[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-use-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-use-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,186,0,25,[9,46,72,99,119,143,153,163,186,210,233,255,293,321,347,368,389,413,436,460,478,498,528,549,578],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054081","phase-2-combination-therapy-for-alcohol-use-disorder-100054081",false,"NCT07249554","Combination Therapy for Alcohol Use Disorder","Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n* Aged 21-65 years old\n* Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.\n* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder\n* Willing to comply with the study protocol\n\nExclusion Criteria:\n\n* Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization\n* Currently pregnant, breastfeeding\n* Unwilling to use contraceptives (e.g., condoms and\u002For hormonal birth control)\n* Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder\n* History of pancreatitis\n* History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.\n* Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy\n* Levels of amylase, lipase, aspartate aminotransferase (AST), and\u002For alanine transferase (ALT) greater than 2x upper limit of normal\n* Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide\n* Diagnosis of cancer within past 5 years\n* History of multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Currently taking any medications contraindicated with GLP-1 agonists and\u002For naltrexone.\n* BMI \\\u003C18.5\n* Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.\n* Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).\n* Allergies to semaglutide and\u002For naltrexone\n* Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen\n* Prescribed or taking the following medications in the past four weeks:\n* The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).\n* The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.","ALL","21 Years","65 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.",[28],"Alcohol Use Disorder",[30,31,28,32],"Glucagon-like peptide 1","Naltrexone","Addiction","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":22},"2026-09",{"date":41,"type":22},"2028-09",{"name":43,"class":44},"Johns Hopkins University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100053269","hepatic-lipid-metabolism-alcohol-use-disorder-100053269","NCT07191561","Hepatic Lipid Metabolism-Alcohol Use Disorder","Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Any individual \\>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.\n* Vibration Controlled Elastography parameters with initial CAP of \\>295dB\u002Fm.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy\n* Existing diagnosis of hyperlipidemia or essential hypertension\n* Hemoglobin A1c \\>= 6.5%\n* Waist to hip ratio: \\>=0.90 in males, \\>=0.85 in females\n* Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.\n* Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \\> 32\n* Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)\n* HIV infection\n* Contraindication or inability to perform a liver biopsy.\n\n  * Participants with coagulopathy (PT\u002FPTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.\n  * Hemoglobin level \\\u003C 11 g\u002FdL\n  * Inability to provide informed consent.","18 Years","100 Years",{"count":7,"type":22},"OBSERVATIONAL","Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,",[28],[60,61,62],"Alcohol","Liver","Biopsy","RECRUITING",{"date":36,"type":37},{"date":66,"type":22},"2026-07-16",{"date":68,"type":22},"2029-11-30",{"name":70,"class":71},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":79,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":45},"100053742","the-effect-of-comorbid-alcoholsubstance-use-100053742","NCT07692984","The Effect of Comorbid Alcohol\u002FSubstance Use","The Effect of Comorbid Alcohol\u002FSubstance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria,\n* Being actively followed up at the TRSM for at least 6 months.\n\nExclusion Criteria:\n\n* Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),\n* Individuals with severe cognitive impairment that prevents them from communicating adequately.",{"count":80,"type":22},297,"Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.\n\nAim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.\n\nResearch Questions\n\nWhat are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?\n\nHypotheses\n\nH1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.\n\nH2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.\n\nH3: Social inclusion is lower among patients with substance use compared with the control group.\n\nH4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.\n\nH5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.\n\nH6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.",[83,28,84,85,86,87,88],"Alcohol Abuse","Substance Use Disorders","Severe Mental Disorder","Schizophrenia","Bipolar Disorder","Ostracism",[90,84,85,91],"alcohol use disorder","ostracism",{"date":36,"type":37},{"date":94,"type":37},"2026-06-20",{"date":96,"type":22},"2026-12-30",{"name":98,"class":44},"Abant Izzet Baysal University",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":45},"100054050","phase-1-environment-and-alcohol-a-pilot-study-100054050","NCT06860607","Environment and Alcohol: A Pilot Study","* INCLUSION CRITERIA:\n\nTo meet eligibility for this study, participants must meet all the following criteria:\n\n1. At least 21 years old\n2. Owns a cellular device (\"smart phone\") and is willing to download the EMA application and use it to answer the study questionnaires\n3. Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n4. Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \\> 7 drinks per week for females or \\> 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with \\> 3 drinks for females or \\> 4 drinks for males during the 28-day period prior to screening\n5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\\u003C 10\n6. If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.\n\nEXCLUSION CRITERIA:\n\nAny individual who meets any of the following criteria will be excluded from this study:\n\n1. Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD\n2. Medical and\u002For mental health conditions that are clinically unstable and would therefore compromise the safety and\u002For scientific integrity of the study, as determined by the MAI or study team respectively.\n3. Known history of clinically significant cybersickness.\n4. Any other reason or clinical condition that the Investigators judge would interfere with study participation and\u002For be unsafe for a participant\n5. Unable to speak, read, write, and understand English\n\nJustification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study.",true,{"count":107,"type":22},44,[109],"PHASE1","Background:\n\nAlcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes.\n\nObjective:\n\nTo evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD.\n\nDesign:\n\nParticipants will have up to 10 study visits in Baltimore.\n\nParticipants will have a baseline visit. They will have a physical exam with blood and urine tests. They will have a breath test for alcohol and a test that measures body composition. They will answer questions about their alcohol and substance use; mental and physical health; mood and anxiety; and sleep quality.\n\nParticipants will download an app called MetricWire. The app will send 3 sets of questions to be answered at different times throughout the day.\n\nThe study visits will include 2 stages:\n\n1. Active stage. On these visits, participants will use a virtual reality system called the Meta Quest Pro (MQP) as they choose. Then they may choose among video games, puzzles, books, crafts, and other activities.. These sessions will last for 3 hours.\n2. Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.\n\nOn the last visit of each stage, participants will sit in a room that looks like a bar. They will answer questions about their cravings, their urge to drink, and how many drinks they would buy. Participants will be served 1 drink containing alcohol. They will be asked about their cravings and subjective effects of alcohol after drinking it.",[28],[28],{"date":36,"type":37},{"date":66,"type":22},{"date":116,"type":22},"2028-03-01",{"name":118,"class":71},"National Institute on Drug Abuse (NIDA)",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":45},"100610827","impact-of-federal-and-state-medications-for-opioid-use-disorder-moud-policy-changes-during-the-pandemic-100610827","NCT07232641","Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic","Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder","IMPACT","Inclusion Criteria:\n\n* Substance use disorder (alcohol and\u002For opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)\n\nExclusion Criteria:\n\n* None",{"count":128,"type":22},185810,"\"Gold-standard\" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide \"whole-patient\" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent.\n\nThis study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.",[84,28,131],"Opioid Use Disorder",[133],"Medications for opioid use disorder (MOUD)","2026-07-01",{"date":136,"type":37},"2026-07-02",{"date":138,"type":37},"2026-06-30",{"date":140,"type":22},"2029-09",{"name":142,"class":44},"Boston University",{"id":144,"slug":4,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":145,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":146,"keywords":147,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":45},"100607669",{"count":7,"type":22},[28],[60,61,62],{"date":136,"type":37},{"date":150,"type":22},"2026-07-07",{"date":68,"type":22},{"name":70,"class":71},{"id":154,"slug":4,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":110,"conditions":157,"keywords":158,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":162,"locationsCount":45},"100582230",{"count":107,"type":22},[109],[28],[28],{"date":136,"type":37},{"date":150,"type":22},{"date":116,"type":22},{"name":118,"class":71},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":45},"100517311","phase-2-semaglutide-therapy-for-alcohol-reduction-star-100517311","NCT06015893","Semaglutide Therapy for Alcohol Reduction (STAR)","Semaglutide Therapy for Alcohol Reduction (STAR): A Proof-of-Concept Phase II Clinical Trial","* INCLUSION CRITERIA:\n\nThis study will enroll adult individuals with a current diagnosis of AUD. Participants will be recruited without any preference to sex, race, religion, or other social variables, but sociodemographic data will be collected for sample characterization and potential use in the analyses. Since self-reported psychological measures that have been validated in English constitute major part of the study assessments, participants need to be able to speak, read, write, and understand English to be in the study.\n\nThe information needed to assess eligibility will be collected under an IRB-approved NIDA IRP\n\nscreening protocol, led by the Office of the Clinical Director (OCD) at the NIDA IRP to assess\n\npotential research participants' eligibility for entering clinical protocols. Additional details can be found in the NIDA screening protocol documents. Furthermore, NIH medical records (from other NIH clinical protocols) and outside medical records may also be used, if available, to determine whether participants fulfill the eligibility criteria.\n\nTo be eligible for this study, an individual must meet all of the following criteria:\n\n* At least 18 years old\n* Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n* Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \\> 7 drinks per week for females or \\> 14 drinks per week for males during the 28-day period prior to screening plus at least four days with \\> 3 drinks for females or \\> 4 drinks for males during the 28-day period prior to screening\n* Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\\u003C 10\n* Able to speak, read, write, and understand English as demonstrated by ability to understand and sign the NIDA screening protocol consent\n* Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from enrolling in this study:\n\n* BMI \\\u003C 23 kg\u002Fm\\^2 or BMI \\>= 50 kg\u002Fm\\^2\n* Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)\n* Most recent blood tests: creatinine \\>= 2 mg\u002FdL, eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2, triglycerides \\> 500 mg\u002Fdl, ALP \\> 4x the upper limit of normal, clinically abnormal lipase levels per study clinician\n* Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) \\>= 6.5 %\n* Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors\n* Current or prior use of semaglutide or tirzepatide\n* Current (within the past 30 days) use of weight-lowering medications\n* Current (within the past 30 days) use of FDA-approved pharmacotherapy for AUD (oral or intramuscular naltrexone, acamprosate, disulfiram)\n* Current (within the past 30 days) use of medications with known interaction with semaglutide\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n* Known ongoing history of alcohol ketoacidosis, gastroparesis, pancreatitis (either acute or chronic), pancreatic carcinoma, gallbladder disease, jaundice, Mallory-Weiss syndrome (esophageal tears secondary to vomiting), esophageal varices, cirrhosis\n* Known history of gastric bypass surgery\n* Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue\n* Known history of suicidal attempts (within the past 24 months) or active suicidal ideation\n* Known history of clinically significant vestibular disorders or motion sickness\n* Known history of clinically significant noise-induced hearing loss or tinnitus\n* Contraindication(s) for brain fMRI\n* Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)\n* Physical and\u002For mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.\n* Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method\n* Any other reason or clinical condition that the investigators judge may interfere with study participation and\u002For be unsafe for a participant","110 Years",{"count":172,"type":22},80,[25],"Background:\n\nAlcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.\n\nObjective:\n\nTo test if a medication named Semaglutide may reduce alcohol drinking in people with AUD.\n\nWho can participate?\n\nAll Adults aged 18 or older with AUD might be eligible to participate in the study.\n\nWhat will happen during the study?\n\nParticipants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit.\n\nParticipants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine.\n\nThe study medication is given as a shot under the skin each week.\n\nParticipants will undergo different tests throughout the study:\n\nThey will give blood, urine, and saliva samples.\n\nThey will engage in self-paced behavioral therapy on a computer.\n\nThey will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc.\n\nThey will taste several sweet liquids and tell their preferences.\n\nThey will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol.\n\nThey will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet.\n\nThey will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen.\n\nParticipants will have a follow-up visit about 7 weeks after their last shot.",[32,28],[60,177,178,179],"Pharmacotherapy","GLP-1","Semaglutide",{"date":136,"type":37},{"date":182,"type":37},"2023-10-17",{"date":184,"type":22},"2030-12-31",{"name":118,"class":71},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":45},"100501275","phase-1-spironolactone-in-alcohol-use-disorder-saud-100501275","NCT05807139","Spironolactone in Alcohol Use Disorder (SAUD)","Spironolactone in Alcohol Use Disorder (SAUD): A Double-Blind, Placebo-Controlled, Ascending Dose, Phase 1b Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to enroll in this study, an individual must meet all of the following criteria:\n\n1. At least 21 years old\n2. Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini- International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n3. At least four days with \\>= 4 drinks for females or \\>= 5 drinks for males during the 28-day period prior to screening, according to alcohol TimeLine Follow Back (TLFB)\n4. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is \\\u003C 10\n5. Able to speak, read, write, and understand English as demonstrated by their ability to understand and sign the consent for the NIDA screening protocol.\n6. Female participants must be postmenopausal for at least one year, surgically sterile, or practicing a highly effective method of birth control before entry and throughout the study and must have negative pregnancy tests at each stage. Examples of highly effective methods of birth control include abstinence, hormonal contraceptives (e.g., certain birth control pills, contraceptive patch, vaginal ring, or implants), intrauterine device (IUD), tubal ligation, or vasectomy.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Most recent blood tests: potassium \\> 5.2 mmol\u002FL; creatinine \\>= 2 mg\u002FdL; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2, hemoglobin A1c (HbA1c) \\> 6.5 %\n2. Clinically significant and\u002For symptomatic hyponatremia, hypomagnesemia, hypocalcemia, and hyperuricemia based on Medical Advisory Investigators (MAI) or designee judgment.\n3. Known history of clinically significant orthostatic hypotension\n4. Known history of hypoaldosteronism, hyperaldosteronism, Addison s disease\n5. Diagnosis of NYHA class III-IV heart failure, or unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)\n6. Current use of any diuretic, angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), potassium supplementation, potassium containing salt substitute, heparin and low molecular weight heparin (LMWH), trimethoprim, lithium, digoxin, cholestyramine\n7. Current use of MR antagonists\n8. Current use of FDA-approved pharmacotherapy for AUD, or seeking treatment for AUD\n9. Known history of prior hypersensitivity reaction to spironolactone or other MR antagonists, or any of the product components\n10. Known history of alcohol withdrawal seizure and delirium tremens.\n11. Physical and\u002For mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.\n12. Pregnancy, intention to become pregnant, or breastfeeding.\n13. Any other reason or clinical condition that the Investigators judge would interfere with study participation and\u002For be unsafe for a participant.","99 Years",{"count":195,"type":22},20,[109],"Background:\n\nAlcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3 medicines have been approved by Food and Drug Administration to treat AUD. Researchers want to find better treatments for AUD. Animal studies found that a medicine called spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is approved to treat high blood pressure, or heart failure in people. It is not approved to treat AUD.\n\nObjective:\n\nTo test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order to understand how the body breaks down spironolactone and if there are any side effects in people who drink alcohol while taking this medicine.\n\nEligibility:\n\nPeople aged 21 and older with AUD.\n\nDesign:\n\nParticipants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months. Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of the medicine. The placebo capsule looks just like the spironolactone capsule but contains no medicine. Participants will not know when they are taking the medicine or the placebo.\n\nParticipants will not drink alcohol until day 6 of each clinic stay. Then they will be asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and their well-being will be measured.\n\nParticipants will undergo other tests in the clinic:\n\nA DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle mass. Participants will lie on an open-top, padded table, then a small arm will scan the full length of their body. The radiation participants will get in this study is about the same as from one regular x-ray.\n\nBlood tests. Participants may feel some discomfort at the site of needle entry.\n\nElectrocardiogram. This test records the heart activity. Sensors are attached to the skin with stickers and removed after a few minutes.\n\nUrine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine.\n\nQuestionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking.",[28],[200,201,28,202,203],"Alcohol Consumption","Alcohol Problems","SPIRONOLACTONE","Mineralocorticoid Receptor",{"date":136,"type":37},{"date":206,"type":37},"2023-07-13",{"date":208,"type":22},"2027-04-30",{"name":118,"class":71},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":105,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":45},"100645066","pomegranate-dietary-supplements-in-aud-and-ald-100645066","NCT07678567","Pomegranate Dietary Supplements in AUD and ALD","Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)","Healthy Group:\n\nInclusion: Healthy individuals, Exclusion: AUD, ALD, AC, and inflammatory conditions,\n\nAlcohol Use Disorder Group:\n\nInclusion: AUD diagnosis Exclusion: alcohol-associated systemic conditions\n\nAlcohol-associated liver disease Group:\n\nInclusion: early-stage ALD comorbid with AUD Exclusion: Only AUD or AUD with AC\n\nAlcohol-associated cirrhosis Inclusion: AC with AUD Exclusion: AUD, and early stage ALD, as well as determined by the study cohort criteria",{"count":218,"type":22},144,"The goal of this project is to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. Recent publications have reported that urolithins are the major active metabolites responsible for the beneficial effects of eating pomegranates, berries, or walnuts. However, the production of urolithins from the parent compound ellagic acid (EA) is dependent upon the presence of certain bacteria in the human gut. In this trial, we propose to investigate variations in gut microbiota and their capacity to metabolize pomegranate dietary supplements (PDS) into active urolithins. We will measure the levels of urolithins in blood as well as inflammatory cytokines in plasma samples upon consumption of PDS.",[28,221,222,223],"Alcohol-associated Liver Disease","Alcoholic Cirrhosis","Healthy",[225],"Pomeragranate, AUD, ALD",{"date":136,"type":37},{"date":228,"type":22},"2027-01-01",{"date":230,"type":22},"2032-12-31",{"name":232,"class":44},"University of Louisville",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100642801","phase-3-efficacy-in-relapse-prevention-psilocybin-in-alcohol-use-disorder-with-depressive-symptoms-100642801","NCT07638553","Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms","ERPPAD","Inclusion Criteria:\n\n* Confirmed DSM-5 diagnosis of severe AUD.\n* Scale BDI-II ((Beck Depression Inventory) ≥14\n* The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient unable to give informed consent.\n* Participants planning to donate sperm within three months of psilocybin administration\n* Positive pregnancy test at inclusion for participants of childbearing age.\n* Patient who is pregnant, breastfeeding, or wishing to become pregnant during participation in the study.\n* Any use of classical psychedelic in the last year\n* Other current substance use disorder (except tobacco)\n* Diagnosed schizophrenic or bipolar disorder\n* High emotional lability (clinician-judged)\n* On antipsychotics treatment that may interfere with psilocybin.\n* Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.\n* Severe suicidal ideation (high risk on the Columbia scale)\n* 1st degree family member with a diagnosed psychotic disorder\n* Severe cognitive impairment (clinician-judged)\n* CIWA-AR \\> 8\n* Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc \\> 470 ms for women and \\>450 ms for men); heart failure; uncontrolled hypertension (greater than 165\u002F95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.",{"count":241,"type":22},172,[243],"PHASE3","Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants.\n\nThe Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \\[0.16-1.65\\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.",[28,246,247],"Depressive Sympotoms","Psilocybin",{"date":134,"type":37},{"date":138,"type":37},{"date":251,"type":22},"2030-06",{"name":253,"class":44},"Centre Hospitalier Universitaire de Nīmes",8,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":45},"100644863","preventing-harmful-alcohol-use-among-trauma-patients-in-cameroon-100644863","NCT07677449","Preventing Harmful Alcohol Use Among Trauma Patients in Cameroon","Implementation of a Culturally Adapted Alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) Program in Cameroon","Inclusion Criteria:\n\n* Adult trauma patients aged 18 years and older presenting to the Emergency Department of Limbe Regional Hospital.\n* Positive alcohol screening based on the Single Alcohol Screening Question (SASQ).\n* AUDIT-C score ≥4 for men or ≥3 for women.\n* Able to provide informed consent.\n* Resident within the study catchment area and available for follow-up.\n* Access to a telephone or another reliable means of contact for follow-up assessments.\n\nExclusion Criteria:\n\n* Severe cognitive impairment preventing participation in study procedures or - provision of informed consent.\n* Severe traumatic brain injury or other medical condition requiring immediate life-saving intervention that precludes participation.\n* Current psychosis or severe psychiatric illness preventing meaningful participation in the intervention.\n* In police custody or other circumstances limiting ability to participate in follow-up.\n* Planned relocation outside the study catchment area during the study follow-up period.\n* Previously enrolled in the study.",{"count":263,"type":22},690,[265],"NA","\\*\\*Brief Summary\\*\\*\n\nAlcohol use is a major contributor to injury burden in Cameroon, particularly among trauma patients presenting to emergency departments. Despite the strong association between alcohol use and injury, structured alcohol screening and intervention programs are not routinely integrated into trauma care in Cameroon. This study aims to evaluate a Cameroon-adapted Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for trauma patients at the Limbe Regional Hospital.\n\nThe study will be conducted in three phases: (1) training emergency department healthcare providers on a culturally adapted SBIRT program; (2) evaluating the feasibility, acceptability, and fidelity of SBIRT implementation in routine emergency care; and (3) assessing the effectiveness of SBIRT in reducing harmful alcohol use among trauma patients. Healthcare workers will be trained to deliver SBIRT, and eligible trauma patients screening positive for risky alcohol use will be enrolled in a randomized waitlist-controlled trial. Participants will undergo alcohol screening using validated tools and will be followed for six months. Outcomes will include alcohol use measured by the Alcohol Use Disorders Identification Test (AUDIT), phosphatidylethanol (PEth) biomarker levels, referral uptake, implementation outcomes, and patient well-being measures.\n\nThe study is expected to generate evidence on the feasibility and effectiveness of integrating alcohol interventions into trauma care in a low-resource setting and inform future scale-up of SBIRT programs in Cameroon and similar settings.",[28,268,269],"Alcohol-Related Injury","Trauma",[271,272,268,273,274,275,276,277,278,279,280,281,282,283,284],"Alcohol Use Disorder (AUD)","Alcohol Screening","Screening, Brief Intervention, and Referral to Treatment (SBIRT)","Brief Intervention","Emergency Department","Trauma Care","AUDIT-C","Referral to Treatment","Substance Use Intervention","Emergency Medicine","Implementation Science","Injury Prevention","Road Traffic Injury","Trauma Patients","2026-06-27",{"date":138,"type":37},{"date":288,"type":22},"2027-03",{"date":290,"type":22},"2030-08",{"name":292,"class":44},"University of Buea",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":105,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":45},"100217453","behavioral-and-functional-task-development-implementation-and-testing-100217453","NCT02108054","Behavioral and Functional Task Development, Implementation, and Testing","* INCLUSION CRITERIA:\n* between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies\\*.\n\nEXCLUSION CRITERIA:\n\n* Are not cleared on a neuromotor examination\n* Are currently receiving psychotropic medication\n* Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the\n\npast 30 days CIWA score \\> 8).\n\n-MRI Exclusion Criteria:\n\n* Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;\n* Are pregnant, as determined by a negative pregnancy test\n* Left handed\n* Claustrophobia.\n\n  * To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.",{"count":300,"type":22},400,[265],"Background:\n\n\\- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.\n\nObjective:\n\n\\- To develop tasks that investigate a person s behavior that can be used in later studies.\n\nEligibility:\n\n* Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old.\n* Healthy right-handed volunteers 18-65 years old.\n\nDesign:\n\n* Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.\n* Participants will have between one and three visits.\n* Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.\n* Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.\n* The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.",[304,305,306,28,32],"Alcohol Dependence","Alcohol Drinking","Alcoholism",[308,306,309,310,311,312,313],"fMRI","Phenotype","Imaging","EEG","Psychophysiology","Near Infrared",{"date":138,"type":37},{"date":316,"type":37},"2014-05-28",{"date":318,"type":22},"2026-12-31",{"name":320,"class":71},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":336,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":45},"100623512","peer-support-for-liver-transplant-recipients-with-history-of-ald-100623512","NCT07397598","Peer Support for Liver Transplant Recipients With History of ALD","Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease","THRIVE","Inclusion Criteria:\n\n* English speakers\n* Received a liver transplant for alcohol-associated liver disease\n* Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry\n\nExclusion Criteria:\n\n* Liver transplant recipients without a history of alcohol-associated liver disease\n* Inability to provide informed consent\n* Active participation in a separate intervention trial for alcohol use disorder",{"count":330,"type":22},95,[265],"Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions:\n\n* Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall?\n* Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?",[28,334,335],"Alcohol Related Liver Disease","Liver Transplant Recipient",[337,334,338,339],"Alcohol use disorder","Liver transplant recipient","Peer support specialist","2026-06-26",{"date":138,"type":37},{"date":343,"type":22},"2026-08",{"date":345,"type":22},"2029-06",{"name":43,"class":44},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":354,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":45},"100645343","phase-2-effects-of-nimodipine-on-alcohol-drinking-100645343","NCT07681869","Effects of Nimodipine on Alcohol Drinking","A Randomized Controlled Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol 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 at least moderate 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 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.\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 nimodipine including untreated or not adequately controlled hypertension or hypotension. Blood pressure at or below 100\u002F65 will be exclusionary.\n7. Heart rate of less than 50 bpm.\n8. 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.\n9. Concurrent use of the following medications: CYP3A4 inhibitors and inducers, other calcium channel blockers, or other blood pressure lowering medications.\n10. 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 PI, may put the patient at risk because of participation in the study.\n11. Clinical Institute Withdrawal Assessment for Alcohol-Revised (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.\n12. Women who are pregnant or nursing.\n13. Participants who refuse to use a reliable method of birth control from the time of first medication administration to 7 days after. These include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring, surgical sterilization, or true abstinence.\n14. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n15. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n16. 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.\n17. Subjects who have donated blood within the past 6 weeks.\n18. Heart rate of less than 50 bpm.\n19. Subjects with a history or presence of cirrhosis.\n20. MRI contraindications including incompatible implants, other metal in body (e.g. pacemakers, shrapnel, metal implants) or claustrophobia.","50 Years",{"count":356,"type":22},40,[25],"This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg\u002Fdose) or placebo every six hours during an 18-hour period prior to each ADP. MEG and\u002For EEG data will be collected before the first dose and after the third dose of nimodipine (NIM) or placebo (PLA). Adverse events will be closely monitored during this period. During the ADP participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as breath alcohol levels. Investigators anticipate having to recruit up to 40 participants to achieve 20 completers.",[28],"2026-06-25",{"date":136,"type":37},{"date":363,"type":22},"2026-09-01",{"date":365,"type":22},"2032-06-30",{"name":367,"class":44},"Yale University",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":45},"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":377,"type":22},416,[265],"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",[28,271],"2026-06-22",{"date":360,"type":37},{"date":384,"type":37},"2025-09-24",{"date":386,"type":22},"2029-07-31",{"name":388,"class":44},"University of Wisconsin, Madison",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":45},"100523038","phase-1-ketamine-for-combined-depression-and-alcohol-use-disorder-100523038","NCT06090422","Ketamine for Combined Depression and Alcohol Use Disorder","Ketamine for Combined Depression and Alcohol Use Disorder: A Blinded Randomized Active Placebo-controlled Trial (the KeDA Trial)","KeDA","Please contact the project team for a full and detailed list of inclusion\u002Fexclusion criteria\n\nInclusion Criteria:\n\n* Currently abstinent from alcohol\n* At least moderate depression without psychotic features\n* Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20\n* Alcohol dependence\n* Admitted for inpatient addiction therapy at University Hospital of North Norway\n\nExclusion Criteria:\n\n* Intoxicated or in significant withdrawal from alcohol or drug use\n* Not able to give adequate informed consent\n* Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder\n* Current or historical diagnosis of schizophrenia in a first degree relative\n* Cardiovascular conditions: recent stroke (\\\u003C 1 year from informed consent), recent myocardial infarction (\\\u003C 1 year from informed consent), uncontrolled hypertension (\\>150\u002F100 mm Hg) or recent arrhythmia (\\\u003C 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)\n* Liver (Child-Pughs Class C) or kidney (Creatinin clearance \\\u003C 30 mL\u002Fmin) failure\n* Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV)\n* Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and\u002For Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher)\n* Previous anaphylactic reaction to ketamine or midazolam\n* Illegal use of ketamine the last 6 months\n* Pregnancy or breastfeeding\n* Current or suspected increased intracranial pressure",{"count":398,"type":22},34,[109,25],"The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.",[402,28],"Depression",[402,337,404,32],"Ketamine",{"date":406,"type":37},"2026-06-23",{"date":408,"type":37},"2025-01-20",{"date":410,"type":22},"2027-07-01",{"name":412,"class":44},"University Hospital of North Norway",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":432,"leadSponsor":434,"locationsCount":45},"100643943","effects-of-olfactory-stimuli-in-virtual-reality-cue-exposure-on-craving-and-attentional-bias-in-alcohol-use-disorder-100643943","NCT07667790","Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder","Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence","OLFA-VR","Inclusion Criteria:\n\n* age between 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* complete inpatient detoxification within the last three months\n* history of alcohol craving\n* capacity to provide written informed consent\n\nExclusion Criteria:\n\n* substance dependences other than alcohol or nicotine\n* current alcohol intoxication (tested by random breath-alcohol measurements)\n* alcohol abstinence less than 7 days or on-going alcohol consumption\n* severe neuropsychiatric disorder (e.g. schizophrenia-spectrum disorder, bipolar affective disorder or substantial cognitive impairment)\n* severe medical conditions affecting brain or heart function that could influence the parameters under investigation\n* acute suicidality or risk of harm to others\n* current pharmacological treatment for alcohol dependence (e.g., benzodiazepines) or for craving (e.g., acamprosate, disulfiram, naltrexone, nalmefene)\n* other medications that may have a significant influence on heart rate\n* sinusitis, self-reported problems with smell, or lack of normosmia, assessed both subjectively and objectively\n* limited ability to understand the study information, the consent form or the study procedures and principles",{"count":422,"type":22},60,[265],"Alcohol use disorder (AUD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol-often accompanied by an attentional bias toward alcohol-related stimuli-which can be evoked by both real-world and virtual stimuli in immersive virtual reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based cue exposure (VR-CE) influence craving and attentional bias in patients with AUD.\n\nThe goal of this prospective experimental single-arm clinical study, with a 2 (visual stimuli: neutral vs. alcohol-related VR scenarios) × 2 (olfactory stimuli: no odor vs. alcohol-related odor) within-subjects factorial design, is to determine how visual and olfactory stimuli contribute to the outcomes during a multimodal VR-CE in patients with AUD.\n\nThe main question is whether VR-CE with concurrent visual and olfactory alcohol-related stimuli induces a greater increase in craving and attentional bias from baseline than exposure to a single modality (visual or olfactory), as assessed by subjective and psychophysiological measures in patients with AUD.",[28],[90,427,428],"virtual reality cue exposure","olfactory","2026-06-21",{"date":360,"type":37},{"date":134,"type":22},{"date":433,"type":22},"2027-07",{"name":435,"class":44},"Charite University, Berlin, Germany",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":459},"100609851","phase-3-a-study-of-brenipatide-in-participants-with-alcohol-use-disorder-100609851","NCT07219953","A Study of Brenipatide in Participants With Alcohol Use Disorder","A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)","RENEW-ALC-2","Inclusion Criteria:\n\n* Participant must be a minimum of 20 years of age for the investigative sites in Japan.\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention.\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).","75 Years",{"count":446,"type":22},1100,[243],"The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.",[28],"2026-06-19",{"date":406,"type":37},{"date":453,"type":37},"2025-10-16",{"date":455,"type":22},"2028-04",{"name":457,"class":458},"Eli Lilly and Company","INDUSTRY",117,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":444,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":477},"100609852","phase-3-a-study-of-brenipatide-in-participants-with-moderate-to-severe-alcohol-use-disorder-100609852","NCT07219966","A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder","A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)","RENEW-ALC-1","Inclusion Criteria:\n\n* Participant must be a minimum of 20 years of age for the investigative sites in Japan.\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).",{"count":446,"type":22},[243],"The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.",[28],{"date":406,"type":37},{"date":474,"type":37},"2025-10-15",{"date":455,"type":22},{"name":457,"class":458},121,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":105,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":484,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":45},"100226932","niaaa-natural-history-protocol-100226932","NCT02231840","NIAAA Natural History Protocol","* INCLUSION CRITERIA:\n\nAs this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:\n\n* Age \\>=18 years of age\n* Willingness to complete the study including genetic and MRI tests.\n\nWe will assign participants to one of two groups in this study:\n\n* Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and\n* Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).\n\nAll participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility.\n\nEXCLUSION CRITERIA:\n\nThis is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:\n\n* Individuals \\\u003C 18 years of age\n* Prisoners\n* Pregnant candidates\n* Candidates having a severe medical or mental health disorder that would impair participation in the study\n\nAll participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study.",{"count":485,"type":22},7500,"Background:\n\n\\- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.\n\nObjective:\n\n-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.\n\nEligibility:\n\n* Adults age 18 and older.\n* Not being pregnant or imprisoned.\n\nDesign:\n\n* Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.\n* Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.\n* Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.\n* Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.\n* After discharge, participants may be called and asked questions about their drinking and health.\n* If participants sign the second consent, they:\n* will complete paper- and computer-based questionnaires.\n* will give blood samples.\n* may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.",[28],[489,490,28,491],"Phenotypes","Genetics","Natural History",{"date":406,"type":37},{"date":494,"type":37},"2015-01-21",{"date":496,"type":22},"2044-12-31",{"name":320,"class":71},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":512,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":527},"100609614","safety-and-effectiveness-of-the-brainsway-deep-transcranial-magnetic-stimulation-deep-tms-for-treatment-of-alcohol-use-disorder-aud-100609614","NCT07216872","Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)","A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)","Inclusion Criteria:\n\n1. Male or female subjects, 18-86 years old.\n2. Subjects diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (\\> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).\n3. Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening (average \\>=8 HDD\u002Fmonth), based on TLFB).\n4. Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.\n5. Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.\n6. Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.\n\nExclusion Criteria:\n\n1. Subjects diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).\n2. Subjects with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.\n3. Subjects who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin, naltrexone, topiramate and varenicline.\n4. Subjects with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine headaches, etc.).\n5. Subjects experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein subjects with a value of \\>7 will not be permitted to receive TMS on that day to mitigate any potential risk of a seizure. Treatments may be rescheduled and CIWA-AR and alcohol breath tests may be reassessed, although if more than the allowed treatment sessions are missed, the subject will be withdrawn from the study.\n6. Subjects with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).\n7. Individuals with a first-degree relative family history of seizure.\n8. Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.\n9. Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (outside the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work).\n10. Subjects with cardiac pacemakers or active implantable electrodes\u002Fneurostimulators within 30 cm of the treatment coil.\n11. Subjects with a significant neurological disorder or insult including, but not limited to:\n\n    * Any condition likely to be associated with increased intracranial pressure\n    * Space occupying brain lesion\n    * History of cerebrovascular accident\n    * Transient ischemic attack within two years\n    * Cerebral aneurysm\n    * Dementia\n    * Mini Mental State Exam score of less than or equal to 24\n    * Parkinson's disease\n    * Huntington's chorea\n    * Multiple sclerosis\n12. Subjects suffering from significant hearing loss.\n13. Previous treatment with TMS within one year.\n14. Participation in another clinical investigation in which a device or drug has been used within 4 weeks of screening.\n15. If participating in psychotherapy, subject is not in stable treatment for at least 3 months prior to entry into the study or anticipates a change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.\n16. Known or suspected pregnancy or lactation or planning to become pregnant.\n17. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.","86 Years",{"count":5,"type":22},[265],"The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases:\n\n1. Pre-study Screening and Baseline Phase\n2. Acute Treatment Phase and\n3. Maintenance Treatment and Follow up Phase\n\nSubjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration.\n\nEligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks.\n\nThe Maintenance Treatment \\& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit.\n\nAt each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered.\n\nThe study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2-4, based on the Time Line Follow Back (TLFB) reporting. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving.\n\nSafety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.",[28,306,83,304,510,511],"Alcohol Abuse\u002FDependence","Alcohol Addiction",[90,513,514,515,516,517,518,519],"alcoholism","alcohol abuse","alcohol dependence","alcohol addiction","DTMS","rfTMS","Brainsway","2026-06-18",{"date":381,"type":37},{"date":523,"type":37},"2025-11-07",{"date":525,"type":22},"2027-12-01",{"name":519,"class":458},9,{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":45},"100442493","phase-2-donepezil-and-cognitive-training-for-alcohol-use-disorder-aud-100442493","NCT05042102","Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)","The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder","Inclusion criteria:\n\n1. Males and females 18-80 years of age\n2. Fluency in English and a 6th grade or higher reading level\n3. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current alcohol use disorder (subjects should have a primary alcohol use disorder \\[AUD\\] diagnosis, but may have concurrent occasional use of other substances)\n4. Last alcohol use and at least one heavy drinking day within the past 30 days\n5. Willingness to attend follow-up assessments at 13 weeks\n6. Willingness to submit to Urine Toxicology screenings\n\nExclusion criteria:\n\n1. Lifetime diagnosis of a psychotic disorder, not induced by drug use\n2. Current treatment with opioids or benzodiazepines, which may affect new learning\n3. Involvement in a legal case that may lead to incarceration during the study period\n4. Residential plans that would interfere with participation\n5. Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)\n6. An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training\n7. Pre-morbid intelligence quotient (IQ) estimate below 70\n8. Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely\n9. Unwillingness to provide contact information of someone who can help study staff contact the subjects in the event that study staff are unable to maintain contact directly\n10. Allergy to donepezil\n11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician\n12. Imminent suicidal or homicidal risk\n13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential","80 Years",{"count":537,"type":22},160,[25],"The goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.",[28],{"date":406,"type":37},{"date":543,"type":37},"2022-08-08",{"date":545,"type":22},"2026-10-31",{"name":547,"class":548},"VA Connecticut Healthcare System","FED",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":105,"sex":557,"minAge":53,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":565,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":45},"100581669","an-effectiveness-trial-of-the-prep-for-wings-study-100581669","NCT06853314","An Effectiveness Trial of the PrEP for WINGS Study","An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System","PFW","Inclusion Criteria:\n\nIdentify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.\n\nMeet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure\n\nExclusion Criteria:\n\nAbility to speak and understand English is not sufficient to participate in assessments or intervention sessions.\n\nInability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)","FEMALE",{"count":559,"type":22},307,[265],"(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report\u002Fmedical records, recent adherence and longer-term adherence by self-report\u002Fmedical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.\n\n(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race\u002Fethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.",[563,28,564],"HIV Infections","Violence, Gender-Based",[566,567,568,569],"Intimate partner violence","Hazardous alcohol use","HIV infection","PrEP","2026-06-17",{"date":381,"type":37},{"date":573,"type":37},"2026-04-09",{"date":575,"type":22},"2027-06-01",{"name":577,"class":44},"Columbia University",{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":45},"100563637","motivational-interviews-post-hospitalisation-on-maintaining-abstinence-for-1-year-aprs-le-sevrage-en-alcool-100563637","NCT06618755","Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool","IMMANENCE - Intérêt d'un Suivi Sous Forme d'Entretiens Motivationnels spécifiques Post Hospitalisation Sur le Maintien de l'AbstiNENCE Durant l'année Suivant le Sevrage en Alcool","IMMANENCE","Inclusion Criteria:\n\n* With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).\n* Being treated for withdrawal in hospital.\n* With a goal of complete abstinence.\n* With a means of communication (telephone).\n\nExclusion Criteria:\n\n* Lack of understanding (written and spoken) of the French language.\n* Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.\n* Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.\n* Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.\n* Serious decompensated somatic pathology.\n* Non-membership or non-beneficiaries of a national health insurance scheme.\n* Person protected by law, under guardianship or curatorship.\n* Not having signed free and informed consent to participate in the research.\n* Simultaneous participation in another clinical trial.",{"count":587,"type":22},104,[265],"The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :\n\n* Increase the percentage of days of abstinence in the year following withdrawal.\n* Reduce the rate of relapse in the year following withdrawal.\n* An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.\n* A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal.\n\nAll participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.",[28,32,591,592,593],"Alcohol Withdrawal","Motivational Interviews","Relapse",{"date":520,"type":37},{"date":596,"type":37},"2024-12-18",{"date":598,"type":22},"2028-01-13",{"name":600,"class":44},"University Hospital, Montpellier"]