[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,182,0,25,[9,43,61,86,107,137,164,192,218,242,260,285,307,331,352,382,410,436,463,489,511,535,557,582,610],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100609852","phase-3-a-study-of-brenipatide-in-participants-with-moderate-to-severe-alcohol-use-disorder-100609852",false,"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 either of the following:\n\n  * history of advanced liver disease, including advanced liver fibrosis \\[Stage 3\\] or cirrhosis \\[Stage 4\\], based on prior biomarkers, imaging or liver biopsy, OR\n  * history of acute alcohol-associated hepatitis based on prior liver biopsy.\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).","ALL","18 Years","75 Years",{"count":22,"type":23},1100,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","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.",[29],"Alcohol Use Disorder","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2025-10-15",{"date":38,"type":23},"2028-04",{"name":40,"class":41},"Eli Lilly and Company","INDUSTRY",118,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":59,"locationsCount":60},"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 either of the following:\n\n  * history of advanced liver disease, including advanced liver fibrosis \\[Stage 3\\] or cirrhosis \\[Stage 4\\], based on prior biomarkers, imaging or liver biopsy, OR\n  * history of acute or alcohol-associated hepatitis based on prior liver biopsy.\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":22,"type":23},[26],"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.",[29],{"date":33,"type":34},{"date":57,"type":34},"2025-10-16",{"date":38,"type":23},{"name":40,"class":41},116,{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100607669","hepatic-lipid-metabolism-alcohol-use-disorder-100607669","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.","100 Years",{"count":7,"type":23},"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,",[29],[74,75,76],"Alcohol","Liver","Biopsy",{"date":33,"type":34},{"date":79,"type":23},"2026-08-26",{"date":81,"type":23},"2029-11-30",{"name":83,"class":84},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":18,"minAge":93,"maxAge":68,"enrollmentInfo":94,"targetDuration":4,"studyType":24,"phases":96,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":85},"100582230","environment-and-alcohol-a-pilot-study-100582230","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,"21 Years",{"count":95,"type":23},44,[97],"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.",[29],[29],{"date":33,"type":34},{"date":79,"type":23},{"date":104,"type":23},"2028-03-01",{"name":106,"class":84},"National Institute on Drug Abuse (NIDA)",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":85},"100616474","phase-2-methylphenidate-and-response-to-alcohol-cues-100616474","NCT07306078","Methylphenidate and Response to Alcohol Cues","Attentional Ability and Resilience to Alcohol Use Disorder: Neurocognitive Mechanisms: Protocol Two","Inclusion Criteria:\n\n* Adults ages 18-25 years\n* Meets DSM-5 criteria for Alcohol Use Disorder -OR- score on the Alcohol Use Disorders Identification Test (AUDIT) of \\>=8\n* Fluent in English\n* Normal or corrected to normal vision\n\nExclusion Criteria:\n\n* Meets DSM-5 criteria for psychotic disorders, neurological disorders, or substance use disorders other than Alcohol Use Disorder.\n* Participant routinely uses psychoactive drugs or medications except for non-dependent marijuana or nicotine use (due to common use of these substances in individuals with Alcohol Use Disorder).\n* Participant has contraindications for taking methylphenidate.\n* Participant has contraindications for being in an MRI machine\n* Self-reported history of high blood pressure over 140\u002F90 or consistent readings of 140\u002F90 or above upon arrival for a session.\n* History of seizure disorder\n* Liver disease\n* Participant is currently pregnant or trying to become pregnant","25 Years",{"count":116,"type":23},50,[118],"PHASE2","The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on neural and craving responses to alcohol cues through fMRI and behavioral testing. Participants will be involved in one remote and two in-person sessions.",[29],[122,123,124,125,126],"fMRI","methylphenidate","ritalin","attention","alcohol","NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":34},{"date":131,"type":23},"2026-10",{"date":133,"type":23},"2028-08",{"name":135,"class":136},"University of Florida","OTHER",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":68,"enrollmentInfo":144,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":85},"100568688","the-impact-of-heavy-alcohol-use-on-saliva-and-oral-health-100568688","NCT06684483","The Impact of Heavy Alcohol Use on Saliva and Oral Health","Quantifying Associations of Stress and Inflammation-Associated Oral Biomarkers With Oral Health, Oral Health Behaviors, Systemic Biomarkers and Clinical Phenotype in Individuals With Alcohol Use Disorder (AUD)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\nAUD participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Treatment-seeking individuals aged 18 years or older.\n* Able to read and speak English.\n* Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n\nHealthy Control Participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals aged 18 years or older.\n* Able to read and speak English.\n* Self-reported to be in good physical health.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n* AUDIT score of 7 or below.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nPatients with AUD and Healthy Control Participants:\n\n* The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).\n* Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).\n* Part 2 Only: Currently taking or have taken any of the following medications within the last month by self-report; Antibiotics, Corticosteroids, Immunosuppressive or Cytotoxic agents. Topical antibiotics and\u002For corticosteroids on areas other than the oral cavity are not exclusion criteria.\n* Pregnant or breastfeeding\n* Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.\n* Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.",{"count":145,"type":23},72,"Background:\n\nPeople with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD.\n\nObjective:\n\nThis study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD.\n\nEligibility:\n\nPeople aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nThe study is divided into 2 parts: People will participate in either one part or the other.\n\nIn part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth.\n\nIn part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient.\n\nHealthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.",[29,148],"Alcohol Dependence",[150,29,151,152,153,154,155,156],"Oral Health Behaviors","Salivary Bioscience","Stress","Health Behaviors","Salivary Biomarker","Inflammation","Neuropsychological Symptoms",{"date":31,"type":34},{"date":159,"type":34},"2025-01-09",{"date":161,"type":23},"2026-12-31",{"name":163,"class":84},"National Institutes of Health Clinical Center (CC)",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":24,"phases":175,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":85},"100558074","glp-1-ra-on-alcohol-consumption-metabolism-and-liver-parameters-in-patients-with-obesity-and-fatty-liver-disease-100558074","NCT06546384","GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease","Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease","GLP-1 RA","Inclusion Criteria:\n\n* BMI ≥ 35 kg\u002Fm² OR BMI ≥ 28 kg\u002Fm² in the case of weight-related co-morbidities (pre-diabetes or type 2 diabetes mellitus, hypertension, dyslipidemia).\n* Fatty liver disease (steatosis on ultrasound and\u002For CAP value on FS \\> 238 dB\u002Fm)\n* Age 18 - 80 years\n* Alcohol Use Disorder Identification Test-C Score \\>4 (AUDIT-C) Score ≥4 for women and ≥5 for men (as measured from AUDIT-questionnaire distributed in visit 1)\n* Sufficient skills for German or French language (written and spoken)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active illicit substance use\n* AUDIT-score \\\u003C 5 (males)\u002F 4 (females) (as measured from AUDIT-questionnaire distributed in visit 1)\n* Current treatment with drugs against alcohol dependence (disulfiram, acamprosate, naltrexone, baclofen and nalmefene)\n* Any known contraindication to semaglutide\n* Presence or history of a hepatic or extrahepatic malignancy from the previous 6 months","80 Years",{"count":174,"type":23},64,[176],"NA","There is evidence that alcoholic beverage consumption significantly interacts with food energy intake. Furthermore, there is accumulating evidence showing independent, combined, and modifying effects of alcohol and metabolic factors on the onset and progression of chronic liver disease. Preclinical and clinical data have showed that GLP-1 RA can decrease alcohol consumption, particularly in obese patients. Moreover there is evidence that semaglutide can improve the liver sinusoidal milieu in pre-clinical models of cirrhosis.\n\nIn this study, the investigators aim to assess if patients treated with semaglutide and receiving counselling will achieve a significantly higher alcohol abstinence compared to patients only receiving counselling.",[179,180,29],"Adiposity","Fatty Liver",[182,183],"GLP-1","Semaglutide","2026-08-18",{"date":128,"type":34},{"date":187,"type":23},"2026-11-01",{"date":189,"type":23},"2027-04-30",{"name":191,"class":136},"Insel Gruppe AG, University Hospital Bern",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":85},"100467842","aat-for-alcohol-use-disorder-in-veterans-100467842","NCT05372029","AAT for Alcohol Use Disorder in Veterans","Enhancing Treatment Outcomes Among Veterans With Alcohol Use Disorder: Clinical and Neural Markers of Adjunctive Approach-avoidance Training","Inclusion Criteria:\n\n* fluent in English\n* primary diagnosis of AUD with no more than 90 days abstinence from alcohol\n* 4-week stability if taking psychotropic medications\n\nExclusion Criteria:\n\n* lifetime history of psychotic or bipolar disorder\n* neurodegenerative or neurodevelopmental disorders\n* history of moderate or severe traumatic brain injury or other known neurological condition\n* sensory deficits that would preclude completing tasks\n* suicidal or homicidal ideation within the past month necessitating urgent higher level care\n* concurrent individual psychotherapy or other treatment outside of standard DDRP programming\n* conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)","65 Years",{"count":201,"type":23},176,[176],"The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover from alcohol-related functional impairments across social, occupational, and domestic domains. To do so, the investigators will evaluate clinical, cognitive, and neural effects of a computer-delivered Approach Avoidance Training (AAT) treatment - which changes implicit tendencies to approach alcohol-related cues - in conjunction with standard VA care. The project will support RR\\&D's mission to improve Veterans' participation in their lives and community by determining if this innovative alternative technique can improve recovery outcomes for Veterans with AUD and exploring how the intervention works.",[29],[126,206,207,208],"cognitive training","intervention","neuroimaging","2026-08-17",{"date":128,"type":34},{"date":212,"type":34},"2023-02-03",{"date":214,"type":23},"2027-09-30",{"name":216,"class":217},"VA Office of Research and Development","FED",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":24,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":85},"100577229","phase-1-pet-imaging-of-phosphodiesterase-4b-pde4b-in-alcohol-use-disorder-100577229","NCT06795581","PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder","* INCLUSION CRITERIA:\n\n  1. Age 18-70 years\n  2. Willingness to complete the study including MRI tests.\n  3. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n  4. Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n  5. Participants must agree to adhere to the lifestyle considerations.\n  6. Enrolled in protocol 14-AA-0181\n\nEXCLUSION CRITERIA:\n\nClinically significant abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n\n1. Clinically significant abnormalities on EKG.\n2. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n3. Participants with a breath alcohol level (BAL) past 0.08.\n4. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n5. Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission.\n6. HIV infection.\n7. Pregnancy.\n8. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n9. Have an inability to lie flat and\u002For lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n10. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n11. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.","70 Years",{"count":226,"type":23},30,[97],"Background:\n\nPeople with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD.\n\nObjective:\n\nTo find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks.\n\nEligibility:\n\nAdults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181.\n\nDesign:\n\nParticipants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study.\n\nWithin the first week, participants will have a positron emission tomography (PET) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine.\n\nParticipants will have a second PET scan toward the end of their stay in the clinic.\n\nParticipants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....",[29],[231,232,233],"PET Imaging","Alcohol Use Disorder (AUD)","Phosphodiesterase-4B (PDE4B)","2026-08-15",{"date":184,"type":34},{"date":237,"type":34},"2025-03-20",{"date":239,"type":23},"2029-01-31",{"name":241,"class":84},"National Institute of Mental Health (NIMH)",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":224,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":85},"100595083","phase-1-acute-effects-of-alcohol-on-pet-imaging-of-phosphodiesterase-4b-pde4b-100595083","NCT07027839","Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Be enrolled in protocol 14-AA-0181, NIAAA Natural History Protocol.\n2. Age 21 - 70 years.\n3. Willingness to complete the study including MRI tests.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of AUD or SUD. Participants may currently use cannabis recreationally but cannot meet criteria for cannabis use disorder, or present for study visits with positive urine drug screen for THC.\n2. Current non-drinkers (alcohol-naive individuals or no use of alcohol in the past year), or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime.\n3. Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks.\n4. Clinically significant abnormalities on EKG or laboratory tests: CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen), liver function tests (GGT, AST, ALT, bilirubin).\n5. Participants who have taken an antipsychotic or antidepressant medication within two weeks prior to the PET scan #1, with longer washout times of 1 month for antidepressants with longer half-lives such as fluoxetine. In addition, they will be withdrawn if they begin these medications during the two PET scans.\n6. Medication exclusion for alcohol:\n\n6a. Use of prescription or OTC medication known to interact with alcohol 2 weeks prior to screening or screening update visit. These include but may not be limited to: isosorbide; nitroglycerine; benzodiazepines; warfarin; anti-depressants such as amitriptyline, clomipramine and nefazodone; anti-diabetes medications such as glyburide, metformin and tolbutamide; H2-antagonists for heartburn such as famotidine, cimetidine and ranitidine; muscle relaxants; anti-epileptics including phenytoin and phenobarbital; codeine and opioid analgesics including Darvocet, Percocet and hydrocodone.\n\n6b. Regular (more than once a week) or prescribed use of antihistamines, pain medicines, and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib, and naproxen, and unable to refrain from these medications for 48 hours prior to study visits\n\n6c. Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to screening or screening update visit. These include chlorzoxazone, isoniazid, metronidazole, and disulfiram.\n\n7\\) HIV infection.\n\n8\\) Pregnancy or breast feeding.\n\n9\\) Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n\n10\\) Have an inability to lie flat and\u002For lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n\n11\\) Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye",{"count":226,"type":23},[97],"Background:\n\nPhosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and\u002For amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD).\n\nObjective:\n\nTo learn if alcohol increases PDE4B activity in the brain.\n\nEligibility:\n\nHealthy people aged 21 to 70 years who drink socially but do not have AUD. They must be enrolled in protocol 14-AA-0181\"NIAAA Natural History Protocol\".\n\nDesign:\n\nParticipants will have up to 4 clinic visits with up to 3 imaging scans of the brain; these will include 1 or 2 positron emission tomography (PET) scans and 1 magnetic resonance imaging (MRI) scan.\n\nThe first PET scan will be a baseline. Participants will receive a radioactive tracer through a tube inserted into a vein. A second tube will be inserted so that blood can be drawn during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. This visit will take about 6 hours.\n\nFor the next PET scan, participants will receive alcohol (ethanol) through a tube in a vein until they have a blood alcohol concentration that is equal to the legal driving limit. This is the same as 4 or 5 drinks for most people. After the scan, participants must remain at the clinic for a few hours until their blood alcohol drops. This visit will take 14 to 16 hours.\n\nThe MRI scan of the brain will take up to 2 hours in a separate clinic visit.",[29],[231,232,233],"2026-08-14",{"date":209,"type":34},{"date":256,"type":34},"2025-12-11",{"date":258,"type":23},"2029-02-22",{"name":241,"class":84},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":281,"leadSponsor":283,"locationsCount":85},"100615706","phase-2-psilocybin-assisted-psychotherapy-for-the-treatment-of-severe-alcohol-use-disorder-100615706","NCT07296094","Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder","Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial","To be eligible, individuals must be:\n\n* English speaking adults between ages 18 and 65\n* Diagnosis of DSM5 AUD, severe\n* Completion of inpatient withdrawal management (i.e. \"detox\") for AUD within 90 days of enrollment\n* Amenable to attending all psychotherapy and study visits at BWH CCI\n* Able to identify an individual who can act as points of contact during the trial\n* Have a friend or family member who can bring the participant home after the psilocybin sessions and stay overnight\n\nIndividuals with any of the following will be excluded:\n\n* • Any personal history of a psychotic disorder (schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, substance-induced psychotic disorder or major depression with psychotic features) or any bipolar-spectrum disorder\n* Participants with a family history of first-degree relatives with psychotic disorder or bipolar-spectrum disorder\n* Participants who have a significant suicide risk as defined by current suicidal ideation (Columbia-Suicide Severity Rating Scale (C-SSRS) score 2 to 5) and\u002For recent (within the past 6 months) active suicidal ideation (C-SSRS score 4 or 5)\n* Participants who have a history of significant or serious adverse reaction to classic psychedelics\n* Homicidality within the last six months\n* History of DSM5 hallucinogen use disorder\n* Positive breath alcohol level at screening\n* Need for inpatient withdrawal management for alcohol at the time of screening\n* Current DSM5 opioid, cocaine, stimulant or sedative\u002Fhypnotic use disorder\n* Systolic blood pressure persistently above 165mmHg during screening\n* History of hypersensitivity to psilocybin\n* Use of psilocybin or other psychedelics with 5-HT2B activity in the prior 12 months\n* Significant EKG abnormalities including QTc prolongation defined as \\>450 ms for men and women, or a diagnosis or family history of Long QT syndrome.\n* History of any cardiac valvulopathy that raises the risk for participation as determined by the cardiology consultant\n* History of intracranial mass or bleed, seizure disorder other than alcohol withdrawal seizures, liver cirrhosis, renal failure, obstructive lung disease requiring supplemental oxygen, hyperthyroidism, narrow-angle glaucoma, uncontrolled cardiac arrythmias, heart failure\n* History of head trauma, stroke, or myocardial infarction in one year prior to enrollment.\n* Expected to require surgical treatment at any point during the trial\n* Liver dysfunction with LFTs \\> 3x upper normal limit at screening and Total bilirubin \\> 2.5x the upper normal limit\n* MRI contraindications (other ferromagnetic implants, body weight greater than 550 lbs., etc.)\n* Pregnant or breastfeeding\n* High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators such as evidence of a personality disorder\n* Currently taking medications with serotonergic activity (other than SSRIs\u002FSNRIs); inhibitors of UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase; antipsychotics (e.g., first and second generation); mood stabilizers (e.g., lithium, valproic acid); or significant inhibitors of UGT enzymes that metabolize psilocin\n* Selective serotonergic reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors are allowed if participants have been on stable doses of the medication(s) for at least 90 days prior to enrollment.\n* Currently receiving insulin for blood sugar management.",{"count":268,"type":23},36,[118],"This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).",[29],[273,274,275,276],"alcohol use disorder","psilocybin","inpatient withdrawal management","psychedelic","2026-08-11",{"date":279,"type":34},"2026-08-13",{"date":234,"type":23},{"date":282,"type":23},"2030-02",{"name":284,"class":136},"Brigham and Women's Hospital",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":172,"enrollmentInfo":293,"targetDuration":4,"studyType":24,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100609728","phase-3-cessation-or-reduction-of-alcohol-consumption-in-veterans-a-randomized-double-blind-placebo-controlled-phase-3-trial-to-evaluate-the-efficacy-and-safety-of-a-glp-1-receptor-agonist-semaglutide-in-us-veterans-with-alcohol-use-disorder-100609728","NCT07218354","Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)","CSP #2041 - Cessation or Reduction of Alcohol Consumption in VEterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder (CRAVE)","CRAVE","Inclusion Criteria:\n\n* Veteran\n* WHO risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)\n* Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam (MINI)\n* Able and willing to provide informed consent\n* Has a desire to reduce their alcohol consumption\n\nExclusion Criteria:\n\n* Medical History (medical history form)\n\n  * Type 1 diabetes\n  * History of acute or chronic pancreatitis\n  * History of diabetic ketoacidosis\n  * History of proliferative diabetic retinopathy\n  * History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC)\n  * History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of \\>12 kPa, FIB-4 ≥2.67, ELF ≥9.8, MRE ≥3.63 kPa\n  * History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy\n  * History of esophageal varices on endoscopy or imaging\n  * History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging\n  * History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \\> 1.5 times the upper limit of normal)\n  * History of primary biliary cholangitis\n  * History of primary sclerosing cholangitis\n  * Current drug-induced liver disease\n  * History of alpha1 antitrypsin deficiency related liver disease\n  * History of autoimmune liver disease\n  * History of hemochromatosis\n  * History of Wilson's disease\n  * Presence of gastroparesis\n  * History of acute gallbladder disease in the prior 6 months\n  * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)\n  * Unstable body weight defined as \\>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization\n  * Recent major cardiovascular event in the 90 days prior to randomization (myocardial infarction, stroke, New York Heart Association class IV heart failure, transient ischemic attack (TIA), or unstable angina\n  * Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue\n* Concurrent Treatments (medical history form):\n\n  * Current (within the past 30 days) use of pharmacotherapy for AUD (including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate)\n  * Current (within the past 30 days) use of the following medications with glucose-lowering properties: GLP-1 analogues; sulfonylurea; insulin and insulin products; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose cotransporter-2 (SGLT-2) inhibitors, meglitinides, thiazolidinediones or other medications that may interact with semaglutide\n  * Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing)\n* Psychiatric diagnosis (MINI)\n\n  * Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia)\n  * Current DSM-5 diagnosis of a SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders)\n* Other assessments (local site)\n\n  * At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \\>8)\n  * BMI \\\u003C21 kg\u002Fm2\n  * Acute high risk of suicide requiring hospitalization at the time of screening or randomization\n  * Medical, psychiatric, behavioral, or logistical conditions which, in the judgment of the Local Site Investigator (LSI) or Co-Investigator (Co-I), make it unlikely the participant can participate in or complete the 24-week active phase of the study\n  * Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH\n  * Currently enrolled in another therapeutic or investigational clinical trial without a preexisting dual enrollment agreement\n  * Participant is incarcerated\n* Laboratory\n\n  * Hemoglobin A1c (HbA1c)\\>10\n  * Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n  * Albumin \\\u003C 3.5 g\u002Fdl\n  * Aspartate aminotransferase (AST) \\>3 the Upper Limit of Normal (ULN)\n  * Alanine aminotransferase (ALT) \\>3 the ULN\n  * Lipase \\> 2 times the upper limit of normal\n  * Alkaline phosphatase \\> 1.5 times the ULN\n  * Total bilirubin \\> 1.5 times the ULN except with documented Gilbert's syndrome\n  * International Normalized Ratio (INR) \\> 1.3 unless due to anticoagulation therapy\n  * Platelet count \\\u003C150,000\u002F L unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension\n  * Hepatitis B surface antigen positive\n  * Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing\n  * Anti-HIV antibody positive test with uncontrolled or unstable treatment\n  * Positive urine drug screen for substances other than cannabis and prescribed medications\n  * Positive urine pregnancy test at screening in those considered of childbearing potential",{"count":294,"type":23},622,[26],"This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.",[29],[29,183,74,182],{"date":300,"type":34},"2026-08-12",{"date":302,"type":34},"2026-07-28",{"date":304,"type":23},"2030-03-30",{"name":216,"class":217},19,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":68,"enrollmentInfo":314,"targetDuration":4,"studyType":24,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":85},"100596542","phase-2-tirzepatide-in-metald-100596542","NCT07046819","Tirzepatide in MetALD","A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 21 or older\n2. Ability to provide written informed consent\n3. Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)\n4. Males: Agree to abstain or use accepted form of contraception, such as condoms.\n5. Diagnosis of AUD as confirmed by MINI\n6. Current alcohol use as assessed via the TLFB (\\>14 standard drinks per week for males and \\>7 standard drinks per week for females on average for the last 8 weeks)\n7. Liver steatosis as determined by Fibroscan (CAP score \\>240) at screening\n8. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n9. metALD as defined by at least one out of 5 criteria at screening:\n\n   1. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n   2. Fasting serum glucose \\>= 5.6mmol\u002FL \\[100mg\u002FdL\\] or HbA1c \\>=5.7%\n   3. Blood pressure \\>=130\u002F85 or specific antihypertensive drug treatment\n   4. Plasma triglycerides \\>=1.70mmol\u002FL \\[150mg\u002FdL\\] or lipid lowering treatment\n   5. Plasma HDL-cholesterol less than 1.0mmol\u002FL \\[40mg\u002FdL\\] or lipid lowering treatment\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Treatment seeking for alcohol use disorder\n2. History of a serious hypersensitivity reaction to GLP-1RA\u002FGIPRA\n3. Current\u002Fpast use of GLP-1RA\u002FGIPRA within the last 3 months\n4. Clinically significant and\u002For unstable cardiovascular disease over the past 12 months\n5. History of diabetes mellitus or blood hemoglobin A1c (HbA1c) \\>= 6.5 % at screening\n6. Any underlying clinically significant and\u002For unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices\n7. Subjects with platelets count of less than 110,000\u002F mm\\^3\n8. Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening\n9. Bilirubin 2x UNL or Creatinine \\> 2 mg\u002FdL at screening\n10. Patients with coagulopathy defined as INR \\>1.5, prothrombin time prolonged by \\> 3s, and\u002For platelets \\\u003C75,000 \u002F mm\\^3 at screening\n11. Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and\u002For positive Hepatitis C antibody (HCV) at screening\n12. Chronic renal failure as estimated by glomerular filtration rate (GFR) \\\u003C 60mL\u002Fmin\u002F1.73 m\\^2 at screening\n13. History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n14. History of previous bariatric surgery or transplant surgery\n15. Patients with significant hematologic abnormalities, as defined by hemoglobin \\\u003C 8g\u002FdL and\u002For white blood count \\\u003C1500 cells\u002FmicroL\n16. Current or prior history of any clinically significant disease, including, seizure disorder, epilepsy, alcohol related seizures within 12 months of screening, uncontrolled endocrine disease, hemorrhagic stroke, cancer within the past 5 years or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study\n17. Use of any medications that interfere with tirzepatide\n18. Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA\u002FGIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors\n19. Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids\n20. Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures\n21. Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year\n22. History of serious mental illnesses including psychotic disorders, bipolar disorders, severe anxiety, mood, or trauma-related disorders and other psychiatric conditions which in the opinion of the investigators would impede the patient's participation or compliance in the study\n23. History of liver decompensation events such as hepatic encephalopathy or ascites\n24. History of severe gastroparesis\n25. History of pancreatitis in the last 5 years or if subject has chronic pancreatitis\n\nFor optional MRI: a) Presence of ferromagnetic objects in the body that may be adversely affected by or contraindicated for MRI, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report b) Use of MRI- incompatible intrauterine device (IUD).\n\nIndividuals who are pregnant or breastfeeding, or with severe hepatic or renal liver impairment will be excluded from this study because there is no clinical data on the safety of tirzepatide in these populations, including the impact on the fetus or infant. To assess pregnancy status, participants who can become pregnant will be required to take a urine pregnancy test and to test negative before administering study drug.",{"count":315,"type":23},120,[118],"Background:\n\nPeople with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake.\n\nObjective:\n\nTo test Tirzepatide in people with AUD and MetALD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD and MetALD.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver.\n\nThese tests will be repeated in a baseline visit. This visit will take up to 6 hours.\n\nTirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours.\n\nAll tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.",[319,29],"Metabolic Alcohol-associated Liver Disease",[321,322,74,323],"BMI","Weight","Metabolism",{"date":300,"type":34},{"date":326,"type":34},"2026-06-11",{"date":328,"type":23},"2027-07-30",{"name":330,"class":84},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":199,"enrollmentInfo":338,"targetDuration":4,"studyType":24,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":85},"100542916","phase-2-neurobehavioral-mechanisms-of-psilocybin-assisted-treatment-for-aud-100542916","NCT06349083","Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD","Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder","Inclusion Criteria:\n\n1. Are able to provide voluntary informed consent\n2. Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening period.\n3. Are able to read, speak, and understand English, as documented during the informed consent process.\n\n   a. Non-English speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments.\n4. Are 18 to 65 years old, inclusive, at Screening visit.\n5. Have DSM-5 diagnosis of moderate or severe AUD (using MINI)\n6. Eligible participants must either (a) not currently receiving treatment for alcohol use disorder (AUD), or (b) have been in continuous treatment for AUD for at least 3 months and plan to continue. (Any medications used to treat AUD would need to be discontinued no less than 5 half lives or 14 days (whichever is greater) prior to the IP administration session. Patients who who are completing detoxification from alcohol and do not have plans for follow-up treatment would be eligible to participate in the study after completion of the detoxification program).\n7. Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments.\n8. Have least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to admission to the screening visit.\n9. Agree to refrain from alcohol use as well as any non-prescribed psychotropic substance or illicit drug use for at least 24 hours prior to investigational product (IP) administration and before each fMRI assessment visit, with the exceptions of nicotine and caffeine. Regarding nicotine, they must agree not to use nicotine for at least 1 hour before and 6 hours following IP administration, and for at least 1 hour before fMRI scans. Regarding caffeine, they must agree to consume approximately their usual amount of caffeine on the morning of Day 0 (prior to IP administration).\n10. Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.\n11. Are able to swallow capsules.\n12. If able to become pregnant, have a negative serum pregnancy test at screening.\n13. If able to become pregnant or produce viable sperm (male or female), are willing to use approved contraception for duration of the trial\n14. Able to provide at least 2 locators.\n15. Participants must be able to commit to being sober at the time all treatment sessions and the two fMRI sessions, and to stay sober from the time of the drug administration until the second fMRI session.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests:\n\n   1. Seizure disorder\n   2. Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN); 2) ALT or AST \\> 3 × ULN with concomitant total bilirubin \\> 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and\u002For eosinophilia.\n   3. Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack.\n   4. Uncontrolled hypertension with systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg. (Note: participants who otherwise meet all eligibility criteria during the screening visit will have 3 opportunities to produce 1 blood pressure reading ≤ 140\u002F90 mmHg (each reading will be collected at least 15 minutes apart). If blood pressure at Screening is consistently elevated (\\> 140\u002F90 mmHg across all 3 attempts), participants may be referred to their medical provider for management of hypertension. Participants may continue study participation if they are able to provide documentation of adequate control (BP \\> 140\u002F90 mmHg) prior to the IP administration session.)\n   5. Resting heart rate \\> 100 bpm (Note: participants will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.).\n   6. Serious ECG abnormalities present on the ECG obtained at the screening visit (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.450 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia.\n   7. Hyperthyroidism\n   8. Insulin-dependent diabetes\n   9. Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated on Day 0. Those not meeting the criterion will not be randomized but may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator.)\n3. Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History at the Screening Visit: (Note: psychiatric history will be re-evaluated on Day 0, but the MINI will not be re-administered on Day 0)\n\n   1. Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a co-occurring medical condition).\n   2. Current alcohol withdrawal (CIWA-Ar score \\>7)\n   3. History of mania\n4. Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS) (past week severity score \\>3) at the Screening visit, confirmed by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0 prior to randomization. Participants will be withdrawn if actively suicidal, and appropriate follow-up will be arranged.\n5. Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0 prior to randomization. Participants will be withdrawn if actively suicidal, and appropriate follow-up will be arranged.)\n6. Have a family history (first degree relatives) of schizophrenia, schizoaffective disorder, or bipolar disorder type 1.\n7. Have a history of hallucinogen use disorder.\n8. Have a history of hallucinogen persisting perceptual disorder (HPPD).\n9. Have any use of classic psychedelics in the past 1 year.\n10. Have \\> 25 lifetime uses of classic psychedelics.\n11. Incarcerated or have pending legal action that could prevent participation in study activities.\n12. Are court-mandated to complete treatment or are a prisoner.\n13. Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements. (A detailed list of exclusionary medications is found in Section 6.5 of the protocol). Current SSRI use is allowed only if the dose has been stable for at least one month at the time of Screening visit. Prohibited medications and supplements must have been stopped for at least 5 elimination half-lives or 14 days, whichever is longer, prior to Day 0 (Note: Psychiatric medications will not be discontinued or changed in order to allow study participation unless such change does not cause any increase in risk to the study participant, in the judgement of the study physician and the prescribing provider. For example, a change in a medication for sleep might be appropriate if a non-exclusionary alternative is available. Any such study-related changes in medication will be documented in a progress note which will include explanation for why the change does not increase overall clinical risk and documentation of the prescribers concurrence with the treatment plan.)\n\n    a. Note that any medication prescribed to the participant for AUD is exclusionary, including FDA-approved medications as well those prescribed off-label, such as topiramate, ondansetron, gabapentin, and varenicline.\n14. Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study.\n15. Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary during or immediately after the IP Administration Session, using the adjunctive medications used in this study to treat these symptoms (i.e., unable to take captopril and unable to take clonidine; unable to take diazepam; or unable to take olanzapine).\n16. Have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of psilocybin or fMRI scanning, based on the judgement of the Investigator.\n17. Inability to safely complete fMRI sessions (MRI screening form), including presence of metallic implants or devices that contraindicate MRI or claustrophobia.\n18. Any history of severe traumatic brain injury (assessed using OSU TBI-ID modified). (Note: If current (past 12 months) mild\u002Fmoderate TBI and CSI score \\>\u002F=12 (for either lifetime month or current month), the PI will determine eligibility.)",{"count":339,"type":23},200,[118],"This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.",[29],[274,344],"AUD",{"date":300,"type":34},{"date":347,"type":23},"2026-09-01",{"date":349,"type":23},"2030-05",{"name":351,"class":136},"NYU Langone Health",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100560999","drinking-acetate-and-stress-100560999","NCT06584448","Drinking, Acetate, and Stress","Role of Acetate in Heavy Drinking","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Medically stable male or female, aged 18-55.\n* Able to read, write and complete a multitude of self-assessments in English\n* Meets DSM-5 criteria for current Alcohol Use Disorder (AUD)\n* Participants who have Alcohol Use Disorder and are actively drinking must be willing to receive (at no cost) inpatient treatment for AUD for a period of up to 30 days. Participants who have been treated for an Alcohol Use Disorder and are now sober three months or longer will NOT be required to go inpatient.\n\nExclusion Criteria:\n\n* Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures (for LTS subjects only- seizures directly related to alcohol detoxification are not an exclusion) , delirium or hallucinations, or other unstable medical conditions, including HIV.\n* Current DSM-5 substance use disorder (other than AUD or tobacco use disorder)\n* Any metallic objects implanted in their body which would make imaging unsafe (pacemaker, etc)\n* Claustrophobia, or other inability to participate in an MRI\n* A positive test result at intake appointment and subsequent appointments on urine drug screens conducted for illicit drugs. (Note: participants will not be paid for study visits if they test positive for an illicit drug and will be immediately excluded from study).\n* Women who are pregnant or nursing. Women who have an IUD that would make imaging unsafe.\n* Recent taking of medications that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).\n* Subjects likely to exhibit clinically significant alcohol withdrawal during the study.","60 Years",{"count":116,"type":23},[176],"The purpose of this study is to learn how drinking alcohol affects how people experience stress and how that is affected by the body's chemistry. Specifically, the investigators will be studying relationships of drinking and a stress hormone called cortisol. The investigators believe that results will lead us to find more effective ways to help people stop or reduce drinking when participants are drinking at harmful levels.",[29,364,365,366],"Alcohol Use, Unspecified","Heavy Drinker","Alcohol Use Disorder, Moderate, in Sustained Remission",[368,152,369,370,371,372],"Brain","Imaging","Detoxification","Recovery","Sobriety","2026-08-10",{"date":300,"type":34},{"date":376,"type":34},"2024-11-06",{"date":378,"type":23},"2030-01",{"name":380,"class":136},"Yale University",2,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":390,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":85},"100591861","self-concept-and-autobiographical-memory-in-alcohol-use-disorder-100591861","NCT06985927","Self-Concept and Autobiographical Memory in Alcohol Use Disorder","Self-Concept and Autobiographical Memory in the Care of Patients With Alcohol Use Disorder","CoSMA","Inclusion Criteria:\n\n* Patients over 24 years old, men or women\n* Having a diagnosis of alcohol use disorder according to DSM-5 criteria\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion Criteria:\n\n* A diagnosis of current non-stabilized psychiatric disorders according to DSM-5 criteria\n* The presence of another substance use disorder, except for tobacco dependence\n* The presence of any intellectual disability, of pervasive developmental disorders\n* The presence of any neurological disorder or any other disorder affecting the central nervous system including neurological complications of alcoholism\n* A sensorial impairment uncorrected (visual and\u002For hearing)","24 Years",{"count":392,"type":23},100,[176],"This study has two objectives. First, to evaluate the effectiveness of psychotherapy sessions based on self-concept and autobiographical memory in patients suffering from alcohol use disorders (AUD). Second, investigate the relationship between drinking identity and AUD. These objectives will be investigated according to a longitudinal design.\n\nIn this study, the drinking identity is evaluated on its implicit dimension and on its explicit dimension. Levels of alcohol use and dependence are assessed by the amount and frequency of drinking, the duration of abstinence, and the intensity of AUD symptoms. These assessments consist three visits: on the day of inclusion, then at three months and six months after the first visit. The psychotherapy sessions consist of four individual sessions. They are inspired by the Social Identity Mapping in Addiction Recovery (SIM-AR) by Beckwith et al. (2019), combined with autobiographical reasoning exercises.\n\nPatients with an AUD, participants in the study, are recruited from the addiction department of the Etablissement Public de Santé Mentale de la Marne. To investigate the effects of individual psychotherapy sessions, two groups of patients are constituted randomly. The first group will have four psychotherapy sessions between the first visit and the second vist. The second group will not follow psychotherapy sessions but will benefit from the usual addiction treatments.\n\nThe first hypothesis is that patients who have completed the psychotherapy sessions will have lower alcohol consumption (frequency, quantities, peaks) and symptoms of AUD (cravings, drinking refusal self-efficacy and feeling of recovery) than those who have not benefited from the program.\n\nThe second hypothesis is that implicit and explicit levels of drinking identity will predict alcohol consumption (frequencies, quantities, peaks) and symptoms of dependence (cravings, drinking refusal self-efficacy and feeling of recovery) for all participants.",[29],[397,398,399,400],"Alcohol Use Disorders","Self-Concept","Autobiographical Memory","Psychotherapeutic Care","2026-08-04",{"date":403,"type":34},"2026-08-05",{"date":405,"type":34},"2025-05-28",{"date":407,"type":23},"2027-12",{"name":409,"class":136},"CHU de Reims",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":92,"sex":18,"minAge":93,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":24,"phases":419,"briefSummary":420,"conditions":421,"keywords":426,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":85},"100640797","effects-of-ketogenic-diet-on-alcohol-intoxication-100640797","NCT07602270","Effects of Ketogenic Diet on Alcohol Intoxication","Inclusion Criteria:\n\n1. Age 21 years to 50 years old.\n2. Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.\n\nExclusion Criteria:\n\n1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.\n2. Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.\n3. Currently taking medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified)\n4. Positive urine drug screen, positive for all substances but marijuana at screening or study visits (may be repeated once and if the result is negative on repeat, it is not exclusionary).\n5. A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement, administration of ketogenic diet, or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).\n6. Currently suffering from or has a history of stroke and\u002For stroke related spasticity.\n7. Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture, inter-cranial bleeding or abnormal MRI (self-report, medical history).\n8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).\n9. Females who are pregnant or breast-feeding\n10. Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent subjects from lying comfortably flat on his\u002F her back for up to 2 hrs.","50 Years",{"count":418,"type":23},20,[176],"The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \\~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +\u002F- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.",[422,423,29,424,425],"Ketogenic Diet","Alcohol Drinking","Magnetic Resonance Imaging","Alcohol Intoxication",[422,427],"Alcohol tolerance test","2026-08-03",{"date":401,"type":34},{"date":431,"type":34},"2026-05-14",{"date":433,"type":23},"2030-05-01",{"name":435,"class":136},"University of Pennsylvania",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":443,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":85},"100606702","mobile-platform-for-optimizing-wellness-and-engagement-in-recovery-100606702","NCT07178990","Mobile Platform for Optimizing Wellness and Engagement in Recovery","MPOWER","Inclusion Criteria:\n\n* Participants must be enrolled in the Michigan Medicaid program\n* Opioid agonist treatment (OAT): Participants must have initiated OAT with buprenorphine or methadone\n* Participants must have an OAT prescription and Alcohol use disorder (AUD) based on self-report measure during screening\n* Participants must have regular access to a working smartphone and internet connection.\n* Participants must have a reliable mailing address to receive study supplies (e.g., salivary drug tests).\n\nExclusion Criteria:\n\n* Primary Medicare Coverage: Individuals that are dual-eligible for Medicaid and Medicare and aged 65 or older, due to limited availability of Medicaid claims data for this group\n* Individuals that cannot voluntarily provide informed consent themselves for any reason, including legal incompetency\n* Individuals with substantial cognitive impairment that would interfere with study participation\n* Individuals unable to read or understand English\n* Individuals experiencing active suicidality or psychosis.\n* Individuals with a planned admission to residential treatment or incarceration during the study period.","19 Years","63 Years",{"count":116,"type":23},[176],"This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM) treatment among Medicaid beneficiaries. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.",[449,29,450],"Opioid Agonist Treatment","Opioid Use Disorder",[452,453,454],"Research surveys","App based program","Smartphone",{"date":456,"type":34},"2026-08-06",{"date":458,"type":34},"2025-12-08",{"date":460,"type":23},"2027-07-31",{"name":462,"class":136},"University of Michigan",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":477,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":485,"leadSponsor":487,"locationsCount":381},"100650393","snoezelen-therapy-in-adults-with-alcohol-dependence-and-adults-with-schizophrenia-100650393","NCT07748078","Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia","Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia","1. Adults suffering from schizophrenia requiring permanent institutional care, N=40\n\n   Inclusion criteria:\n   * women and men aged ≥ 18 years,\n   * consent of the patient or legal guardian to participate in the study,\n   * schizophrenia clinically confirmed for at least 5 years, with predominance of negative symptoms,\n   * stable drug therapy (treatment unchanged for at least 3 months)\n   * ability to understand and follow the therapist's instructions,\n   * functional ability of everyday life on the Barthel scale below 40 points,\n\n   Exclusion criteria:\n   * lack of consent to participate in the study;\n   * pregnancy;\n   * general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);\n   * unstable or untreated epilepsy, based on EEG;\n   * exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);\n   * active cancer disease;\n   * diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;\n   * diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.\n2. Adults (men) suffering from schizophrenia, N=40\n\n   Inclusion criteria:\n   * men aged ≥ 18 years,\n   * consent of the patient or legal guardian to participate in the study,\n   * clinically confirmed schizophrenia with predominance of negative symptoms,\n   * stable drug therapy (treatment unchanged for at least 1 month),\n   * ability to understand and follow the therapist's instructions,\n   * functional ability of everyday life on the Barthel scale above 40 points,\n\n   Exclusion criteria:\n   * lack of consent to participate in the study;\n   * general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);\n   * unstable or untreated epilepsy, based on EEG;\n   * exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);\n   * active cancer disease;\n   * diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli; diseases and illnesses of the musculoskeletal system disturbing body balance and limb mobility.\n3. Adults (women) addicted to alcohol, N= 60\n\nInclusion criteria:\n\n* female gender;\n* age ≥ 18 years;\n* consent of the patient or legal guardian to participate in the study;\n* alcohol dependence syndrome (F10.2 according to ICD-10);\n* history of depressive and anxiety symptoms;\n* ability to understand and follow the therapist's instructions;\n* functional ability of everyday life on the Barthel scale above 40 points.\n\nExclusion criteria:\n\n* lack of consent to participate in the study;\n* pregnancy;\n* psychoactive substances other than alcohol;\n* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);\n* mental illnesses other than depression and anxiety disorders;\n* psychotic diseases (F20- schizophrenia and other schizophrenic disorders);\n* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);\n* unstable or untreated epilepsy, based on EEG;\n* active cancer disease;\n* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;\n* severe cognitive impairment;\n* diagnosis of autism and ADHD;\n* PTSD;\n* intellectual disability (diagnosis F70 - F79);\n* diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.",{"count":471,"type":23},140,[176],"The purpose of the study: obtaining knowledge about the impact of Snoezelen® therapy on the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol.\n\nThe main questions it aims to answer are:\n\nDoes Snoezelen therapy improve the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol?\n\nThe participant will participate in Snoezelen® therapy for 6 or 12 weeks, 2 times a week (30 minutes each session).",[475,29,476],"SCHIZOPHRENIA 1 (Disorder)","Alcohol Dependence (Primary Condition)",[478,479,480,481],"Snoezelen® therapy","Snoezelen","alcohol dependence","schizophrenia","2026-07-31",{"date":403,"type":34},{"date":347,"type":23},{"date":486,"type":23},"2027-12-30",{"name":488,"class":136},"The Jerzy Kukuczka Academy of Physical Education in Katowice",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":85},"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":418,"type":23},[97],"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.",[29],[502,503,29,504,505],"Alcohol Consumption","Alcohol Problems","SPIRONOLACTONE","Mineralocorticoid Receptor",{"date":428,"type":34},{"date":508,"type":34},"2023-07-13",{"date":189,"type":23},{"name":106,"class":84},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":172,"enrollmentInfo":517,"targetDuration":4,"studyType":24,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":531,"leadSponsor":533,"locationsCount":381},"100576826","phase-3-optimizing-treatment-of-co-occurring-smoking-and-unhealthy-alcohol-use-among-pwh-in-nairobi-kenya-100576826","NCT06790342","Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya","Inclusion Criteria:\n\n1. Confirmed chart diagnosis of HIV\n2. At least 18 years or age\n3. Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.\n4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)\n5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse\u002Fheavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or \\>7 drinks\u002Fweek over the past 30 days\n6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)\n7. Willingness to accept behavioral and\u002For pharmacologic tobacco and alcohol treatment\n8. Willingness and ability to provide informed consent to participate.\n\nExclusion Criteria:\n\n1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment\n2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)\n3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations\n4. Pregnant, nursing, or becoming pregnant during the study\n5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician\n6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale\n7. Unstable psychiatric illness\n8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period\n9. Expected survival of less than 6 months.",{"count":518,"type":23},300,[26],"People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.",[522,523,29],"HIV","Tobacco Use",[522,525,526],"Tobacco Cessation","Alcohol Reduction","2026-07-29",{"date":529,"type":34},"2026-07-30",{"date":482,"type":23},{"date":532,"type":23},"2029-06-01",{"name":534,"class":136},"University of Chicago",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":556},"100539575","implementation-of-mobile-based-programs-for-alcohol-cessation-in-treatment-of-alcohol-associated-liver-disease-100539575","NCT06305624","Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease","Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1","IMPACT-ALD","Inclusion Criteria (Aim 1):\n\n* Diagnosis of ALD (any stage)\n* Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.\n* Alcohol use within the last 6 months\n* Receiving care at UW or Henry Ford Health + MSU\n\n  * Either the general hepatology clinic or the multidisciplinary ALD clinic\n* Able to read and write proficiently in English\n* Willing and able to use a smartphone app\n\nExclusion Criteria:\n\n* Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation\n* In hospice care\n* Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and\u002For unable to maintain cognitive alertness during screening--as determined by study staff.)",{"count":544,"type":23},298,[176],"This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.",[29,548],"Alcohol-related Liver Disease",{"date":482,"type":34},{"date":551,"type":34},"2024-06-01",{"date":553,"type":23},"2027-10-31",{"name":555,"class":136},"University of Wisconsin, Madison",3,{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":566,"conditions":567,"keywords":571,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":85},"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":565,"type":23},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.",[29,568,569,570],"Alcohol-associated Liver Disease","Alcoholic Cirrhosis","Healthy",[572],"Pomeragranate, AUD, ALD","2026-07-22",{"date":575,"type":34},"2026-07-24",{"date":577,"type":23},"2027-01-01",{"date":579,"type":23},"2032-12-31",{"name":581,"class":136},"University of Louisville",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":496,"enrollmentInfo":589,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":85},"100558563","screening-evaluation-and-assessment-sea-protocol-at-the-nida-irp-100558563","NCT06552741","Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP","Screening, Evaluation, and Assessment (SEA) Protocol at the NIDA IRP","* INCLUSION CRITERIA:\n\nThis protocol is seeking individuals with current or past SUDs and\u002For AUD, as well as those who have never had an SUD or AUD. These individuals also may or may not be in treatment for their AUD\u002FSUDs.\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n* Age 18-99 years old.\n* Proficient ability to read, write, and understand English.\n* Stated willingness to comply with all screening procedures and availability for the duration of the screening period\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nIndividuals who lack capacity to consent to research participation to this protocol as determined by the Evaluation to Sign Consent (ESC).",{"count":590,"type":23},10000,"Background:\n\nPeople who will participate in research studies need to undergo proper screening, evaluation, and assessment (SEA). SEA helps keep those who participate in studies safe. It also helps ensure accurate study results. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) wants to screen people with alcohol and\u002For substance use disorders (ASUD) as well as people without ASUD for ongoing studies at NIDA in Baltimore, MD\n\nObjective:\n\nTo screen people with or without ASUD for ongoing studies at NIDA. The ultimate goals are to learn why some people (1) use drugs; (2) stop using drugs; (3) use drugs but do not get addicted; and (4) never use drugs snd to develop ASUD treatments.\n\nEligibility:\n\nPeople aged 18 years and older. They may (1) currently use nicotine, alcohol, opioids, cocaine, or other drugs; (2) no longer use them; or (3) have never used them.\n\nDesign:\n\nParticipants will have 1 screening visit that could last up to 8 hours. The visit may be split over more than 1 day. The duration of the screening may vary for each individual based on which studies they are interested in and screened for. The tests they undergo may vary and may include the following:\n\n* Physical exam.\n* Blood, saliva, and urine tests.\n* Breath samples that test for alcohol and carbon monoxide.\n* Test of heart function.\n* Smell test that measures sense of smell.\n* Tests of memory, attention, and thinking.\n* Mental health evaluation.\n* Mock magnetic resonance imaging (MRI) scan.\n* Questionnaires about alcohol and other drug use, mental health, medical history, and life in general.",[593,29],"Substance Use Disorder",[74,595,596,597,598,599,600,601,602],"Drug","Smoking","Substance","Opioid","Nicotine","Cocaine","CONTROL","Vaping","2026-07-21",{"date":573,"type":34},{"date":606,"type":34},"2024-09-04",{"date":608,"type":23},"2047-01-01",{"name":106,"class":84},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":199,"enrollmentInfo":616,"targetDuration":4,"studyType":24,"phases":618,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":635,"locationsCount":85},"100536807","phase-4-temporally-resolved-electrophysiology-of-acamprosate-treatment-of-alcohol-use-disorder-100536807","NCT06269627","Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 21-65. In younger participants, the central nervous system has not sufficiently developed, whereas in older participants, degenerative changes may confound the studied measures. Moreover, the minimum legal drinking age is 21 years.\n2. Enrolled in NIAAA natural history protocol 14-AA-0181.\n3. Admitted to alcohol treatment program of NIAAA with moderate to severe alcohol use disorder by a clinician at the time of admission.\n4. Determination by the attending physician or licensed practitioner caring for the patient that the patient's current clinical status is stable enough to provide informed consent for research.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, neuroleptics, or acamprosate within a time sufficient for the medication to be eliminated from the body (five half-lives from last use).\n2. Pregnancy at admission (negative urine pregnancy test required).\n3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and\u002For cranial surgery.\n4. History of epilepsy.\n5. History of non-substance related psychotic disorders.\n6. Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds; and\u002For severe renal impairment, manifested as Glomerular Filtration Rate (GFR) \\\u003C= 60 ml\u002Fmin\u002F1.73 m2).\n7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.",{"count":617,"type":23},48,[619],"PHASE4","Background:\n\nChronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.\n\nObjective:\n\nTo learn more about how acamprosate affects brain function in people with AUD.\n\nEligibility:\n\nPeople aged 21 to 65 years with moderate to severe AUD.\n\nDesign:\n\nParticipants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.\n\nAcamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.\n\nParticipants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.\n\nParticipants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.\n\nParticipants may have up to three follow-up visits for 6 months.",[29],[623,624,625,626,627,628,629,630],"Multimodal","Neuroscience","Resting State","Event-Related Potentials","Artificial Intelligence","Machine Learning","ELECTROENCEPHALOGRAPHY","Acamprosate",{"date":573,"type":34},{"date":633,"type":34},"2025-05-07",{"date":161,"type":23},{"name":330,"class":84}]