[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614435":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":48,"studyPopulation":39,"armGroups":49,"interventions":67,"overallOfficials":87,"centralContacts":92,"locations":101,"responsibleParty":119,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":39,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":103,"whyStopped":39,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":25},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Alcohol Self-Administration During the Bar Lab Task","Number of drinks (between 0-8) subjects choose to self-administer during the Bar Lab Alcohol Self-Administration Task at the week 8 study visit.","Week 8",{"measure":14,"description":15,"timeFrame":16},"Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day)","Drinks Per Drinking Day (DPDD) during the 12-week study period as reported on Timeline Follow Back at Baseline (prior to treatment), Week 4, Week 8, and Week 12.","Baseline, Week 4, Week 8, and Week 12",{"measure":18,"description":19,"timeFrame":16},"Change in Phosphatidylethanol (PEth)","Phosphatidylethanol (PEth) concentration in blood samples collected at Baseline (prior to treatment), Week 4, Week 8, and Week 12.",[21],{"measure":22,"description":23,"timeFrame":24},"Change in Negative Emotionality ANA Domain Score","This summary score will be calculated for change from baseline to follow-up for each of the four ANA Negative Emotionality Measures (Beck Depression Inventory-II, Beck Anxiety Inventory, State-Trait Anxiety Inventory and Drinker Inventory of Consequences-2R) . We will first subtract baseline raw scores from follow-up raw scores for each measure. The summary score will be comprised of the average of the standardized Z scores of the change scores created for each of the four measures. Z scores will range from -3 to 3 after adjusting for outliers, with higher average Z scores indicating a worse outcome.","Baseline, Week 8",[26,29,33],{"measure":27,"description":28,"timeFrame":24},"Change in Gut Microbial Diversity","Gut microbial diversity from fecal samples collected at Baseline (prior to treatment) and Week 8.",{"measure":30,"description":31,"timeFrame":32},"Change in Gut Permeability (Lipopolysaccharide Binding Protein [LBP])","Lipopolysaccharide Binding Protein levels in blood samples collected at Baseline (prior to treatment) and Week 8.","Baseline, 8 Weeks",{"measure":34,"description":35,"timeFrame":32},"Change in Gut Permeability (CD14)","CD14 levels in blood samples collected at Baseline (prior to treatment) and Week 8.",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":39,"timePerspective":39,"maskingInfo":41},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":42,"maskingDescription":39,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Your participation will include up to five in-person visits over about 13 weeks, including a screening visit, a visit to get your medication, a midpoint visit, an experimental lab session, and a final follow-up visit. You will be assigned to a study medication which you will take daily for 8 weeks while completing daily surveys and weekly virtual check-ins with the research team. During the experimental lab session visit, you will be offered alcohol to drink at the bar lab.",[50,56,61],{"label":51,"type":52,"description":53,"interventionNames":54},"Full-Spectrum CBD","EXPERIMENTAL","Subjects will take 200 mg of full-spectrum CBD (\\[fsCBD\\] CBD that contains \\\u003C0.3% THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the fsCBD condition will take approximately 100mg fsCBD in the morning (2 capsules) and 100mg fsCBD in the evening (2 capsules).",[55],"Drug: Full-Spectrum Cannabidiol (CBD)",{"label":57,"type":52,"description":58,"interventionNames":59},"Broad- Spectrum CBD","Subjects will take 200 mg of broad-spectrum CBD (\\[bsCBD\\] CBD that contains no THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the bsCBD condition will take approximately 100mg bsCBD in the morning (2 capsules) and 100mg bsCBD in the evening (2 capsules).",[60],"Drug: Broad-Spectrum Cannabidiol (CBD)",{"label":62,"type":63,"description":64,"interventionNames":65},"Placebo","PLACEBO_COMPARATOR","Subjects will take a matching placebo solution (100% Hemp Seed Oil) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the condition will take approximately 100mg hemp seed oil in the morning (2 capsules) and 100mg hemp seed oil in the evening (2 capsules).",[66],"Drug: Placebo",[68,76,82],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","Full-Spectrum Cannabidiol (CBD)","Dose: Approximately 200mg of full-spectrum CBD (\\\u003C0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.",[51],[74,75],"Hemp-derived, full-spectrum cannabidiol","Ecofibre USA\u002FAnanda Hemp",{"type":69,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Broad-Spectrum Cannabidiol (CBD)","Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.",[57],[81,75],"Hemp-derived, broad-spectrum cannabidiol",{"type":69,"name":62,"description":83,"armGroupLabels":84,"otherNames":85},"Active Ingredients: N\u002FA Other Ingredients: Hemp seed oil, glycerin, gelatine.",[62],[86,75],"100% Hemp Seed Oil",[88],{"name":89,"affiliation":90,"role":91},"Hollis C Karoly, PhD","University of Colorado School of Medicine- Anschutz Medical Campus","PRINCIPAL_INVESTIGATOR",[93,97],{"name":89,"role":94,"phone":95,"phoneExt":39,"email":96},"CONTACT","303-724-7179","hollis.karoly@cuanschutz.edu",{"name":98,"role":94,"phone":99,"phoneExt":39,"email":100},"Landon Tomb, M.S.","225-244-3429","landon.tomb@cuanschutz.edu",[102],{"facility":90,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"RECRUITING","Aurora","Colorado","80045","United States","US",{"type":110,"coordinates":111},"Point",[112,113],-104.83192,39.72943,{"lat":113,"lon":112},[116,117],{"name":89,"role":94,"phone":95,"phoneExt":39,"email":96},{"name":118,"role":94,"phone":99,"phoneExt":39,"email":100},"Landon C Tomb, MS",{"type":120,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[122],{"name":123,"class":124},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100614435","phase-2-cannabidiol-and-alcohol-use-disorder-phenotypes-100614435",false,"NCT07279558","Cannabidiol and Alcohol Use Disorder Phenotypes","Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine","CAP","Inclusion Criteria:\n\n1. Age 21-65\n2. Have used CBD and cannabis at least once in the last year\n3. Regularly drink alcohol\n4. Able to provide informed consent and attend in-person study visits\n\nExclusion Criteria:\n\n1. Current use of medications known to have major interaction with Epidiolex, Marinol, or alcohol\n2. Current use of antiepileptic medication or any psychotropic medication besides antidepressants\n3. Pregnant, nursing, or planning a pregnancy\n4. Medical conditions that contraindicates the use of CBD or alcohol\n5. Current medical conditions that may require intensive care during the study period\n\nNot everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.","ALL","21 Years","65 Years",{"count":137,"type":138},150,"ESTIMATED","INTERVENTIONAL",[141],"PHASE2","The goal of this study is to learn how CBD affects drinking in people who drink alcohol regularly. Researchers want to see if CBD can help people drink less and reduce problems related to alcohol use.",[144],"Alcohol Use Disorder",[146,147],"Alcohol","Cannabidiol","2026-09-15",{"date":150,"type":151},"2026-09-16","ACTUAL",{"date":153,"type":151},"2026-04-21",{"date":155,"type":138},"2029-08-31",{"name":5,"class":6},1]