[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-use-disorder-aud\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-use-disorder-aud":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,55,0,25,[9,48,71,98,129,156,181,209,231,253,282,313,335,360,389,416,442,468,506,525,546,567,595,617,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100453234","phase-2-pharmaceutically-enhanced-reinforcement-for-reduced-alcohol-and-smoking-100453234",false,"NCT05181891","Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking","PERRAS","Inclusion Criteria:\n\n1. 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days\n2. Seeking AUD treatment\n3. Seeking smoking cessation treatment\n4. Aged 18+ years\n5. DSM-5 diagnosis of AUD\n6. Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)\n7. Ability to read and speak English\n8. Ability to provide written informed consent\n9. Breath alcohol of 0.00 during informed consent\n10. Provision of at least 1 EtG-positive urine test at any time during the induction period and at least one COT-positive urine test at any time during the induction period; and\n11. Attended at least 4 of 6 possible visits during the induction period.\n\nExclusion Criteria:\n\n1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal\n2. Currently receiving any pharmacotherapy for alcohol\n3. Currently receiving any pharmacotherapy for smoking\n4. No suicide attempt in the last 20 years and\n5. Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.",true,"ALL","18 Years",{"count":21,"type":22},205,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.",[28,29],"Alcohol Use Disorder (AUD)","Nicotine Use Disorder",[31,32,33,34,29],"Alcohol Use Disorder","Contingency Management","Incentives for Sobriety","Varenicline","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2022-07-11",{"date":43,"type":22},"2027-05-01",{"name":45,"class":46},"Washington State University","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100637042","optimizing-smart-technology-for-addiction-recovery-100637042","NCT07573540","Optimizing Smart Technology for Addiction Recovery","Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder","STAR","Inclusion Criteria:\n\n* meet criteria for alcohol use disorder with at least moderate severity (\\>= 4 DSM-5 criteria)\n* in initial remission with most recent use of alcohol between 1 week and 3 months in the past\n* able to read English\n* have a smartphone and cellular plan that supports STAR use (Apple iOS or Android)\n\nExclusion Criteria:\n\n* medical or psychiatric co-morbidities that preclude use of a smartphone",{"count":57,"type":22},416,[59],"NA","The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:\n\n* help people to improve their health\n* make changes in people's lives to address alcohol and substance use\n\nParticipants will:\n\n* complete surveys\n* use a recovery-support digital therapeutic system",[31,28],"2026-06-22",{"date":64,"type":39},"2026-06-25",{"date":66,"type":39},"2025-09-24",{"date":68,"type":22},"2029-07-31",{"name":70,"class":46},"University of Wisconsin, Madison",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100568272","phase-2-suvorexant-for-treatment-of-aud-and-ptsd-100568272","NCT06679062","Suvorexant for Treatment of AUD and PTSD","A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","SUV","Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7\u002F-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7\u002F-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s\u002Fhe will lose his\u002Fher housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7\u002F-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\\u003C moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7\u002F-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST\u002FALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.","21 Years","65 Years",{"count":82,"type":22},76,[25],"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.",[28,86,87],"Post Traumatic Stress Disorder (PTSD)","Insomnia","2026-06-18",{"date":90,"type":39},"2026-06-23",{"date":92,"type":39},"2025-07-16",{"date":94,"type":22},"2027-03",{"name":96,"class":46},"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance",2,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":47},"100614420","deaf-cbt-ts-to-reduce-suicide-risk-100614420","NCT07279363","Deaf CBT-TS to Reduce Suicide Risk","Cognitive Behavioral Therapy for Treatment-Seeking to Improve Treatment Engagement and Reduce Suicide Risk Among Deaf Individuals","Inclusion criteria:\n\n* adult (aged 18 years or older)\n* Self-identify as Deaf or hard of hearing (any degree of hearing loss)\n* Primary method of communication is American Sign Language\n* Positive screen for one or more mental health disorders including depression (PHQ-9 \\> 10), anxiety (GAD-7 \\> 10), posttraumatic stress disorder (PCL-5 \\> 31), insomnia (ISI \\> 15), or alcohol use disorder (AUDIT \\> 16)\n* No current professional mental health or alcohol specialty treatment (e.g., counseling, psychiatric services) per standardized self-report\n* Access to video chat technology with internet and webcam.\n\nExclusion criteria:\n\n* unable to communicate with the researcher in American Sign Language\n* current alcohol withdrawal necessitating medical evaluation\n* current psychiatric impairment necessitating emergency services or inpatient admission (i.e., imminent danger of harm to self or others)\n* unable to comprehend the nature of the study",{"count":106,"type":22},110,[59],"The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are:\n\n* Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors?\n* Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use?\n* Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress?\n* Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors.\n\nParticipants will:\n\n* Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment.\n* Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months\n* Complete two follow-up assessments in 2 and 4 months.",[110,111,112,87,28,113],"Depression - Major Depressive Disorder","Anxiety","PTSD - Post Traumatic Stress Disorder","Suicide Ideation",[115,116,117,118,119],"Deaf","Mental Health","Treatment-Seeking","Suicide","Cognitive Behavioral Therapy for Treatment-Seeking","NOT_YET_RECRUITING","2026-06-17",{"date":62,"type":39},{"date":124,"type":22},"2026-09",{"date":126,"type":22},"2029-05",{"name":128,"class":46},"University of Rochester",{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":80,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100635962","phase-1-tirzepatide-s-dopaminergic-effects-in-alcohol-use-disorders-aud-100635962","NCT07559500","Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)","Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD), a Phase 1b Study","* INCLUSION CRITERIA:\n\nHealthy Volunteer Participants\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n\nAUD Participants\n\nTo be eligible, individuals with AUD must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. DSM 5 diagnosis of mild to moderate AUD.\n6. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n7. Minimum 2-year history of heavy drinking (SAMSHA s criteria for heavy drinking: for men 5 or more drinks\u002Fday on at least 5 different days per month; and for women 4 or more\n\n   drinks\u002Fday on at least 5 different days per month.\n8. Non treatment seeking AUD participants.\n\nEXCLUSION CRITERIA:\n\nAll Participants (Healthy Volunteers and AUD)\n\n1. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI\n2. Cannot lie comfortably flat on his\u002Fher back for up to 2 hours in the PET\u002FMRI scanner.\n3. BMI \\\u003C23 or \\>35 (but no more than 500 lbs). The PET\u002FMRI scanner bed is tested to a weight limit of 500 lbs.\n4. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n5. Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n6. Women using oral contraceptives (Part 2 of study). Women of childbearing age who are taking oral contraceptives will be required to switch to a non-oral hormonal contraceptive method (ie implants, injections, or IUDs) or add a barrier method (condoms) for the duration of the study and for 4 weeks after the last dose of study drug after explaining to them that Tirzepatide could make contraceptive less effective. We will not provide nonoral contraceptive medications to participants.\n7. Severe head trauma with loss of consciousness \\> 60 minutes\n8. Current severe mental illness (schizophrenia, bipolar disorder).\n9. Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or suicidal thoughts item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n10. Thyroid cancer or family history of thyroid cancer or personal or family history of multiple endocrine neoplasia syndrome type-2 (MEN-2).\n11. History for cerebral aneurysm.\n12. Past or present history of chest pain and trouble breathing with activity.\n13. History of Heart Disease, Hypertension or Cardiovascular disorders.\n14. History of seizures, anxiety, panic attacks, psychosis or glaucoma which are contraindicated with receiving methylphenidate.\n15. History of gallbladder disease, pancreatitis, gastroparesis, diabetic retinopathy, acute kidney injury (AKI), as these are contraindicated for Tirzepatide.\n16. History of allergic reaction to methylphenidate, Tirzepatide or allergic reactions to dyes or preservatives.\n17. Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer s disease, Parkinson s disease, traumatic brain injury with\n\n    loss of consciousness \\> 30 minutes, clinically significant arrhythmias except bradycardia, and HIV+).\n18. Clinically significant laboratory findings that could impact brain function or study procedures (e.g., active infections, significant EKG results, hepatic or renal failure) will be\n\n    exclusionary.\n19. Current DSM-5 diagnosis of a psychiatric disorder that required daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n20. History of moderate or severe SUD (other than nicotine or alcohol for AUD participants).\n21. Current severe depression or moderate\u002Fsevere suicidal ideation.\n22. Daily current use (past 2 months) of the following drugs\u002Fmedications are exclusionary: stimulant or stimulant-like drugs or medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; other GLP-1 or anti-diabetic drugs (e.g., insulin, sulfonylureas) medications, antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants with dopaminergic effects (bupropion, sertraline, and dopamine agonists like pramipexole and ropinirole); beta-blocker antihypertensives; antineoplastics; antipsychotics; anxiolytics (benzodiazepine or barbiturates); or lithium. Note that alcohol and cannabis use are not exclusionary but participants cannot be intoxicated on the day of study as evidence of alcohol in breathalyzer or cannabis in saliva. Caffeine and nicotine are permitted but participants will be asked to refrain from consuming caffeine or nicotine products (including cigarettes) two hours prior to the study. Antihistamines are also not exclusionary but should not be used on the day of study.\n23. \\*Non-English speakers (must also be able to read and comprehend English\n\n    * We are excluding non-English speakers since the study includes questionnaires that are validated for English and only some are available in Spanish. The fMRI paradigms also require that the subject be able to speak, read and comprehend English.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for alcohol\u002Fdrugs on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing for all participants:\n\n* If a subject s breath alcohol (\\>0.08%) screen test is positive on days involving imaging (PET\u002FMRI) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive breath alcohol screens. If subject continues to show up intoxicated they will be withdrawn.\n* If urine drug screen is positive for THC-COOH a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If we are unable to perform the saliva drug screen for any reason, the study day procedures will be postponed. If the urine\u002Fsaliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study. Saliva THC is not required for determining eligibility.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine after 3 days of rescheduling they will be excluded.",{"count":137,"type":22},176,[139],"PHASE1","Background:\n\nGlucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD).\n\nObjective:\n\nTo learn how the brains of people with AUD respond to a GLP-1 drug.\n\nEligibility:\n\nPeople aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed.\n\nDesign:\n\nThis study consists of Part 1 and Part 2.\n\nPart 1 (Imaging Procedures): Five healthy volunteers will undergo 2 to 3 combined positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) scans, with an interval of 2 to 3 weeks between scans. For each scan, a radioactive substance (tracer) will be administered intravenously. Participants will undergo PET\u002FMRI scanning to assess brain activity during resting state. Methylphenidate (Ritalin) will be administered during each scan. Each imaging session will last approximately 2 hours. Tirzepatide and placebo will not be administered in Part 1. Participants with alcohol use disorder (AUD) are not included in Part 1. The purpose of this part of the study is to assess test\u002Fretest reproducibility of the PET\u002FMRI combined scan measures.\n\nPart 2 (Randomization to Tirzepatide \\& Placebo): Participants will be randomized to receive either Tirzepatide or Placebo first. Healthy Volunteers and AUD participants will receive both treatments in a crossover design. Tirzepatide and placebo will be administered via subcutaneous injection (under the skin) once weekly for 2 to 3 weeks. This treatment period will be followed by 2 to 3 PET\u002FMRI combined imaging scans described in the next paragraph. After a washout interval of approximately 2 to 3 weeks, participants will cross over to the alternate treatment (tirzepatide or placebo), administered once weekly for 2 to 3 weeks. This second treatment period will be followed by an additional 2 to 3 PET\u002FMRI scans. Participants may receive up to 3 doses of tirzepatide and 3 doses of placebo.\n\nPart 2 (Imaging Procedures): Healthy Volunteers and participants with an AUD will undergo PET\u002FMRI scans at two time points: following tirzepatide administration and following placebo administration. For each scan a radioactive substance (tracer) will be administered intravenously. Brain activity will be measured during PET\u002FMRI acquisition during resting state. Methylphenidate will be administered during 1 of the scans at each time point. Each imaging session will last approximately 2 hours. Participants will wear a device to track their activity for at least 1 week before each set of scans. They will have tests of their thinking, memory, and attention.",[28],[143,144,28,145,146],"Tirzepatide","Dopamine","Normal Physiology","GLP-1","2026-06-16",{"date":121,"type":39},{"date":150,"type":39},"2026-05-20",{"date":152,"type":22},"2031-12-31",{"name":154,"class":155},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":47},"100553283","phase-1-suvorexant-for-alcohol-use-disorder-aud-neural-mechanisms-100553283","NCT06484075","Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms","* INCLUSION CRITERIA:\n* All Participants\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, ages 18-75 years old.\n* Ability to understand and the willingness to sign a written informed consent document.\n\n  * AUD Participants\n\nTo be eligible to participate in this study, an individual with AUD must meet all of the \"All Participants\" inclusion criteria (listed above) and also meet the following criteria:\n\n* DSM 5 diagnosis of moderate or severe AUD.\n* Participants seeking treatment for their AUD.\n* Current AUD with minimum 5-year lifetime history of heavy drinking (SAMSHA's criteria for heavy drinking: for men 5 or more drinks\u002Fday on at least 5 different days per month; and for women 4 or more drinks\u002Fday on at least 5 different days per month).\n* Last alcohol use within the 7 days prior to enrollment in the Natural History protocol 14AA0181.\n* Self-reported insomnia\u002Fsleep problems: PSQI score \\> 4 and\u002For endorsing \"problems falling asleep or staying asleep throughout the night\".\n* Ability to take oral medication and be willing to adhere to the suvorexant\u002Fplacebo regimen.\n* Agreement to commit to at least 28 days, and up to 40 days, inpatient stay (starting from Natural History protocol enrollment).\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nEXCLUSION CRITERIA:\n\n-All Participants\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI.\n* Cannot lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner.\n* Body weight \\> 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.\n* Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n* Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n* Severe head trauma with loss of consciousness \\> 60 minutes.\n* Chronic recurrent primary psychotic disorders like schizophrenia and bipolar 1 disorder.\n* Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or 'suicidal thoughts' item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n* Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer's disease, Parkinson's disease, traumatic brain injury, clinically significant arrhythmias except bradycardia, and HIV+).\n* Hepatic enzymes (ALT\u002FGPT, AST\u002FGOT, Total Bilirubin, Direct Bilirubin) that are \\>5x the upper limit of normal, indicating severe hepatic impairment.\n\n  * Non-English speakers (must also be able to read and comprehend English).\n\n    * The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since it includes the administration of questionnaires, surveys and assessments that are validated for English; only some are available in Spanish. In addition, our fMRI paradigms require that the subject be able to speak, read and comprehend English.\n\n      * AUD Participants\n\nAn individual with AUD who meets any of the \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current daily use of stimulant medications, modafinil, wellbutrin, naltrexone, antipsychotics, or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan).\n* Current benzodiazepine, opioids, or stimulant misuse (must have misused 5+ days\u002Fweek for \\>1 year, and most recent use must have been within 7 days of inpatient admission).\n* Current severe substance use disorders (other than alcohol, cannabis, nicotine or caffeine). If a subject had a severe SUD (other than alcohol, cannabis, nicotine or caffeine), they must be in remission for at least 6 months prior to enrollment.\n* Major medical problems that are contraindicated for the use of suvorexant (narcolepsy, severe obstructive sleep apnea or severe chronic obstructive pulmonary disease, REM behavioral disorder) as determined by history and clinical exam.\n\nNote that AUD subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing:\n\n-If a subject's urine drug\u002Fbreath alcohol (\\>=0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed until BrAC \\\u003C0.08. This is not expected to happen in most cases especially since participants will have been detoxifying for 1-5 days (possibly longer) and should no longer test positive for BrAC at this point. After initial screening under 14AA0181, subjects will be in the inpatient unit detoxifying.\n\n* If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed. However, there are reports that THC can still be detected in saliva even eight days after cessation of drug use. Because of this, AUD subjects may proceed with study day testing procedures even if saliva results for THC are positive. If any AUD participants test positive for saliva THC-COOH, we may include those results as a covariate in our statistical analyses.\n* If any other urine results are positive, we may include those results as a covariate in our statistical analyses. It is important to note that the subjects will have been in the inpatient unit detoxifying from alcohol and won't have access to drugs of misuse during this time. Positive results could be indicative of slow metabolizers of drugs and subject may stay enrolled and participate in the imaging scans.\n\nWe minimized exclusion criteria pertaining to current medication use in the AUD group participants to make recruitment feasible and so the outcome can be better generalized to vulnerable AUD populations which have high rates of comorbid mental and physical illness requiring medication. Note however that although current daily use of naltrexone is an exclusion per above, once the imaging scans and study drug dosing are completed, standard of care treatment will be started a few days prior to discharge and this could include taking naltrexone daily. This will not be considered a violation or non-compliance or deviation from criteria listed above once the imaging studies are complete. Standard of care may start within 24 hours of last study drug medication dose or last brain imaging scan under the current protocol, whichever happens last. This treatment is initiated for a few days under the 14AA0181 Natural History protocol prior to discharge from the unit.\n\n-Control Participants\n\nA control individual who meets any of the criteria listed under \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current DSM-5 diagnosis of a psychiatric disorder that requires\u002Frequired daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n* History of moderate or severe substance use disorders (other than nicotine or caffeine).\n* The following current chronically used (past 2 months) medications are exclusionary: stimulant or stimulant-like drugs and medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antihistamines (sedating); beta-blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics (benzodiazepine or barbiturates); lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos); sedatives\u002Fhypnotics, systemic steroids. Note that nicotine and\u002For caffeine is not exclusionary.\n\nWhen developing this protocol to include healthy volunteers, we needed a population not taking medications that could impact our interpretation of dopamine level measurements, since we are hoping to get estimates of 'baseline' dopamine levels in this control population.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing in HV participants:\n\n* If a subject's urine drug\u002Fbreath alcohol (\\>0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive urine drug\u002Fbreath alcohol screens. If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If the urine\u002Fsaliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.\n* If a participants urine drug screen test is positive for marijuana (urine drug screen positive for THC-COOH) on the day of the scan, we will then perform a saliva drug screen to verify if THC is present. If positive, procedures will be postponed until it becomes negative.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine they will be excluded.","75 Years",{"count":164,"type":22},180,[139,25],"Background:\n\nAlcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.\n\nObjective:\n\nTo see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.\n\nEligibility:\n\nPeople aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD.\n\nSuvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.\n\nParticipants will wear a device that looks like a wristwatch to track their movements during their clinic stay.\n\nParticipants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.\n\nParticipants will have tests to assess their thinking, memory, and attention. They will have sleep studies.\n\nImaging scans and other tests will be repeated at the end of the study.\n\nHealthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.\n\n...",[168,28],"Healthy Volunteers",[170,171,172,173,28,174],"Suvorexant","Sleep","Dopamine D2R","Dopamine D1R","Alcohol Craving",{"date":121,"type":39},{"date":177,"type":39},"2024-11-21",{"date":179,"type":22},"2029-12-31",{"name":154,"class":155},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":47},"100631676","phase-2-oea-for-young-adults-with-alcohol-use-disorder-100631676","NCT07503782","OEA for Young Adults With Alcohol Use Disorder","Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder","Inclusion Criteria:\n\n* Age 18 to 25.\n\nCall study team for additional screening and information.","25 Years",{"count":190,"type":22},42,[25],"The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive function, and alcohol use in young adults ages 18 to 25 with alcohol use disorder (AUD). The main questions it aims to answer are:\n\n* Does OEA reduce peripheral markers of immune activation (IL-6, TNF-α, IL-1β, and LPS)?\n* Does OEA alter oral microbiome composition?\n* Does OEA improve neurocognitive measures of reward sensitivity and impulsivity?\n\nResearchers will compare OEA to a placebo (a look-alike substance with no active ingredient) to determine whether OEA improves biological and behavioral outcomes associated with AUD.\n\nParticipants (N = 42) will:\n\n* Be randomly assigned to receive 300mg TRIPTI (providing 250 mg\u002Fday of OEA) or placebo for 6 weeks.\n* Provide blood, saliva, and urine samples\n* Complete cognitive testing and questionnaires\n* Report alcohol use during the study\n* Attend in-person study visits for monitoring and assessments\n\nThis randomized, double-blind, placebo-controlled pilot trial will provide preliminary data on the potential efficacy of OEA as a multi-system intervention for young adults with AUD.",[28],[195,196,197,198,199],"OEA","oleoylethanolamide","AUD","Oral microbiome","Alcohol","2026-06-11",{"date":202,"type":39},"2026-06-15",{"date":204,"type":22},"2026-08-01",{"date":206,"type":22},"2031-03-31",{"name":208,"class":46},"Medical University of South Carolina",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":47},"100630526","imaging-phosphodiesterase-4b-pde4b-in-people-with-psychiatric-disorders-with-positron-emission-tomography-pet-and-the-radiotracer-18fpf974-100630526","NCT07488819","Imaging Phosphodiesterase 4B (PDE4B) in People With Psychiatric Disorders With Positron Emission Tomography (PET) and the Radiotracer [18F]PF974","Imaging PDE4B in People With Psychiatric Disorders With PET and the Radiotracer [18F]PF974","Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent.\n2. Is able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff.\n3. Men or women, aged 18 to 70, at screening.\n4. In good general health as evidenced by medical history, physical examination, electrocardiogram, serum\u002Furine biochemistry, hematology, and serology tests.\n5. Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (SCID-5) ascertained diagnosis, confirmed by the Principal Investigators).\n6. Participants with AUD will meet the following drinking criteria: males will drink \\> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \\> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake.\n7. Participants with PTSD will have a current diagnosis of PTSD according to DSM-5 criteria (CAPS-5 ascertained diagnosis, confirmed by the Principal Investigators. TC subjects must have a DSM-5 criteria traumatic event with no PTSD diagnosis.\n8. Healthy control subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., \\>4 drinks\u002Fday for men; \\>3 drinks\u002Fday for women) in the last 30 days. Subjects who have have a DSM-5 criteria traumatic event with no PTSD diagnosis may also be considered healthy controls for Aim 1.\n9. Renal function and hepatic function will be within normal limits (for age and sex) on the laboratory tests. Elevated liver enzymes for individuals with alcohol use disorder are permitted at the discretion of the study physician.\n\nExclusion Criteria:\n\n1. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary).\n2. Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder.\n3. Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\\*) and past or current psychotic symptoms.\n4. Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data; No subject will be asked to stop taking medication to participate in the study. Participants who are regularly taking P-gp and BCRP inhibitors will be excluded.\n5. Pregnancy or lactation.\n6. Blood donation within eight weeks of the start of the study.\n7. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).\n8. Unable to safely discontinue or hold aspirin and other NSAID use.\n9. MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects\u002Ffragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).\n10. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers.\n11. Subject who has current, past, or anticipated exposure to radiation in the work place within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.\n12. Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.\n13. History of complicated alcohol withdrawal including history of delirium tremens; seizure, hospitalization for withdrawal.\n14. A CIWA score ≥8 at intake or on scan day.\n15. Subjects who are, in the opinion of the study physician, unable to safely abstain from alcohol overnight prior to their study visits.\n16. Subjects with a significant history of repeated alcohol withdrawal, defined as 4 or more medicated detoxifications in the previous 5 years","70 Years",{"count":218,"type":22},160,"OBSERVATIONAL","Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer \\[18F\\]PF974",[222,28],"Post-Traumatic Stress Disorder, PTSD","2026-06-10",{"date":200,"type":39},{"date":226,"type":39},"2025-07-07",{"date":228,"type":22},"2032-03-01",{"name":230,"class":46},"Yale University",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":97},"100526550","phase-1-influence-of-mavoglurant-on-alcohol-craving-and-drinking-in-heavy-drinkers-100526550","NCT06136195","Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers","Inclusion Criteria:\n\n1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).\n2. Ability to read English at 6th grade level or higher.\n3. Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).\n4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).\n\nExclusion Criteria:\n\n1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.\n2. Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.\n3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.\n4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm\u002Frisk behaviors (e.g. suicidal\u002Fhomicidal risk) a licensed clinician will be consulted immediately.\n5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.\n6. Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.\n7. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \\> 3 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine \\>2.0 times ULN.\n8. Neurological trauma or disease, delirium or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and Principal Investigator, may put the patient at risk because of participation in the study.\n9. Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.\n10. Women who are pregnant or nursing.\n11. Participants who refuse to use a reliable method of birth control.\n12. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n13. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n14. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.\n15. Subjects who have donated blood within the past 6 weeks.","50 Years",{"count":239,"type":22},63,[139],"The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.",[243,244,28],"Alcohol Consumption","Heavy Drinker","2026-06-04",{"date":247,"type":39},"2026-06-08",{"date":249,"type":39},"2024-07-01",{"date":251,"type":22},"2027-05-31",{"name":230,"class":46},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":260,"minAge":19,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100566255","effectiveness-of-nurse-conducted-brief-intervention-ncbi-supplemented-with-mobile-for-preventing-alcohol-use-disorders-100566255","NCT06652802","Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile for Preventing Alcohol Use Disorders","Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile-based Application for Monitoring and Relapse Prevention in Patients With Alcohol Use Disorders: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients.\n* Aged between 18 and 59 years.\n* Diagnosis of alcohol dependence use disorder based on ICD-10 criteria.\n* Patients with an Android smartphone and the ability to use mobile application.\n\nExclusion Criteria:\n\n* Female patients\n* Comorbid other substance abuse, except tobacco.\n* Comorbid major mental illness \u002Fphysical illness.","MALE","59 Years",{"count":263,"type":22},74,[59],"The study is aimed to find out that combining Nurse-Conducted Brief Intervention (NCBI) with a Smart Mobile is better than Nurse-Conducted Brief Intervention (NCBI) only in preventing relapse among Alcohol Use Disorder patients. The high relapse rates among alcohol disorder patients may be benefitted by new technology using application for improved outcomes in managing and preventing alcohol addiction relapse.",[28],[268,269,270,271,272],"Alcohol Use Disorders (AUDs),","A Randomized controlled trial","Gastroenterology,","CIWA,","Nurse-Conducted Brief Intervention (NCBI)","2026-06-03",{"date":275,"type":39},"2026-06-05",{"date":277,"type":22},"2026-12-01",{"date":279,"type":22},"2028-06-30",{"name":281,"class":46},"University of Pittsburgh",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":291,"conditions":292,"keywords":296,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100637543","high-intensity-use-of-urgent-and-emergency-care-a-mixed-methods-study-100637543","NCT07630012","High Intensity Use of Urgent and Emergency Care: A Mixed-Methods Study","High Intensity Use of Urgent and Emergency Care: a Mixed-methods Study Exploring Needs, Experiences and Priorities to Co-produce a Preventative Intervention Model","Inclusion Criteria:\n\nAdults aged 18 or over who have been identified as experiencing high intensity use of urgent and emergency care services at University Hospitals Dorset, defined as five or more unplanned contacts within a 12-month period Adults aged 18 or over who provide unpaid care or support to someone who experiences high intensity use of urgent and emergency care services Health and social care professionals aged 18 or over involved in urgent and emergency care pathways at University Hospitals Dorset, Dorset HealthCare, Dorset Council or voluntary sector partner organisations Able to provide informed consent Willing to take part in an audio-recorded interview-\n\nExclusion Criteria:\n\nUnder 18 years of age Unable to provide informed consent Currently experiencing an acute mental health crisis requiring immediate clinical intervention Known history of violence or aggression towards health and social care professionals Currently receiving inpatient treatment at the time of recruitment No direct involvement in urgent and emergency care pathways at the participating organisations (professionals only)",{"count":290,"type":22},80,"This study aims to understand the health and social care needs and experiences of adults who frequently use urgent and emergency care services in Dorset. Using a mixed-methods design, the study combines analysis of non-patient-identifiable business intelligence data with qualitative interviews and co-production activities. The business intelligence data contextualises patterns of high intensity service use and informs participant identification. Qualitative interviews will explore the personal, social and system-level factors that contribute to frequent attendance. Co-production activities with an advisory group, supported by The Lantern Trust in Weymouth, will use these findings to develop a preventative intervention model grounded in lived experience. The study will recruit up to 50 patients, up to 10 carers and up to 20 health and social care professionals. The findings will contribute to the development of more effective, person-centred approaches to supporting people who frequently use urgent and emergency care services and will inform national and local policy in this area.",[293,294,295,116,28],"High Intensity Use of Urgent and Emergency Care","Emergency Medicine","Health Inequalities",[297,298,299,300,301,302,303,304],"High intensity use","Frequent attenders","Urgent and emergency care","Mixed methods","Co-production","Qualitative research","Health and social care needs","Preventative intervention","2026-06-01",{"date":275,"type":39},{"date":308,"type":22},"2026-09-01",{"date":310,"type":22},"2029-04-01",{"name":312,"class":46},"Bournemouth University",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100636864","identification-and-molecular-characterisation-of-urban-environmental-stress-patterns-affecting-mental-illness-100636864","NCT07571226","Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness","Inclusion Criteria:\n\n1. Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;\n2. Patients with mental disorders aged 18-60 years, with a balanced gender ratio;\n3. Normal intelligence and ability to use a smartphone running the Android operating system;\n4. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n5. Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score \\>7 or a Hamilton Anxiety Rating Scale (HAMA-14) score \\>7.;\n6. Voluntary participation in this study and signing of informed consent;\n7. For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.\n\nInclusion Criteria for Healthy Control Group\n\n1. Healthy subjects aged 18-60 years, with a balanced gender ratio;\n2. Normal intelligence and ability to use a smartphone running the Android operating system;\n3. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n4. Voluntary participation in this study and signing of informed consent.\n\nExclusion Criteria:\n\n1. Currently taking opioid medications;\n2. Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;\n6. HAMD-17 item 3 (suicide) \\>3 points (severe suicidal behavior);\n\nExclusion Criteria for Healthy Control Group\n\n1. Currently using benzodiazepines or opioid medications;\n2. Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers, or not reaching steady-state drug concentration before the study;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.","60 Years",{"count":321,"type":22},680,"Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space.\n\nThis study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the \"'StreetMind'\" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses.\n\nThe study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.",[324,325,28],"Major Depressive Disorder (MDD)","Anxiety Disorder","2026-05-31",{"date":273,"type":39},{"date":329,"type":39},"2026-04-10",{"date":331,"type":22},"2029-05-30",{"name":333,"class":46},"Huashan Hospital",3,{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":80,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":97},"100639603","evaluation-of-a-virtual-reality-based-version-of-the-multiple-errands-test-in-alcohol-use-disorder-100639603","NCT07593664","Evaluation of a Virtual Reality-based Version of the Multiple Errands Test in Alcohol Use Disorder","Evaluation of a Virtual Reality-based Version of the Multiple Errands Test for the Assessment of Executive Functions in Alcohol Use Disorder","EVIMETAL","Inclusion Criteria:\n\n* written consent\n* Normal or corrected vision and hearing\n* Membership or entitlement to a social security plan\n* spoken and written French\n* third party liability insurance\n\nfor patients only :\n\n* at least 6 criteria for AUD based on the Diagnostic and statistical manual of mental disorders\n* At the end of withdrawal: treatment with a diazepam equivalent of ≤ 20 mg\u002Fday\n\nExclusion Criteria:\n\n* under tutorship\u002F judicial protection\n* Sensory or motor impairment (impeding the use of virtual reality and\u002For mobility)\n* Severe neurological disorder (such as dementia or Korsakoff's syndrome)\n* Photosensitive epilepsy (contraindication for the use of virtual reality)\n* Any other condition deemed incompatible with the study, at the investigator's discretion\n* Montreal Cognitive Assessment (MoCA) score \\\u003C 10 (severe cognitive impairment)\n* Breastfeeding or pregnant women\n* Familiarity with the supermarket visited during the MET test\n\nFor controls only :\n\n* History of alcohol use disorder\n* score ≥ 8 on the Alcohol Use Disorders Identification Test\n* Score on the Frontal Assessment Battery \\\u003C 16 (or \\\u003C 15 if education is below secondary level)",{"count":344,"type":22},90,[59],"The goal of this study is to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive functions in patients with alcohol use disorder (AUD).\n\nMore specifically, the project aims to:\n\n1. evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD.\n2. establish whether the virtual version of the test is sensitive enough to detect patients with or without an executive function deficit.\n\nAll participants will perform the original version (in a real-life supermarket) and the virtual version of the test (in a virtual reality environment).\n\nPerformance in the two versions of the test will be compared. Participants will also complete a battery of neuropsychological tests and questionnaires.",[28],[349,350,351,31],"Multiple Errands Test","Executive functions","Virtual reality","2026-05-18",{"date":150,"type":39},{"date":355,"type":22},"2026-05",{"date":357,"type":22},"2028-06",{"name":359,"class":46},"Hôpital le Vinatier",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":334},"100577854","metabolome-and-gut-microbiome-changes-during-smoking-cessation-in-long-term-drug-therapy-in-a-therapeutic-community-100577854","NCT06803706","Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community","Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness to quit smoking\n* willingness and ability to consent\n\nInclusion criteria for healthy controls :\n\n* minimum age of 18 years\n* sufficient knowledge of the German language\n* willingness and ability to consent\n\nExclusion Criteria:\n\n* lack of consent, inability to provide informed consent\n* age below 18,\n* acute psychotic symptoms or acute suicidal tendencies\n* cardiovascular disease\n* pregnancy or breastfeeding\n* severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score \\\u003C20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy)\n* probiotic intake within the last 6 months,\n* ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study\n* prior participation in a smoking cessation programme",{"count":368,"type":22},150,[59],"Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.\n\nObjectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.\n\nMethods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.\n\nA cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.",[372,28,373,374],"Substance Use Disorder (SUD)","Nicotine Addiction","Healthy Adult Participants",[376,377,378,379,380],"Metabolomics","Gut microbiome","Substance use disorder","nicotine addiction","smoking cessation","2026-05-15",{"date":352,"type":39},{"date":384,"type":39},"2025-05-05",{"date":386,"type":22},"2026-10-28",{"name":388,"class":46},"Sigmund Freud PrivatUniversitat",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":47},"100589054","assessing-the-impact-of-dtms-on-neural-targets-associated-with-alcohol-use-disorder-100589054","NCT06949423","Assessing the Impact of dTMS on Neural Targets Associated With Alcohol Use Disorder","Accessing the Impact of Deep TMS Neuromodulation on Neural Circuits Associated With Alcohol Use Disorder","NEST-A","Inclusion Criteria:\n\n* Age 18-75.\n* Current DSM-5 diagnosis of moderate to severe AUD (\\≥4 diagnostic symptoms).\n* Ability to obtain a Motor Threshold (MT) will be determined during the screening process.\n* Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.\n* Able to read, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.\n* If on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.\n* Fluency in English.\n\nExclusion Criteria:\n\n* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device\u002Fobjected in the head and body within 30 cm of the treatment coil.\n* General medical condition, disease or neurological disorder that interferes with the assessments or participation.\n* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.\n* Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.\n* Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder.\n* A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.\n* Severe impediment to vision, hearing and\u002For hand movement, likely to interfere with the ability to follow study protocols.\n* Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).\n* Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold\n* Acute or unstable chronic illness.\n* Current or lifetime history of bipolar disorder or psychosis",{"count":398,"type":22},100,[59],"The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.",[28,402],"Transcranial Magnetic Stimilation",[404,405,406,407],"Veterans","Deep Transcranial Magnetic Stimulation (dTMS)","Neuroimaging","Relapse","2026-05-12",{"date":381,"type":39},{"date":411,"type":39},"2025-12-17",{"date":413,"type":22},"2030-06-30",{"name":415,"class":46},"Stanford University",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":80,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":47},"100604386","phase-2-cannabidiol-as-an-adjunct-treatment-for-alcohol-withdrawal-and-craving-100604386","NCT07148843","Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving","Inclusion Criteria\n\n* Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder\n* Age 21-65\n* Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning (i.e., unable to attend work or engage in typical activities) AND\u002FOR required medications to manage symptoms.\n* Drinking at least 8 drinks a day over the two weeks prior to screening.\n* Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen\n* Shipley vocabulary score \\> 18, corresponding to 5th grade reading level.\n* Demonstrated understanding of informed consent and ability to consent to participation in the study.\n\nExclusion Criteria\n\n* Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe gastritis, hemoptysis, hematochezia, or melena.\n* Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission\n* Regular use (e.g., more than twice a week) of cannabis or CBD products.\n* Regular use of benzodiazepines (e.g., twice a week or more) within the last three months\n* Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including Cannabis Use Disorder (except for alcohol and tobacco)\n* Urine drug screen indicating the presence of substances other than cannabis at screening.\n* Unstable and\u002For compromising medical or psychiatric conditions that would interfere with participant safety as determined by study physician.\n* Current pregnancy\n* BMI \\\u003C17\n* History of anorexia nervosa or bulimia in the past 2 years\n* History of seizures or seizure disorder outside of alcohol-withdrawal related seizures\n* Systolic blood pressure (SBP) \\> 180, Diastolic Blood Pressure (DBP) \\> 120 or pulse \\> 120 during screening or upon admission\n* Any of the following laboratory values during screening or upon admission:\n\n  * AST \\> 165 U\u002FL (normal range 19-55)\n  * ALT \\> 216 U\u002FL (normal range 19-72)\n  * Alkaline phosphatase \\> 378 U\u002FL (normal range 38-126)\n  * Total bilirubin \\>2.5 mg\u002Fdl (normal values=0.3-1.0 mg\u002FdL)\n  * Non-fasting glucose \\> 250 mg\u002Fml (normal range 65-179)\n  * Hematocrit \\\u003C 38 % (normal range 41-53)\n  * Hemoglobin \\\u003C 12 g\u002Fdl (normal range 13.5-17.5) or any other laboratory value significantly outside the normal range\n* Use of a prescription medication (except for birth control prescriptions) within 14 days of study entry, which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication in which CYP2C9, CYP2C19, CYP1A2, CYP2B10, or CYP3A4 enzymes are major metabolizers.\n* ECG with corrected QT interval (QTC) \\>\u002F= 500 ms and\u002For presence of clinically significant abnormality\n* Participation in other clinical trials within the past 60 days\n* Court-mandated participation in alcohol treatment or pending incarceration",{"count":423,"type":22},105,[25,425],"PHASE3","Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.",[28,428,429],"Withdrawal From Addictive Substance; Detoxification","Craving",[431,432,433],"alcohol abstinence","alcohol withdrawal treatment","detoxification","2026-04-30",{"date":436,"type":39},"2026-05-01",{"date":204,"type":22},{"date":439,"type":22},"2030-10-31",{"name":441,"class":46},"Johns Hopkins University",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":467,"locationsCount":4},"100599726","testing-a-music-listening-mhealth-intervention-for-stress-reduction-in-early-recovery-calmify-ii-100599726","NCT07088237","Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery (CalmiFy II)","Testing a Music Listening mHealth Intervention for Stress Reduction in Early Recovery","CalmiFy II","Inclusion Criteria:\n\n* Subject can and has signed an Institutional Review Board (IRB) approved informed consent form (ICF).\n* Age ≥18 and ≤35 years.\n* In early-stage recovery for alcohol use (within 12 months)\n* Own a smartphone with a data plan\n* Not experiencing symptoms of severe depression\n* Not experiencing thoughts of suicide\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for alcohol use disorder (AUD)\n* Not currently taking medication treatment for opioid use disorder (OUD)\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Currently experiencing symptoms of severe depression\n* Currently experiencing thoughts of suicide\n* Currently taking medication treatment for opioid use disorder (OUD)\n* Are unable to provide voluntary informed consent.\n* Cannot read or speak English.","35 Years",{"count":452,"type":22},30,[59],"The overarching goal of this study is to develop and examine the feasibility of a music-listening intervention that can be deployed in \"real time\" to regulate emotions and reduce momentary stress among young adults within the first 12 months of recovery from alcohol use disorder. The investigators design the study with two phases to address three aims: Phase I includes the first two aims. For Aim 1, the investigators will conduct formative research with a sample of young adults who have are within 12 months of recovery (N = 30) to identify features of music selections that are most effective in reducing momentary stress in real-world, ambulatory settings. For Aim 2, the investigtors will focus on developing mobile health technology that uses passive sensing and machine learning to automatically predict moments of heightened stress in real-time and suggest specific musical selections when stress is detected. During Phase II (Aim 3), the investigators will test the feasibility of a novel music-listening intervention among a second unique sample of young adults who are within 12 months of recovery from AUD (N = 30). This protocol refers only to Phase II of the larger study.",[28],[457,458,459,460],"recovery","alcohol use disorder","stress","music listening","2026-04-29",{"date":463,"type":39},"2026-05-05",{"date":277,"type":22},{"date":466,"type":22},"2028-03-01",{"name":45,"class":46},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":80,"enrollmentInfo":475,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":477,"conditions":478,"keywords":487,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":97},"100564051","computer-game-qualitative-and-megeeg-assessment-of-serotonergic-psychedelics-100564051","NCT06624137","Computer Game, Qualitative, and MEG\u002FEEG Assessment of Serotonergic Psychedelics","Computationally, Electrophysiologically, and Qualitatively Characterizing Serotonergic Psychedelics; Transdiagnostic Therapeutic and Pro-Psychotic Effects","Inclusion Criteria:\n\n* Participation in approved clinical protocol at Yale University involving potential administration of serotonergic psychedelics\n* Absence of pre-existing psychotic symptoms\n\nExclusion Criteria:\n\n* Current intoxication based on self-report\n* Any neurological, medical or developmental problem that is known to impair cognition significantly based on self-report\n* History of seizures based on self-report\n* Contraindications for MR scanning including metallic implants of any kind, pacemakers and history of accidents with metal, claustrophobia (specific to those who will participate in MRI)",{"count":476,"type":22},200,"This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine\u002FDMT, Lystergic Acid Diethylamide\u002FLSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are:\n\n1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use?\n2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs?\n3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect?\n4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics?\n\nResearchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics.\n\nParticipants will have the opportunity to do some combination of the following:\n\n1. Online computer assessments consisting of games and questionnaires that probe how participants think.\n2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered.\n3. A magnetic resonance imaging (MRI) scan.\n4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.",[479,324,28,480,481,482,112,483,484,485,486],"OCD","Healthy Volunteer","Migraine","PTSD","Addiction","Tobacco Use Disorder","Obsessive Compulsive Disorder (OCD)","Opioid Use Disorder",[488,489,490,491,492,493,494,495,496,497,498],"Psilocybin","DMT","N,N-dimethyltryptamine","Ayahuasca","Lysergic acid diethylamide","LSD","5-MeO-DMT","O-methyl-bufotenin","eeg","meg","5-Methoxy-N,N-Dimethyltryptamine","2026-04-27",{"date":436,"type":39},{"date":502,"type":39},"2024-12-12",{"date":504,"type":22},"2028-05",{"name":230,"class":46},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":80,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":47},"100521519","phase-1-the-potential-therapeutic-effects-of-psychedelic-n-n-dimethyltryptamine-dmt-on-alcohol-use-disorder-aud-100521519","NCT06070649","The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder\n* Medically healthy\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Unstable medical conditions",{"count":239,"type":22},[139],"This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.",[28,516,517],"Alcohol-Related Disorders","Alcohol Use","2026-04-26",{"date":520,"type":39},"2026-04-28",{"date":522,"type":39},"2025-08-04",{"date":204,"type":22},{"name":230,"class":46},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":188,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":97},"100475750","phase-2-lsd-treatment-for-persons-with-alcohol-use-disorder-100475750","NCT05474989","LSD Treatment for Persons With Alcohol Use Disorder","Investigating the Efficacy and Microstructural Plasticity of LSD Treatment in Patients With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo-controlled Phase II Neuroimaging Study.","LYTA","Key inclusion criteria:\n\n* Age ≥ 25 years\n* Participants must meet the DSM-5 criteria for a moderate to severe alcohol use disorder and must intend to stop or decrease their drinking for at least the duration of the study\n* Participants must have underwent an alcohol detoxification within the 60 days prior to screening or, in cases where no detoxification is necessary, must have been abstinent for at least 14 days.\n* A minimum of 4 HDD within the last 30 days before detoxification or cessation of alcohol use (a HDD is defined as 5 or more standard drinks per day for a man and 4 drinks for a woman; a standard drink is defined as 12 g of alcohol)\n\nKey exclusion criteria:\n\n* Significant alcohol withdrawal symptoms at screening\n* Participating or starting in any formal treatment for AUD from visit 1 until completion of the double-blind phase\n* Treatment with disulfiram during the study\n* Past or present diagnosis of a DSM-5 psychotic or bipolar disorder in subjects or first-degree relatives\n* Current suicidality or history of a serious suicide attempt",{"count":534,"type":22},128,[25],"Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy, and around 60% of the patients relapse in the short term after withdrawal.\n\nLysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding.\n\nThis trial will assess the efficacy and safety of two moderate to high doses of LSD to decrease alcohol consumption in patients with AUD. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for addictive disorders in Switzerland. The study will include 128 patients who have undergone detoxification. Participants will be allocated to one of the two intervention arms (1:1 allocation). Each arm comprises nine study visits (no drug administration) and two study days (involving LSD administration) within 30 weeks. Patients allocated to the control intervention (active placebo group) will receive 10 µg LSD on the first study day and either 10 or 20 µg LSD on the second study day. Patients allocated to the treatment intervention will receive 150 µg LSD on the first study day and either 150 µg or 250 µg LSD on the second study day. The dose will be retained or increased depending on the patient's individual response on the first study day. Participants in the control intervention will be offered to attend an open-label LSD session (150 µg) at week 31. The open-label phase will comprise three additional visits. This trial will further compare the effectiveness of LSD-assisted therapy in both group and individual therapeutic settings. To this end, participants in both drug conditions will be randomly assigned to group or individual settings.\n\nThe primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD during the 12 weeks following the second administration. Secondary objectives: The second aim of this study is to explore long-term changes in the cortical thickness, white matter microstructure, resting state functional connectivity (rs-FC) and cerebral blood flow (CBF) of regions associated with addiction pathophysiology. Furthermore, we will assess alterations in depressive symptoms, anxiety, and persisting effects of LSD. We will also assess biological markers of alcohol use and several predictors for treatment-response (genetics, personality traits, blinding, expectancy, and quality of acute drug effects). Lastly, we will compare LSD treatment within a group setting with treatment within an individual setting.",[28],"2026-04-23",{"date":461,"type":39},{"date":541,"type":39},"2026-01-27",{"date":543,"type":22},"2029-04-30",{"name":545,"class":46},"Felix Mueller",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":219,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":47},"100635372","process-based-psychological-processes-in-alcohol-use-disorder-a-case-control-study-using-pbat-phq-9-and-gad-7-100635372","NCT07551830","Process-Based Psychological Processes in Alcohol Use Disorder: A Case-Control Study Using PBAT, PHQ-9, and GAD-7","PBAT Addiction","Inclusion Criteria:\n\n* age ≥18, the ability to provide informed consent, no psychiatric diagnosis (for the control group).\n\nExclusion Criteria:\n\n* severe cognitive impairment, psychosis, inability to complete questionnaires.",{"count":476,"type":22},"This observational study investigates differences in psychological processes and emotional symptoms between individuals with Alcohol Use Disorder (AUD) and a non-clinical control group. PBAT, PHQ-9, and GAD-7 will be used. MANCOVA will test group differences controlling for demographics.",[28],[28,557,558,559],"Process-Based Assessment Tool (PBAT)","depression","anxiety","2026-04-22",{"date":499,"type":39},{"date":563,"type":22},"2026-06",{"date":357,"type":22},{"name":566,"class":46},"George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":80,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":581,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":47},"100439178","mpfc-theta-burst-stimulation-as-a-treatment-tool-for-alcohol-use-disorder-effects-on-drinking-and-incentive-salience-100439178","NCT04998916","MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience","Inclusion Criteria:\n\n* Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction)\n* Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V\n* Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.\n* Able to read and understand questionnaires and informed consent.\n\nExclusion Criteria:\n\n* Has metal placed above the neck\n* Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)\n* Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal\n* Has a history of claustrophobia\n* Has a history of chronic migraines\n* Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage\n* Has an unstable medical illness requiring planned medical\u002Fsurgical intervention (e.g. chemotherapy, surgical procedure)\n* Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric\u002Fsleeping medications except for stable (1 month) antidepressants\u002FSSRI's. \\[Note: this criterion is for scientific rather than safety or patient comfort reasons\\].\n* Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months\n* Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \\[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\\]\n* Has current suicidal ideation or homicidal ideation\n* Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.",{"count":574,"type":22},86,[59],"The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.",[31,578,579,580,28],"Alcohol Drinking","Substance Use","Drinking, Alcohol",[582,583,584,585,586],"Transcranial Magnetic Stimulation","Medial Prefrontal Cortex","Brain Stimulation","Non-invasive","Adult","2026-03-27",{"date":589,"type":39},"2026-04-02",{"date":591,"type":39},"2021-07-06",{"date":593,"type":22},"2026-12-31",{"name":208,"class":46},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":603,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":47},"100596064","phase-2-off-label-medications-for-alcohol-use-disorder-among-patients-with-hiv-pilot-study-3-semaglutide-100596064","NCT07040592","Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide","Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study","HARP","Inclusion Criteria:\n\n* diagnosed with HIV\n* Receive care at the Atlanta VA Healthcare System\n* Age 18 or over\n* Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen\n* Have evidence of significant alcohol use: PEth \\> 20ng\u002Fml\n* Prescribed \\>=5 medications\n* Have cell phone or reliable contact number\n* Can provide written informed consent\n\nExclusion Criteria:\n\n* Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment\n* Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive\n* Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)\n* Untreated moderate to severe opioid use disorder\n* Residence out of state\n* Inability to read or understand English\n* History of serious hypersensitivity or adverse reaction to study medication\n* Taking potentially interactive medication(s) for diabetes\n* BMI\\\u003C23\n* Diagnosis of type 1 Diabetes\n* Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease\n* Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema\n* Already prescribed the pilot medication at the time of study recruitment.","99 Years",{"count":452,"type":22},[25],"This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.",[28,608],"HIV","2026-03-20",{"date":611,"type":39},"2026-03-24",{"date":613,"type":39},"2026-01-15",{"date":615,"type":22},"2027-06-30",{"name":230,"class":46},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":630,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":47},"100372932","phase-2-alpha-1-blockade-for-alcohol-use-disorder-aud-100372932","NCT04135846","Alpha-1 Blockade for Alcohol Use Disorder (AUD)","A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD","DOXY","Inclusion Criteria:\n\n* Male or female, 18 years of age\n* Meet the DSM-5 criteria for AUD\n* Desire to reduce or quit alcohol drinking\n* Breath alcohol (BrAC) = 0.00 at each visit\n* In good health as confirmed by medical history, physical examination and lab tests\n* Willing to adhere to the study procedures\n* Understand informed consent and questionnaires in English at an 8th grade level\n\nExclusion Criteria:\n\n* Women who are breastfeeding or \u002Fpositive urine test for pregnancy\n* CrCl\\\u003C60mL\u002Fmin\n* Suicide attempt in the last three months\n* Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline\n* Current use of medication that may interact with doxazosin and\u002For yohimbine\n* History of allergy to any alpha receptor blockers\n* Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8\n* Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening\n* Treatment with any alpha-blocker\n* Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG.\n* Baseline hypotension defined as BP reading lower than 90\u002F60 mmHg\n* Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication",{"count":626,"type":22},184,[25],"The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.",[28],[631],"Alcohol use disorder, stress","2026-03-18",{"date":609,"type":39},{"date":635,"type":39},"2019-12-19",{"date":637,"type":22},"2026-08-31",{"name":639,"class":46},"Brown University",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":659,"leadSponsor":661,"locationsCount":47},"100602062","phase-2-probenecid-administration-for-alcohol-craving-and-consumption-100602062","NCT07118618","Probenecid Administration for Alcohol Craving and Consumption","Probenecid, Pannexin 1 Channels for Alcohol Use Disorder","PROB2","Inclusion Criteria:\n\n* • Male or female, ≥18 years.\n\n  * women \\>7 drinks\u002Fweek; men \\>14 drinks\u002Fweek.\n  * meet moderate to severe AUD score for DSM-5 criteria.\n  * Breath Alcohol Content (BrAC)=0.00 at each visit.\n  * in good health as confirmed by medical history, physical examination and lab tests.\n  * willing to adhere to the study procedures.\n  * understand informed consent and questionnaires in English at an 8th grade level.\n\nExclusion Criteria:\n\n* • Women who are breastfeeding or positive urine test for pregnancy.\n\n  * clinically significant medical abnormalities: unstable hypertension, clinically significant abnormal EKG, bilirubin \\>150% of the upper normal limit, ALT\u002FAST \\>300% the UNL, creatinine clearance ≤60 dl\u002Fmin\n  * meet DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses\n  * medications that reduce alcohol consumption (naltrexone, disulfiram).\n  * use aspirin (salicylates may reduce effect of probenecid), penicillin, methotrexate (may increase concentration).\n  * history of suicide attempts in the last three years.\n  * current diagnosis of a moderate or severe cannabis use disorder as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.\n  * current diagnosis of another substance disorder at any severity, other than nicotine, as assessed by self-report, SCID-E for SUD, and urine toxicology screen at baseline.\n  * current use of medications that may interact with probenecid.\n  * history of hypersensitivity to sulfa drugs.",{"count":649,"type":22},120,[25],"This study proposes a 16-week, between-subject, double-blind, randomized controlled trial (RCT) with probenecid (2g \u002Fday) compared to placebo in individuals with AUD to test if reduces craving and alcohol consumption.",[28,243,429],[197,654,429,199],"Probenecid","2026-03-14",{"date":657,"type":39},"2026-03-17",{"date":655,"type":39},{"date":660,"type":22},"2030-12-31",{"name":639,"class":46}]