132,"type":21},90,[24],"This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.",[29,136],"Obesity (BMI Equal to or >30)",[138,139,140,141,142],"Alcohol Use Disorder","alcohol craving","Semaglutide","food craving","alcohol intake","2026-08-14",{"date":31,"type":34},{"date":68,"type":21},{"date":147,"type":21},"2031-10-31",{"name":40,"class":41},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":73},"100631676","phase-2-oea-for-young-adults-with-alcohol-use-disorder-100631676","NCT07503782","OEA for Young Adults With Alcohol Use Disorder","Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder","Inclusion Criteria:\n\n* Age 18 to 25.\n\nCall study team for additional screening and information.","25 Years",{"count":158,"type":21},42,[53],"The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive function, and alcohol use in young adults ages 18 to 25 with alcohol use disorder (AUD). The main questions it aims to answer are:\n\n* Does OEA reduce peripheral markers of immune activation (IL-6, TNF-α, IL-1β, and LPS)?\n* Does OEA alter oral microbiome composition?\n* Does OEA improve neurocognitive measures of reward sensitivity and impulsivity?\n\nResearchers will compare OEA to a placebo (a look-alike substance with no active ingredient) to determine whether OEA improves biological and behavioral outcomes associated with AUD.\n\nParticipants (N = 42) will:\n\n* Be randomly assigned to receive 300mg TRIPTI (providing 250 mg\u002Fday of OEA) or placebo for 6 weeks.\n* Provide blood, saliva, and urine samples\n* Complete cognitive testing and questionnaires\n* Report alcohol use during the study\n* Attend in-person study visits for monitoring and assessments\n\nThis randomized, double-blind, placebo-controlled pilot trial will provide preliminary data on the potential efficacy of OEA as a multi-system intervention for young adults with AUD.",[29],[163,164,165,166,167],"OEA","oleoylethanolamide","AUD","Oral microbiome","Alcohol","2026-08-10",{"date":170,"type":34},"2026-08-12",{"date":172,"type":21},"2026-11-01",{"date":174,"type":21},"2031-06-01",{"name":176,"class":41},"Medical University of South Carolina",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":49,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100650319","alpha-down-eeg-neurofeedback-for-alcohol-use-disorder-feasibility-trial-100650319","NCT07746154","Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial","Neurofeedback","Inclusion Criteria:\n\nAdults ages 18-65 Meets DSM-5 criteria for current Alcohol Use Disorder Willing and able to provide informed consent Participants must report alcohol consumption within the past 30 days. Not requiring inpatient withdrawal management at the time of enrollment\n\nExclusion Criteria:\n\nHistory of epilepsy or seizure disorder (excluding uncomplicated alcohol withdrawal seizures) Current psychosis, mania, or acute suicidality, or any psychiatric condition that would impair the ability to provide informed consent or safely participate Acute alcohol intoxication at the time of study visits (as determined by breathalyzer) Pregnancy or breastfeeding Implanted electronic medical devices or metal in the head (excluding dental work), if incompatible with EEG procedures Severe cognitive impairment interfering with informed consent or participation Any medical or psychiatric condition that, in the opinion of the investigators, would make participation unsafe or interfere with study procedures",{"count":185,"type":21},10,[187],"NA","This pilot study is testing a short brain training program called neurofeedback in adults with alcohol use disorder. Participants will complete three sessions over about one week. The goal is to learn if this approach is easy to complete, well tolerated, and acceptable to participants. We will also explore whether it is associated with changes in alcohol cravings and drinking.",[29],[138,191],"EEG neurofeedback","2026-07-30",{"date":194,"type":34},"2026-08-04",{"date":196,"type":21},"2026-08-01",{"date":198,"type":21},"2028-02-01",{"name":200,"class":41},"Brigham and Women's Hospital",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":73},"100649509","tris-contingency-management-app-for-alcohol-use-disorder-100649509","NCT07735585","TRIS: Contingency Management App for Alcohol Use Disorder","Remote Treatment With Incentives for Sobriety (TRIS): A Randomized Controlled Trial of a Contingency Management App for Alcohol Use Disorder","Inclusion Criteria:\n\n* Able to read and speak Portuguese.\n* Provide signed informed consent.\n* Age 18 to 70 years.\n* Alcohol consumption within the past month.\n* Current diagnosis of Alcohol Use Disorder (AUD).\n* Seeking treatment for AUD at AME Vila Maria or Instituto Perdizes.\n* Breath alcohol concentration (BrAC) of 0.00 at the time of consent.\n* Own and be able to operate a smartphone with an active mobile service plan.\n* Smartphone compatible with the Bluetooth frequency required for the BACtrack breathalyzer.\n\nExclusion Criteria:\n\n* Crack cocaine use within the past 90 days.\n* Any seizure episode within the past 12 months.\n* Diagnosis of a psychotic disorder (DSM-5).\n* Suicide attempt within the past two years.\n* Any medical or psychiatric condition that may compromise safe participation, as determined by the study medical director.","70 Years",{"count":210,"type":21},130,[187],"Alcohol Use Disorder (AUD) is a major public health concern associated with substantial morbidity, mortality, and impaired social and occupational functioning. Contingency Management (CM) is an evidence-based behavioral intervention that provides incentives contingent on abstinence and has demonstrated effectiveness in the treatment of substance use disorders. This study will evaluate the efficacy of Tratamento Remoto com Incentivos à Sobriedade (TRIS), a Brazilian mobile health application that integrates a smartphone app with a Bluetooth-enabled breathalyzer (BACtrack) to deliver remote CM for AUD. Participants will be randomized to receive either standard outpatient treatment plus TRIS-based CM or standard outpatient treatment with remote alcohol monitoring only. The primary objective is to determine whether TRIS-based CM increases biochemically verified alcohol abstinence compared with standard outpatient treatment alone.",[29],[138,215,216],"Contingency Management","Sobriety","2026-07-27",{"date":192,"type":34},{"date":220,"type":34},"2026-02-19",{"date":222,"type":21},"2027-12",{"name":224,"class":41},"University of Sao Paulo General Hospital",{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":73},"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 in HV s, and nicotine, cannabis or alcohol for AUD participants).\n21. 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.\n22. \\*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":233,"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.",[29],[238,239,29,240,241],"Tirzepatide","Dopamine","Normal Physiology","GLP-1","2026-07-25",{"date":244,"type":34},"2026-07-28",{"date":246,"type":34},"2026-05-20",{"date":248,"type":21},"2031-12-31",{"name":121,"class":122},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":42},"100649351","phase-2-pregnenolone-treatment-for-alcohol-use-disorder-and-major-depressive-disorder-100649351","NCT07734701","Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder","Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy","PREG-AUD-RO1","Inclusion Criteria:\n\n* Age 21 to 55 years.\n* Meets DSM-5 criteria for Alcohol Use Disorder (AUD).\n* Meets DSM-5 criteria for Major Depressive Disorder (MDD).\n* Able to provide informed consent.\n* Willing and able to comply with study procedures and assessments\n\nExclusion Criteria:\n\n* Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder.\n* Current substance use disorder requiring immediate treatment other than alcohol or nicotine.\n* Significant unstable medical or neurologic illness that would interfere with participation or study assessments.\n* Contraindications to magnetic resonance imaging (MRI).\n* Current pregnancy or breastfeeding.\n* Current use of medications or treatments that would interfere with study participation or interpretation of results.\n* Significant suicide risk requiring a higher level of care.\n* Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.","55 Years",{"count":260,"type":21},100,[53],"This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.",[29,264],"Major Depressive Disorder (MDD)",[266,138,267,268,269,270,271],"Pregnenolone","Major Depressive Disorder","Neurosteroids","fMRI","Anxiety","Substance Use Disorders","2026-07-23",{"date":274,"type":34},"2026-07-29",{"date":276,"type":21},"2026-10",{"date":278,"type":21},"2031-03",{"name":280,"class":41},"Sherwood Brown, MD, PhD",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":73},"100647505","body-focused-mindfulness-as-an-add-on-intervention-in-inpatient-alcohol-use-disorder-treatment-mbi-aud-pl-100647505","NCT07706660","Body-Focused Mindfulness as an Add-on Intervention in Inpatient Alcohol Use Disorder Treatment (MBI-AUD-PL)","Effects of a Body-Focused Mindfulness Intervention Added to Standard Inpatient Alcohol Use Disorder Treatment on Emotion Regulation, Interoceptive Awareness, and Alcohol Craving: A Randomized Controlled Trial","MBI-AUD-PL","Inclusion Criteria:\n\n* Diagnosis of Alcohol Use Disorder (DSM-5)\n* Currently admitted to the inpatient AUD treatment program at the study ward\n* Age 18 years or older\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Refusal to participate or withdrawal of consent\n* Severe somatic condition precluding participation in group activities\n* Current acute psychotic symptoms\n* Severe affective symptoms requiring intensive intervention\n* High current suicide risk\n* Epileptic seizure within 2 weeks prior to randomization\n* Intellectual disability or significant cognitive impairment preventing understanding of or adherence to the study protocol\n* Severe personality disorder with current self-harm or other-harm behaviors",{"count":290,"type":21},240,[187],"The goal of this clinical trial is to learn if a body-focused mindfulness program can help people with alcohol use disorder (AUD) feel more connected to their bodies and manage their emotions better. The main questions it aims to answer are:\n\nDoes the mindfulness program reduce feelings of disconnection from the body (bodily dissociation)? Does it improve awareness of body signals (interoceptive awareness)? Does it lower alcohol craving and reduce the chance of returning to drinking after leaving the hospital? Researchers will compare participants who receive the mindfulness program to participants who receive standard psychoeducation sessions, within the same overall inpatient AUD treatment program.\n\nParticipants will:\n\n* Take part in 6 weekly group sessions (90 minutes each) of body-focused mindfulness, which includes breathing exercises, body scan, gentle movement, and group discussion.\n* Receive audio recordings of guided mindfulness exercises to practice independently between sessions.\n* Complete questionnaires about their emotions, body awareness, and alcohol craving before and after the program.\n* Be followed up at 4 weeks, 6 months, and 12 months after leaving the hospital to track their drinking.",[29,84],[295,296,297,298,299,300,301,302,303,304],"mindfulness","body-focused mindfulness","interoception","bodily dissociation","emotion regulation","alexithymia","inpatient treatment","alcohol use disorder","body awareness","randomized controlled trial","2026-07-11",{"date":307,"type":34},"2026-07-16",{"date":309,"type":21},"2026-07-01",{"date":311,"type":21},"2029-12-01",{"name":313,"class":41},"Medical University of Warsaw",{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100646201","prevention-of-relapse-through-cognitive-cycling-in-patients-with-alcohol-use-disorder-following-alcohol-withdrawal-100646201","NCT07690423","Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal","Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial","TUA-VelCo","Inclusion Criteria:\n\n* adults aged ≥ 18 years\n* patients with a diagnosis of alcohol use disorder (AUD) according to DSM-5 criteria\n* who have been hospitalized for complex withdrawal and aim to maintain abstinence after discharge\n* patients must have preserved cognitive function, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 26\n* patients must provide written informed consent\n\nExclusion Criteria:\n\n* pregnant women\n* patients with unstable psychiatric or somatic conditions\n* with a contraindication to physical activity\n* participants in structured rehabilitation programs during the first month\n* adult under guardianship\n* with inability to understand French or provide informed consent\n* with major neurocognitive disorder\n* with regular physical activity\n* participation in another interventional study interfering with outcomes",{"count":323,"type":21},128,[187],"TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for Alcohol Use Disorder (AUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention group or a control group.\n\nParticipants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge.\n\nThe primary outcome will be the proportion of participants maintaining abstinence at M1. Secondary outcomes include maintenance of abstinence at M3 and within-group and between-group changes in craving, cognitive functioning, insight, psychiatric symptoms, and motivation to maintain abstinent. These outcomes will be assessed using validated scales, including the Obsessive Compulsive Drinking Scale, Montreal Cognitive Assessment, Hanil Alcohol Insight Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Biomarkers related to alcohol consumption and neuroplasticity will also be evaluated.",[327,29,328],"Cognitive Cycling","Treatment","2026-07-08",{"date":331,"type":34},"2026-07-10",{"date":329,"type":21},{"date":334,"type":21},"2027-12-01",{"name":336,"class":41},"Centre Hospitalier Esquirol",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":42},"100571982","phase-2-study-of-tirzepatide-for-recovery-and-alcohol-use-management-100571982","NCT06727331","Study of Tirzepatide for Recovery and Alcohol Use Management","Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial","STREAM","Inclusion Criteria:\n\n* English speaking adults aged 18 and above\n* Diagnosed with current DSM-5 alcohol use disorder\n* Willing and able to physically travel to BWH CCI outpatient facilities for study visits\n\nExclusion Criteria:\n\n* CIWA score at screening ≥ 8.\n* Psychotic disorder, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent\n* Any lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating, or avoidant\u002Frestrictive food intake disorder\n* BMI\\\u003C23 mg\u002Fkg2\n* Current or lifetime diagnosis of Type 1 or Type 2 diabetes\n* Current (or within 30 days of enrollment) use of any anti-obesity medications or medications with glucose lowering properties (including GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, or sodium-glucose cotransporter-2 (SGLT-2) inhibitors)\n* Use of any GLP-1 agonist medications in the prior 3 months\n* Anticipating receipt of any other GLP-1 agonist medications during the trial\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* Current hypoglycemia as indicated by a blood sugar level of ≤70 mg\u002FdL measured at the baseline visit\n* Calcitonin ≥ 50 ng\u002FL\n* Triglycerides ≥500 mg\u002FdL\n* Untreated cholelithiasis or gallbladder disease\n* Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days\n* Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of \\>180\u002F110 after three successive readings\n* History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy\n* Liver function test greater than 5 times upper normal limit\n* Renal impairment as indicated by eGFR of \\\u003C30\n* History of hypersensitivity or allergy to tirzepatide\n* Pregnant or breastfeeding\n* Anticipated to be enrolled in another clinical drug trial during participation in this trial\n* Any other reason or clinical condition that the investigators judge may interfere with study participation and\u002For be unsafe for a participant",{"count":346,"type":21},20,[53],"This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.",[29],"2026-07-07",{"date":352,"type":34},"2026-07-09",{"date":354,"type":34},"2025-09-15",{"date":356,"type":21},"2027-07-01",{"name":200,"class":41},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":73},"100453234","phase-2-pharmaceutically-enhanced-reinforcement-for-reduced-alcohol-and-smoking-100453234","NCT05181891","Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking","PERRAS","Inclusion Criteria:\n\n1. 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days\n2. Seeking AUD treatment\n3. Seeking smoking cessation treatment\n4. Aged 18+ years\n5. DSM-5 diagnosis of AUD\n6. Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)\n7. Ability to read and speak English\n8. Ability to provide written informed consent\n9. Breath alcohol of 0.00 during informed consent\n10. Provision of at least 1 EtG-positive urine test at any time during the induction period and at least one COT-positive urine test at any time during the induction period; and\n11. Attended at least 4 of 6 possible visits during the induction period.\n\nExclusion Criteria:\n\n1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal\n2. Currently receiving any pharmacotherapy for alcohol\n3. Currently receiving any pharmacotherapy for smoking\n4. No suicide attempt in the last 20 years and\n5. Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.",{"count":366,"type":21},205,[53],"Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.",[29,370],"Nicotine Use Disorder",[138,215,372,373,370],"Incentives for Sobriety","Varenicline",{"date":375,"type":34},"2026-07-06",{"date":377,"type":34},"2022-07-11",{"date":379,"type":21},"2027-05-01",{"name":381,"class":41},"Washington State University",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":73},"100637042","optimizing-smart-technology-for-addiction-recovery-100637042","NCT07573540","Optimizing Smart Technology for Addiction Recovery","Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder","STAR","Inclusion Criteria:\n\n* meet criteria for alcohol use disorder with at least moderate severity (\\>= 4 DSM-5 criteria)\n* in initial remission with most recent use of alcohol between 1 week and 3 months in the past\n* able to read English\n* have a smartphone and cellular plan that supports STAR use (Apple iOS or Android)\n\nExclusion Criteria:\n\n* medical or psychiatric co-morbidities that preclude use of a smartphone",{"count":391,"type":21},416,[187],"The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:\n\n* help people to improve their health\n* make changes in people's lives to address alcohol and substance use\n\nParticipants will:\n\n* complete surveys\n* use a recovery-support digital therapeutic system",[138,29],"2026-06-22",{"date":397,"type":34},"2026-06-25",{"date":399,"type":34},"2025-09-24",{"date":401,"type":21},"2029-07-31",{"name":403,"class":41},"University of Wisconsin, Madison",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":42},"100568272","phase-2-suvorexant-for-treatment-of-aud-and-ptsd-100568272","NCT06679062","Suvorexant for Treatment of AUD and PTSD","A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","SUV","Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7\u002F-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s\u002Fhe will lose his\u002Fher housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7\u002F-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\\u003C moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.",{"count":413,"type":21},76,[53],"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.",[29,417,418],"Post Traumatic Stress Disorder (PTSD)","Insomnia","2026-06-18",{"date":421,"type":34},"2026-06-23",{"date":423,"type":34},"2025-07-16",{"date":425,"type":21},"2027-03",{"name":427,"class":41},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":437,"briefSummary":438,"conditions":439,"keywords":443,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":73},"100614420","deaf-cbt-ts-to-reduce-suicide-risk-100614420","NCT07279363","Deaf CBT-TS to Reduce Suicide Risk","Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals","Inclusion criteria:\n\n* adult (aged 18 years or older)\n* Self-identify as Deaf or hard of hearing (any degree of hearing loss)\n* Primary method of communication is American Sign Language\n* Positive screen for one or more mental health disorders including depression (PHQ-9 \\> 10), anxiety (GAD-7 \\> 10), posttraumatic stress disorder (PCL-5 \\> 31), insomnia (ISI \\> 15), or alcohol use disorder (AUDIT \\> 16)\n* No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report\n* Access to video chat technology with internet and webcam.\n\nExclusion criteria:\n\n* unable to communicate with the researcher in American Sign Language\n* current alcohol withdrawal necessitating medical evaluation\n* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)\n* unable to comprehend the nature of the study",{"count":436,"type":21},110,[187],"The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are:\n\n* Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors?\n* Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use?\n* Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress?\n* Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors.\n\nParticipants will:\n\n* Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment.\n* Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months\n* Complete two follow-up assessments in 2 and 4 months.",[440,270,441,418,29,442],"Depression - Major Depressive Disorder","PTSD - Post Traumatic Stress Disorder","Suicide Ideation",[444,445,446,447,448],"Deaf","Mental Health","Treatment-Seeking","Suicide","Cognitive Behavioral Therapy for Treatment-Seeking","2026-06-17",{"date":395,"type":34},{"date":452,"type":21},"2026-09",{"date":454,"type":21},"2029-05",{"name":456,"class":41},"University of Rochester",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":208,"enrollmentInfo":464,"targetDuration":4,"studyType":466,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":73},"100630526","imaging-phosphodiesterase-4b-pde4b-in-people-with-psychiatric-disorders-with-positron-emission-tomography-pet-and-the-radiotracer-18fpf974-100630526","NCT07488819","Imaging Phosphodiesterase 4B (PDE4B) in People With Psychiatric Disorders With Positron Emission Tomography (PET) and the Radiotracer [18F]PF974","Imaging PDE4B in People With Psychiatric Disorders With PET and the Radiotracer [18F]PF974","Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent.\n2. Is able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff.\n3. Men or women, aged 18 to 70, at screening.\n4. In good general health as evidenced by medical history, physical examination, electrocardiogram, serum\u002Furine biochemistry, hematology, and serology tests.\n5. Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (SCID-5) ascertained diagnosis, confirmed by the Principal Investigators).\n6. Participants with AUD will meet the following drinking criteria: males will drink \\> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \\> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake.\n7. Participants with PTSD will have a current diagnosis of PTSD according to DSM-5 criteria (CAPS-5 ascertained diagnosis, confirmed by the Principal Investigators. TC subjects must have a DSM-5 criteria traumatic event with no PTSD diagnosis.\n8. Healthy control subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., \\>4 drinks\u002Fday for men; \\>3 drinks\u002Fday for women) in the last 30 days. Subjects who have have a DSM-5 criteria traumatic event with no PTSD diagnosis may also be considered healthy controls for Aim 1.\n9. Renal function and hepatic function will be within normal limits (for age and sex) on the laboratory tests. Elevated liver enzymes for individuals with alcohol use disorder are permitted at the discretion of the study physician.\n\nExclusion Criteria:\n\n1. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary).\n2. Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder.\n3. Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\\*) and past or current psychotic symptoms.\n4. Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data; No subject will be asked to stop taking medication to participate in the study. Participants who are regularly taking P-gp and BCRP inhibitors will be excluded.\n5. Pregnancy or lactation.\n6. Blood donation within eight weeks of the start of the study.\n7. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).\n8. Unable to safely discontinue or hold aspirin and other NSAID use.\n9. MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects\u002Ffragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).\n10. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers.\n11. Subject who has current, past, or anticipated exposure to radiation in the work place within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.\n12. Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.\n13. History of complicated alcohol withdrawal including history of delirium tremens; seizure, hospitalization for withdrawal.\n14. A CIWA score ≥8 at intake or on scan day.\n15. Subjects who are, in the opinion of the study physician, unable to safely abstain from alcohol overnight prior to their study visits.\n16. Subjects with a significant history of repeated alcohol withdrawal, defined as 4 or more medicated detoxifications in the previous 5 years",{"count":465,"type":21},160,"OBSERVATIONAL","Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer \\[18F\\]PF974",[469,29],"Post-Traumatic Stress Disorder, PTSD","2026-06-10",{"date":472,"type":34},"2026-06-11",{"date":474,"type":34},"2025-07-07",{"date":476,"type":21},"2032-03-01",{"name":40,"class":41},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":485,"minAge":100,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":4},"100566255","effectiveness-of-nurse-conducted-brief-intervention-ncbi-supplemented-with-mobile-for-preventing-alcohol-use-disorders-100566255","NCT06652802","Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile for Preventing Alcohol Use Disorders","Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile-based Application for Monitoring and Relapse Prevention in Patients With Alcohol Use Disorders: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients.\n* Aged between 18 and 59 years.\n* Diagnosis of alcohol dependence use disorder based on ICD-10 criteria.\n* Patients with an Android smartphone and the ability to use mobile application.\n\nExclusion Criteria:\n\n* Female patients\n* Comorbid other substance abuse, except tobacco.\n* Comorbid major mental illness \u002Fphysical illness.","MALE","59 Years",{"count":488,"type":21},74,[187],"The study is aimed to find out that combining Nurse-Conducted Brief Intervention (NCBI) with a Smart Mobile is better than Nurse-Conducted Brief Intervention (NCBI) only in preventing relapse among Alcohol Use Disorder patients. The high relapse rates among alcohol disorder patients may be benefitted by new technology using application for improved outcomes in managing and preventing alcohol addiction relapse.",[29],[493,494,495,496,497],"Alcohol Use Disorders (AUDs),","A Randomized controlled trial","Gastroenterology,","CIWA,","Nurse-Conducted Brief Intervention (NCBI)","2026-06-03",{"date":500,"type":34},"2026-06-05",{"date":502,"type":21},"2026-12-01",{"date":504,"type":21},"2028-06-30",{"name":506,"class":41},"University of Pittsburgh",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":466,"phases":4,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":4},"100637543","high-intensity-use-of-urgent-and-emergency-care-a-mixed-methods-study-100637543","NCT07630012","High Intensity Use of Urgent and Emergency Care: A Mixed-Methods Study","High Intensity Use of Urgent and Emergency Care: a Mixed-methods Study Exploring Needs, Experiences and Priorities to Co-produce a Preventative Intervention Model","Inclusion Criteria:\n\nAdults aged 18 or over who have been identified as experiencing high intensity use of urgent and emergency care services at University Hospitals Dorset, defined as five or more unplanned contacts within a 12-month period Adults aged 18 or over who provide unpaid care or support to someone who experiences high intensity use of urgent and emergency care services Health and social care professionals aged 18 or over involved in urgent and emergency care pathways at University Hospitals Dorset, Dorset HealthCare, Dorset Council or voluntary sector partner organisations Able to provide informed consent Willing to take part in an audio-recorded interview-\n\nExclusion Criteria:\n\nUnder 18 years of age Unable to provide informed consent Currently experiencing an acute mental health crisis requiring immediate clinical intervention Known history of violence or aggression towards health and social care professionals Currently receiving inpatient treatment at the time of recruitment No direct involvement in urgent and emergency care pathways at the participating organisations (professionals only)",{"count":515,"type":21},80,"This study aims to understand the health and social care needs and experiences of adults who frequently use urgent and emergency care services in Dorset. Using a mixed-methods design, the study combines analysis of non-patient-identifiable business intelligence data with qualitative interviews and co-production activities. The business intelligence data contextualises patterns of high intensity service use and informs participant identification. Qualitative interviews will explore the personal, social and system-level factors that contribute to frequent attendance. Co-production activities with an advisory group, supported by The Lantern Trust in Weymouth, will use these findings to develop a preventative intervention model grounded in lived experience. The study will recruit up to 50 patients, up to 10 carers and up to 20 health and social care professionals. The findings will contribute to the development of more effective, person-centred approaches to supporting people who frequently use urgent and emergency care services and will inform national and local policy in this area.",[518,519,520,445,29],"High Intensity Use of Urgent and Emergency Care","Emergency Medicine","Health Inequalities",[522,523,524,525,526,527,528,529],"High intensity use","Frequent attenders","Urgent and emergency care","Mixed methods","Co-production","Qualitative research","Health and social care needs","Preventative intervention","2026-06-01",{"date":500,"type":34},{"date":533,"type":21},"2026-09-01",{"date":535,"type":21},"2029-04-01",{"name":537,"class":41},"Bournemouth University",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":466,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100636864","identification-and-molecular-characterisation-of-urban-environmental-stress-patterns-affecting-mental-illness-100636864","NCT07571226","Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness","Inclusion Criteria:\n\n1. Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;\n2. Patients with mental disorders aged 18-60 years, with a balanced gender ratio;\n3. Normal intelligence and ability to use a smartphone running the Android operating system;\n4. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n5. Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score \\>7 or a Hamilton Anxiety Rating Scale (HAMA-14) score \\>7.;\n6. Voluntary participation in this study and signing of informed consent;\n7. For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.\n\nInclusion Criteria for Healthy Control Group\n\n1. Healthy subjects aged 18-60 years, with a balanced gender ratio;\n2. Normal intelligence and ability to use a smartphone running the Android operating system;\n3. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n4. Voluntary participation in this study and signing of informed consent.\n\nExclusion Criteria:\n\n1. Currently taking opioid medications;\n2. Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;\n6. HAMD-17 item 3 (suicide) \\>3 points (severe suicidal behavior);\n\nExclusion Criteria for Healthy Control Group\n\n1. Currently using benzodiazepines or opioid medications;\n2. Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers, or not reaching steady-state drug concentration before the study;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.","60 Years",{"count":546,"type":21},680,"Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space.\n\nThis study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the \"'StreetMind'\" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses.\n\nThe study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.",[264,549,29],"Anxiety Disorder","2026-05-31",{"date":498,"type":34},{"date":553,"type":34},"2026-04-10",{"date":555,"type":21},"2029-05-30",{"name":557,"class":41},"Huashan Hospital",3,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":49,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":42},"100639603","evaluation-of-a-virtual-reality-based-version-of-the-multiple-errands-test-in-alcohol-use-disorder-100639603","NCT07593664","Evaluation of a Virtual Reality-based Version of the Multiple Errands Test in Alcohol Use Disorder","Evaluation of a Virtual Reality-based Version of the Multiple Errands Test for the Assessment of Executive Functions in Alcohol Use Disorder","EVIMETAL","Inclusion Criteria:\n\n* written consent\n* Normal or corrected vision and hearing\n* Membership or entitlement to a social security plan\n* spoken and written French\n* third party liability insurance\n\nfor patients only :\n\n* at least 6 criteria for AUD based on the Diagnostic and statistical manual of mental disorders\n* At the end of withdrawal: treatment with a diazepam equivalent of ≤ 20 mg\u002Fday\n\nExclusion Criteria:\n\n* under tutorship\u002F judicial protection\n* Sensory or motor impairment (impeding the use of virtual reality and\u002For mobility)\n* Severe neurological disorder (such as dementia or Korsakoff's syndrome)\n* Photosensitive epilepsy (contraindication for the use of virtual reality)\n* Any other condition deemed incompatible with the study, at the investigator's discretion\n* Montreal Cognitive Assessment (MoCA) score \\\u003C 10 (severe cognitive impairment)\n* Breastfeeding or pregnant women\n* Familiarity with the supermarket visited during the MET test\n\nFor controls only :\n\n* History of alcohol use disorder\n* score ≥ 8 on the Alcohol Use Disorders Identification Test\n* Score on the Frontal Assessment Battery \\\u003C 16 (or \\\u003C 15 if education is below secondary level)",{"count":132,"type":21},[187],"The goal of this study is to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive functions in patients with alcohol use disorder (AUD).\n\nMore specifically, the project aims to:\n\n1. evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD.\n2. establish whether the virtual version of the test is sensitive enough to detect patients with or without an executive function deficit.\n\nAll participants will perform the original version (in a real-life supermarket) and the virtual version of the test (in a virtual reality environment).\n\nPerformance in the two versions of the test will be compared. Participants will also complete a battery of neuropsychological tests and questionnaires.",[29],[572,573,574,138],"Multiple Errands Test","Executive functions","Virtual reality","2026-05-18",{"date":246,"type":34},{"date":578,"type":21},"2026-05",{"date":580,"type":21},"2028-06",{"name":582,"class":41},"Hôpital le Vinatier",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":99,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":598,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":558},"100577854","metabolome-and-gut-microbiome-changes-during-smoking-cessation-in-long-term-drug-therapy-in-a-therapeutic-community-100577854","NCT06803706","Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community","Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness to quit smoking\n* willingness and ability to consent\n\nInclusion criteria for healthy controls :\n\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness and ability to consent\n\nExclusion Criteria:\n\n* lack of consent, inability to provide informed consent\n* age below 18,\n* acute psychotic symptoms or acute suicidal tendencies\n* cardiovascular disease\n* pregnancy or breastfeeding\n* severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score \\\u003C20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy)\n* probiotic intake within the last 6 months,\n* ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study\n* prior participation in a smoking cessation programme",{"count":591,"type":21},150,[187],"Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.\n\nObjectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.\n\nMethods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.\n\nA cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.",[595,29,596,597],"Substance Use Disorder (SUD)","Nicotine Addiction","Healthy Adult Participants",[599,600,601,602,603],"Metabolomics","Gut microbiome","Substance use disorder","nicotine addiction","smoking cessation","2026-05-15",{"date":575,"type":34},{"date":607,"type":34},"2025-05-05",{"date":609,"type":21},"2026-10-28",{"name":611,"class":41},"Sigmund Freud PrivatUniversitat",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":73},"100589054","assessing-the-impact-of-dtms-on-neural-targets-associated-with-alcohol-use-disorder-100589054","NCT06949423","Assessing the Impact of dTMS on Neural Targets Associated With Alcohol Use Disorder","Accessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder","NEST-A","Inclusion Criteria:\n\n* Age 18-75.\n* Current DSM-5 diagnosis of moderate to severe AUD (\\≥4 diagnostic symptoms).\n* Ability to obtain a Motor Threshold (MT) will be determined during the screening process.\n* Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.\n* Able to read, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.\n* If on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.\n* Fluency in English.\n\nExclusion Criteria:\n\n* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device\u002Fobjected in the head and body within 30 cm of the treatment coil.\n* General medical condition, disease or neurological disorder that interferes with the assessments or participation.\n* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.\n* Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.\n* Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder.\n* A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.\n* Severe impediment to vision, hearing and\u002For hand movement, likely to interfere with the ability to follow study protocols.\n* Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).\n* Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold\n* Acute or unstable chronic illness.\n* Current or lifetime history of bipolar disorder or psychosis",{"count":260,"type":21},[187],"The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.",[29,624],"Transcranial Magnetic Stimilation",[626,627,628,629],"Veterans","Deep Transcranial Magnetic Stimulation (dTMS)","Neuroimaging","Relapse","2026-05-12",{"date":604,"type":34},{"date":633,"type":34},"2025-12-17",{"date":635,"type":21},"2030-06-30",{"name":637,"class":41},"Stanford University",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":646,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":649,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":660,"leadSponsor":662,"locationsCount":4},"100599726","testing-a-music-listening-mhealth-intervention-for-stress-reduction-in-early-recovery-calmify-ii-100599726","NCT07088237","Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery (CalmiFy II)","Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery","CalmiFy II","Inclusion Criteria:\n\n* Subject can and has signed an Institutional Review Board (IRB) approved informed consent form (ICF).\n* Age ≥18 and ≤35 years.\n* In early-stage recovery for alcohol use (within 12 months)\n* Own a smartphone with a data plan\n* Not experiencing symptoms of severe depression\n* Not experiencing thoughts of suicide\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for alcohol use disorder (AUD)\n* Not currently taking medication treatment for opioid use disorder (OUD)\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Currently experiencing symptoms of severe depression\n* Currently experiencing thoughts of suicide\n* Currently taking medication treatment for opioid use disorder (OUD)\n* Are unable to provide voluntary informed consent.\n* Cannot read or speak English.","35 Years",{"count":648,"type":21},30,[187],"The overarching goal of this study is to develop and examine the feasibility of a music-listening intervention that can be deployed in \"real time\" to regulate emotions and reduce momentary stress among young adults within the first 12 months of recovery from alcohol use disorder. The investigators design the study with two phases to address three aims: Phase I includes the first two aims. For Aim 1, the investigators will conduct formative research with a sample of young adults who have are within 12 months of recovery (N = 30) to identify features of music selections that are most effective in reducing momentary stress in real-world, ambulatory settings. For Aim 2, the investigtors will focus on developing mobile health technology that uses passive sensing and machine learning to automatically predict moments of heightened stress in real-time and suggest specific musical selections when stress is detected. During Phase II (Aim 3), the investigators will test the feasibility of a novel music-listening intervention among a second unique sample of young adults who are within 12 months of recovery from AUD (N = 30). This protocol refers only to Phase II of the larger study.",[29],[653,302,654,655],"recovery","stress","music listening","2026-04-29",{"date":658,"type":34},"2026-05-05",{"date":502,"type":21},{"date":661,"type":21},"2028-03-01",{"name":381,"class":41}]