[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,60,93,122,153,181,202,229,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100639366","investigating-the-effect-of-caffeine-and-alcohol-on-pupil-dynamics-100639366",false,"NCT07625358","Investigating the Effect of Caffeine and Alcohol on Pupil Dynamics","Investigating the Effect of Caffeine and Alcohol on Pupil Dynamics (PAC)","PAC","Participants must meet the inclusion criteria, as shown below, to participate in this study\n\nInclusion Criteria\n\n1. Age: 30 to 50 years of age\n2. Visual Acuity: Best Corrected Visual Acuity (BCVA) of 0.20 LogMAR or better in both eyes\n3. Ability to provide informed consent: Participants must be able to understand and sign the informed consent form\n4. Ability to consume both caffeine and alcohol: Participants must be willing and able to consume caffeine and alcohol as part of the study\n\nParticipants meeting any of the exclusion criteria, as shown in the table below, will be excluded from participation.\n\nExclusion Criteria\n\n1. Diagnosed ocular conditions: Participants with ocular or ocular movement diseases such as glaucoma, age-related macular degeneration, diabetic retinopathy, amblyopia, severe ptosis, or conditions relating to pupils: anisocoria, irregular pupil, Adie tonic, Horner's syndrome, Argyll Robertson pupil, etc. These exclude cataracts, refractive errors, and any ocular condition not affecting vision or ocular movement or obstructing the pupil.\n2. Diagnosed and unresolved neurological conditions:Stroke, unresolved traumatic brain injury, space-occupying lesions in the brain, neuropathies, demyelinating conditions, nerve palsies, etc.\n3. Diagnosed systemic conditions that may restrict the participant from drinking caffeine or alcohol: Hypertension, cardiovascular disease, liver disease, kidney disease, etc.\n4. Medications: Participants taking any medications that may interact with caffeine or alcohol, affect alertness, or cause drowsiness\n5. Previous complex intraocular eye surgery: Participants who have undergone any eye surgery other than uncomplicated refractive surgery.\n6. Pregnancy or breastfeeding: Pregnant or breastfeeding women will be excluded from the study, as caffeine and alcohol can affect the fetus or baby\n7. History of substance abuse: Participants with a history of substance abuse\n8. Allergies or sensitivities: Participants with allergies or sensitivities to caffeine or alcohol\n9. Shift work or having travelled across 2 time zones over the past 2 weeks: This is essential to avoid any impact of sleep deprivation on our outcome measures\n10. Non-consumers or light-consumers of caffeine and alcohol Participants who are light consumers of caffeine or alcohol will be excluded due to higher sensitivity to side effects.\n\nCaffeine: If less than 100 mg of caffeine per week from all sources (including coffee, soft drinks, energy drinks, chocolate, and medications) based on the CCQ\\* Alcohol: If AUDIT-C\\*\\* score less than 1\n\n11- Extremely frequent consumers Participants who are extremely frequent consumers of caffeine or alcohol will be excluded due to potential withdrawal symptoms during the required 18-hour abstinence and possible reduced sensitivity to administered doses.\n\nCaffeine: If more than 400mg of caffeine (e.g., 5 espressos) per day from all sources (including coffee, soft drinks, energy drinks, chocolate, and medications) based on the CCQ\\* Alcohol: If AUDIT-C\\*\\* scores more than 4 for men and more than 3 for women\n\nNote: Participants will complete a history update questionnaire at each laboratory visit to report any changes relevant to the exclusion criteria. If a participant no longer meets the eligibility criteria at any visit after the baseline assessment, the visit will either be rescheduled, if appropriate, or the participant will be withdrawn from the study. Reimbursement will be provided on a prorated basis.\n\n\\*CCQ: Caffeine Consumption Questionnaire\n\n\\*\\*AUDIT-C: Alcohol Use Disorders Identification Test-C",true,"ALL","30 Years","50 Years",{"count":22,"type":23},100,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this study is to understand how caffeine and alcohol affect the ocular and physiological systems, especially how the pupil (the aperture in the colored part of the eye) responds to light. It will also test whether these changes can be used to detect recent caffeine or alcohol intake using a portable eye device.\n\nThe main questions it aims to answer are:\n\n1. How does caffeine change pupil responses, eye movements, and other ocular and physiological measurements?\n2. How does alcohol change these same ocular and physiological responses?\n3. Are the effects of caffeine and alcohol different from each other?\n4. Can these changes be used to accurately identify whether someone has consumed caffeine or alcohol?\n\nResearchers will compare caffeine, alcohol, and a placebo (a look-alike drink with no active substance) to see how each affects the ocular and physiological outcomes.\n\nParticipants will:\n\n1. Attend three separate sessions where they will consume caffeine, alcohol, or a placebo (in random order)\n2. Undergo pupillary response evaluation using a handheld device that measures responses to different colored light stimuli\n3. Have their eye movements analyzed\n4. Have retinal and choroidal thickness, blood perfusion, and ocular oxygen levels measured\n5. Have basic body measurements recorded (such as pulse rate and blood pressure)\n6. Complete tests at multiple time points over 2 hours after consumption\n\nThe results of this study may help develop a quick and non-invasive way to detect recent caffeine or alcohol use for clinical and safety purposes.",[29,30,31,32,33,34,35],"Caffeine","Alcohol","Pupillary Response","Eye Movements","Optical Coherence Tomography","Optical Coherence Tomography Angiography","Physiological Responses",[29,30,37,38,39,40,41,42,43,44,45,46],"Pupillary light reflex","Pupillometry","Chromatic pupillometry","Eye movements","Oculomotor function","Optical coherence tomography","Optical coherence tomography angiography","Physiological responses","Machine learning","Non-invasive monitoring","RECRUITING","2026-05-28",{"date":50,"type":51},"2026-06-04","ACTUAL",{"date":53,"type":23},"2026-06-01",{"date":55,"type":23},"2027-11-05",{"name":57,"class":58},"National University of Singapore","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":18,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":24,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":59},"100609948","phase-2-glp-1-receptor-agonists-to-decrease-ethanol-and-cvd-risk-in-hiv-100609948","NCT07221214","GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV","GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT","GL1DER HIV RCT","Inclusion Criteria:\n\n* Ages 18-89\n* Prior diagnosis of HIV-1\n* Affiliated with Vanderbilt Comprehensive Care Clinic\n* On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.\n* Most recent absolute CD4 count ≥ 300 cells\u002Fmm3 and drawn within 12 months of study enrollment\n* BMI ≥ 23 (calculated at screening)\n* Self-report of consuming alcohol in past 90 days\n* AUDIT-C ≥ 3 (male)\u002F ≥ 2 (female)\n* Has an established stable address at which they can receive mail and can be reached for the next 6 months\n* Willing and able to complete study procedures and follow-ups\n\nExclusion Criteria:\n\n* Known allergy to semaglutide\n* Currently taking GLP-1 RA (in the past 3 months)\n* History of diabetes defined by diagnosis in Problems List in medical record\n* History of pancreatitis\n* History of gastroparesis\n* Gallbladder disease (in the past 3 months)\n* History of medullary thyroid carcinoma\n* Family history of medullary thyroid carcinoma\n* History of multiple endocrine neoplasia syndrome type 2\n* Family history of multiple endocrine neoplasia syndrome type 2\n* Cognitive inability to consent\n* Barrier to speaking, hearing, reading, or writing English\n* Pregnant or breastfeeding, or planning to become pregnant in the next 6 months\n* Too ill to complete study procedures","18 Years","89 Years",{"count":71,"type":23},200,[73],"PHASE2","The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are:\n\n1. Does semaglutide lower the average number of alcoholic beverages participants drink per week?\n2. Does semaglutide lower the average number of cigarettes participants smoke per day?\n3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and\u002For smoke tobacco?\n\nResearchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week.\n\nParticipants will:\n\n1. Take semaglutide for 3 months\n2. Visit the research clinic 3 times for checkups and tests\n3. Provide blood samples, stool samples, and saliva samples for tests.",[76,30,77,78],"HIV","Smoking Cigarette","Cardiovascular Disease Prevention",[76,80,81,82,83],"alcohol","smoking","tobacco","cardiovascular disease","2026-05-22",{"date":86,"type":51},"2026-05-26",{"date":88,"type":51},"2026-04-17",{"date":90,"type":23},"2030-01-31",{"name":92,"class":58},"Vanderbilt University Medical Center",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":100,"minAge":68,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":24,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":59},"100622303","social-media-psychosocial-support-group-in-reducing-alcohol-consumption-100622303","NCT07381868","Social Media Psychosocial Support Group in Reducing Alcohol Consumption","Social Media Psychosocial Support Group to Reduce Alcohol Consumption in Women: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult women (age 18+),\n* Had a total score ≥3 in AUDIT-C \\[suggesting at-risk drinkers (i.e., binge drinking)\\]( potential distress symptoms),\n* Able to read and understand Chinese and use an instant messaging app weekly\n\nExclusion Criteria:\n\n* Women who are undergoing psychiatric\u002Fpsychological treatment","FEMALE",{"count":102,"type":23},60,[26],"This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA) and social media psychosocial support group to reduce alcohol consumption in women.",[30,106],"mHealth Intervention",[108,109,110,111,112],"psychosocial support","alcohol consumption","adult women","social media","reduce alcohol intake","2026-05-14",{"date":115,"type":51},"2026-05-18",{"date":117,"type":23},"2026-05-01",{"date":119,"type":23},"2026-11-30",{"name":121,"class":58},"The University of Hong Kong",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":17,"sex":18,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100626378","evaluation-of-a-sexual-violence-and-intimate-partner-violence-primary-prevention-program-implemented-in-drinking-establishments-100626378","NCT07434856","Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments","The Safe Night Out Evaluation Study: Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments","Inclusion Criteria:\n\n* Aged 21 years or older (as required per California law for alcohol servers)\n* Employed and working as a bar owner, manager, or staff member of the drinking establishment that has been recruited for the study (for staff participants)\n* A customer or patron in the past month at the drinking establishment that has been recruited for the study (for patron participants)\n* Ability to speak and understand English\n\nExclusion Criteria:\n\n* Aged 20 years and under\n* Inability to speak and understand English\n* No current employment at a drinking establishment recruited for the study (for staff participants)\n* No history of visiting the drinking establishment in the past month (for patron participants)","21 Years",{"count":131,"type":23},650,"OBSERVATIONAL","The goal of this project is to evaluate the effectiveness of Safe Night Out, a community-level primary violence prevention program offered in drinking establishments in the Sacramento region of California. The main questions this project aims to answer are: 1) Does the Safe Night Out program reduce incidents of sexual violence and intimate partner violence among patrons? 2) Does the Safe Night Out program increase incidents of safety checks of patrons by staff participants? To address these questions, we will enroll 150 staff participants and 500 patron participants from 25 drinking establishments that have implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment) and 25 drinking establishments that have not implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment). Participants will complete a baseline and three 6-month follow-up assessments, until 18 month-follow-up.",[135,136,30,137],"Intimate Partner Violence (IPV)","Sexual Violence","Safety",[139,140,80,141,142],"sexual violence","intimate partner violence","bars","clubs","NOT_YET_RECRUITING","2026-02-19",{"date":146,"type":51},"2026-02-27",{"date":148,"type":23},"2026-06",{"date":150,"type":23},"2028-12",{"name":152,"class":58},"University of California, San Diego",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":18,"minAge":129,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":59},"100592508","phase-2-tirzepatide-for-alcohol-use-disorder-100592508","NCT06994338","Tirzepatide for Alcohol Use Disorder","Phase II Evaluation of Tirzepatide in Adults With Alcohol Use Disorder and Overweight or Obesity","Inclusion Criteria:\n\n1. Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)\n2. Average daily consumption of ≥40g (women) \u002F ≥ 60 g (men) per day in the 28 days prior to baseline\n3. Body mass index ≥ 27kg\u002Fm2\n4. Willingness to attend weekly medication visits and complete all study procedures\n5. Ability to read and communicate in English\n6. Age 21-65\n7. Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)\n8. Stable housing status\n\nExclusion Criteria:\n\n1. Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)\n2. Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.\n3. History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related symptoms; a CIWA score \\>9 at assessment; or a baseline score 4+ on the Prediction of Alcohol Withdrawal Severity (PAWS) scale.\n4. Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment\n5. History of chronic or acute pancreatitis\n6. History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%\n7. History of suicide attempt or report of current (past 2 weeks) active suicidal ideation\n8. Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)\n9. Evidence of a significant anxiety or depressive disorder that is currently interfering with daily functioning, based on GAD-7 and PHQ-9 scores and physician judgement. (Anxiety or depression are not exclusionary if symptoms are stable\u002Fnon-interfering with daily activities, or if the participant is receiving treatment, i.e., psychiatric medications have not changed for at least 3 months prior to baseline)\n10. Treatment for eating disorder in the past 12 months\n11. Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians\n12. History of known liver disease\n13. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\\>3x upper limit of normal range)\n14. History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer\n15. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)\n16. Weight loss \\> 5% in the 30 days prior to screening\n17. Currently enrolled in another clinical trial involving an investigational product\n18. Current contact or co-habitation with a current or former participant in the present trial\n19. Current co-habitation with a person taking GLP-1RA therapy\n20. Planned surgical procedures requiring anesthesia within 90 days post-entry into the study\n21. History of treatment with tirzepatide or a GLP-1RA within 6 months of screening\n22. Treatment with any weight loss medications (e.g., orlistat, bupropion-naltrexone) or medications known to reduce alcohol consumption (e.g., naltrexone, topiramate, acamprosate, varenicline) in the past 3 months\n23. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I or type II\n24. Estimated glomerular filtration rate (eGFR) \\\u003C60 (indicated impaired kidney function)\n25. Use of prescribed or non-prescribed medications that would preclude safe use of tirzepatide in the judgement of the study physicians\n26. Known bone, muscle, or wasting conditions (e.g., osteoporosis, sarcopenia) aa. Presence of significant or uncontrolled GI conditions (e.g., GERD) that would interfere with treatment in the judgement of study physicians bb. Any other significant disease, disorder, or finding that in the opinion of the investigator(s) may increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.\n\ncc. Currently pregnant or nursing, or inability to adhere to a reliable method of birth control (applies to female participants of childbearing age) dd. Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of \\>180\u002F110 after three successive readings ee. History of heart attack or stroke in the 6 months prior to screening ff. A pre-treatment reduction in alcohol consumption to \\\u003C 40g\u002Fday (males) or \\\u003C20g\u002Fday (females) in the interval between baseline screening and randomization","65 Years",{"count":162,"type":23},42,[73],"The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.",[166,167,30],"Alcohol Use Disorder","Obesity and Overweight",[169,170,171,30],"Tirzepatide","GLP-1","Addiction","2025-10-08",{"date":174,"type":51},"2025-10-14",{"date":176,"type":51},"2025-10-06",{"date":178,"type":23},"2026-08-31",{"name":180,"class":58},"University of Southern California",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":18,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100585498","piloting-a-biomarker-augmented-alcohol-screening-brief-intervention-and-referral-to-treatment-sbirt-program-among-hiv-affected-adolescents-and-young-adults-in-zambia-100585498","NCT06903143","Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia","Inclusion Criteria:\n\n* 16-24 years of age\n* Residing in Lusaka, Zambia\n* Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).\n\nExclusion Criteria:\n\n• Unable or unwilling to provide informed assent\u002Fconsent","16 Years","24 Years",{"count":102,"type":23},[26],"This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:\n\nSpecific aims:\n\n1. Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low\u002Fmoderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).\n2. Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.",[30],"2025-06-12",{"date":195,"type":51},"2025-06-13",{"date":197,"type":23},"2025-08-01",{"date":199,"type":23},"2026-04-30",{"name":201,"class":58},"Centre for Infectious Disease Research in Zambia",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":17,"sex":18,"minAge":68,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":59},"100528321","intestinal-microbiota-profiling-in-severe-acute-alcoholic-hepatitis-patients-100528321","NCT06159244","Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients","Intestinal Microbiota Profiling in HAA Patients","HepathAlc-IM","Inclusion Criteria:\n\n* Patients aged from 18 to 75 years, having :\n* Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg\u002Fdl)\n* Histological confirmed Alcoholic hepatitis\n* Personal consent signed to the trial\n* No exclusion criteria\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years and\u002For \\> 75 years,\n* Pregnancy or lactating females,\n* No personal consent\n* Other causes of liver disease: chronic hepatitis B (antigen HBs positive), hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, autoimmune hepatitis, primary biliary cholangitis, primary sclerosis cholangitis, alpha 1 antitrypsine deficiency, and Wilson disease.\n* Uncontrolled liver complications:\n* Upper gastrointestinal bleed by portal hypertension (4 days required for stable condition)\n* Active sepsis (4 days required for stable condition)\n* Patient currently treated by antibiotic\n* Concomitant Liver cancer (HCC) or extrahepatic malignancy\n* Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine \\>221 μmol\u002FL (\\>2.5 mg\u002FdL) or the requirement for renal replacement therapy\n* Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria\n* Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation)\n* Disseminated intravascular coagulation\n* Intestinal paralysis\n* History of liver transplantation\n\nOther general diseases or severe conditions:\n\n* HIV disease\n* Intestinal paralysis\n* Intestinal inflammatory disease (Crohn or Ulcerative colitis)\n* Clostridium difficilae infection\n* Clinical suspicion of pneumonia\n* Uncontrolled sepsis\n* Acute Alcoholic pancreatitis\n* Noncontrolled alcohol withdrawal syndrome\n* Cardiac or respiratory bad conditions","75 Years",{"count":71,"type":23},[26],"In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response.\n\nThe determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes.\n\nThe investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment.\n\nThe analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.",[215,30,216,217],"Severe Acute Alcoholic Hepatitis","Intestinal Microbiota","Corticosteroids",[219,30,216,217],"Severe acute alcoholic hepatitis","2025-05-21",{"date":222,"type":51},"2025-05-25",{"date":224,"type":51},"2023-11-15",{"date":226,"type":23},"2028-11",{"name":228,"class":58},"Centre Hospitalier Universitaire, Amiens",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":17,"sex":18,"minAge":129,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":24,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":59},"100571641","phase-2-rapid-bac-reduction-with-nutraceutical-blend-study-100571641","NCT06722898","Rapid BAC Reduction with Nutraceutical Blend Study","Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study","Inclusion Criteria:\n\n* Over age 21\n* Provide signed Informed Consent form electronically in advance of the first study date.\n* Provided signed Acknowledgement Form of what is required as part of the study, including use of Uber for transportation to and from each session.\n* Not taking certain prescription medications to be listed.\n* No history of alcohol or substance abuse issues or alcohol-related medical conditions.\n* No history of liver disease.\n* No history of significant violent behavior.\n* Uses alcohol socially on a regular basis.\n* Not naïve to consuming more than 4 drinks at one time.\n* Not pregnant or at risk for being pregnant.\n* Able to attend all three session dates.\n* Own smartphone with text messaging abilities.\n\nExclusion Criteria:\n\n* Score consistent with Alcohol Use Disorder on the Alcohol Use Disorder Identification Test (AUDIT) a 10 question self-report tool developed by the World Health Organization (WHO).\n* Ongoing or regular use of any of the following medications for medical conditions: Antabuse (disulfiram): (Slows alcohol metabolism by inhibiting the elimination of acetaldehyde), Beta-lactam antibiotics: (Some, such as cefmandole, cefoperazone, and moxalactam, can cause a disulfiram-like reaction when alcohol is consumed), Nitrates (Can cause a disulfiram-like reaction when alcohol is consumed), Sulfonylureas (Longer acting ones, such as chlorpropamide and tolbutamide, can cause a disulfiram-like reaction when alcohol is consumed, as well as Pyrazoles and isobutyramide, Inhibit ADH, which decreases the rate at which alcohol is eliminated.)\n* Current use of medications likely to be synergistic with one-time excessive use of alcohol: opioids, benzodiazepines, anti-histamines.\n* Current use of psychoactive products such as delta 8 or delta 9 tetrahydrocannabinol (THC), Kava, Kratom or psychedelic mushroom (psilocybin).\n* Current use of any illegal drug or substance, that includes, but is not limited to -cocaine, methamphetamine, MDMA (ecstasy, molly).\n* Active medical conditions that would preclude one-time excessive use of alcohol: Liver disease, diabetes mellitus, seizure disorder\u002Fepilepsy, uncontrolled hypertension, cardiac arrhythmia, Multiple Sclerosis, Schizophrenia, Traumatic Brain Injury (TBI), active peptic ulcer disease (PUD), and opioid use disorder",{"count":237,"type":23},35,[73],"Study Title: Nutritional Supplement to Rapidly Decrease Blood Alcohol Concentration (BAC): Safety and Efficacy Study Design: Double-blind, randomized, placebo-controlled clinical trial Objective: Evaluate safety and efficacy of a nutritional supplement to rapidly decrease blood alcohol concentration (BAC), alcohol-induced impairment, and hangover symptoms after excessive alcohol consumption.\n\nPrimary Outcomes:\n\nBAC reduction rate\u002Fextent (BACtrack S80™ breathalyzer) Cognitive\u002Fphysical impairment change (DRUID app™)\n\nSecondary Outcome:\n\nHangover symptom reduction (Acute Hangover Scale) Participants: 35 participants, recruited via social media Duration: 2 weeks, 2 testing sessions (4 hours each) Location: Closed facility in St. Petersburg, FL\n\nProcedure:\n\nSubjects consume standardized alcohol (1g ethanol\u002Fkg body weight) 40-minute drinking period BAC and impairment measurements Administration of test formulation or placebo\n\nMeasurements:\n\nBAC: Baseline, 40min, 15min, 30min, 60min, 90min post-drinking Impairment: Baseline, 15min, 30min, 60min post-drinking Hangover: Next morning via text message\n\nSafety Measures:\n\nGRAS ingredients Lab testing of formulations Medical screening Adverse effect questionnaires Pregnancy tests BAC \\<0.08% before leaving\n\nKey Features:\n\nPaired measurements: active vs. placebo for mini-drink and capsule formulations Uber transportation provided Strict inclusion\u002Fexclusion criteria\n\nData Analysis:\n\nElectronic data entry Blinded submission for statistical analysis Paired comparisons and multiple statistical tests\n\nThis study aims to provide robust data on the efficacy in mitigating alcohol's effects, potentially offering a new tool for reducing alcohol-related impairment and hangover symptoms. The design prioritizes safety, consistency, and scientific rigor to ensure reliable results.",[241,30,242,243],"Alcohol Consumption","Hangover Symptoms, NAC","Veisalgia",[80,245,246,247,248,249,250,251,252,253],"blood alcohol","alcohol intoxication","alcohol impairment","BAC","BAC reduction","alcohol half-life","blood alcohol concentration","veisalgia","hangover","2024-12-03",{"date":256,"type":51},"2024-12-09",{"date":258,"type":23},"2024-12-01",{"date":260,"type":23},"2025-02-07",{"name":262,"class":58},"Medical Life Care Planners, LLC",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":17,"sex":18,"minAge":129,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":273,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100571411","phase-1-a-phase-i-study-of-the-interaction-of-alcohol-with-oral-afa-281-in-healthy-volunteers-100571411","NCT06719908","A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers","A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers","Inclusion Criteria:\n\n* Adults between 21 and 55 years of age, inclusive.\n* Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.\n* Body mass index (BMI) within the range of 18.5 to 30.0 kg\u002Fm2, inclusive.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit\n* Adequate venous access\n* Must be surgically sterile (vasectomy, tubal ligation or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm, for 90 days after study drug administration.\n* Agree to abstain from strenuous exercise during the inpatient stay of the study.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug.\n* Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 msec.\n* Has an estimated creatinine clearance (CrCl) outside of normal range.\n* History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n* Requirement for any over-the-counter and\u002For prescription medication, vitamins and\u002For herbal supplements on a regular basis.\n* Use of any medications, vitamins and\u002For herbal supplements within the 2-week period prior to study drug administration.\n* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n* Display any latent signs of alcohol withdrawal per the Clinical Institute Withdrawal of Alcohol Assessment-Revised (CIWA-AR).\n* History or current diagnosis of a substance use disorder.\n* Positive urine drug screen for drugs of abuse at Screening or Day -1.\n* Consumption of alcohol within the 1-day period prior to study drug administration.\n* Receipt of any drug by injection within 30 days prior to study drug administration.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n* History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.\n* Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n* Pregnant or nursing women\n* Receipt of any investigational product within 6 weeks prior to study drug administration.\n* Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration.\n* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.\n* Current enrollment in another clinical study.\n* Previous enrollment in this study.\n* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive AFA-281.","55 Years",{"count":272,"type":23},20,[274],"PHASE1","The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.\n\nParticipants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.",[30,277],"Alcohol Use Disorders",[279,30,280,281],"AFA-281","Ethanol","Healthy Volunteer","2024-12-02",{"date":284,"type":51},"2024-12-06",{"date":286,"type":23},"2025-07-01",{"date":288,"type":23},"2029-09-01",{"name":290,"class":291},"Afasci Inc","INDUSTRY"]