[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05613608":3,"trial-entities:NCT05613608":107,"trial-summary:NCT05613608":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":57,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":80,"locations":83,"central_contacts":98,"overall_officials":101,"references":105,"see_also_links":106},"NCT05613608","22-1894","Alcohol Use Disorder and Cannabidiol","Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies","RECRUITING","2027-04","2026-06","2026-06-15","2023-04-30","University of Colorado, Denver","OTHER",false,"This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.","To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.\n\nThis is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks. The current study will test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects.",[19],"Alcohol Use Disorder",[21,22,23,24],"alcohol","cannabidiol","cbd","cannabis","INTERVENTIONAL","TREATMENT",[28,29],"PHASE2","PHASE3",{"count":31,"type":32},180,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Cannabidiol","The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.",[39,40],"Broad-Spectrum Cannabidiol","Full-Spectrum Cannabidiol",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Placebo","Placebo arm.",[42],[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Change in Drinks per Drinking Day","The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.","0-12 weeks",{"measure":51,"description":52,"timeFrame":49},"Change in Alcohol Use Disorder","The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems.",{"measure":54,"description":55,"timeFrame":56},"Change in Alcohol Craving","The Penn Alcohol Craving Scale (PACS) will be used to assess changes in alcohol craving.","0-12 Weeks",[58,61,64,67,70],{"measure":59,"description":60,"timeFrame":49},"Change in Cue-reactivity","Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).",{"measure":62,"description":63,"timeFrame":49},"Change in Anxiety","The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension\u002Fstress. Participants rate their anxiety on a scale from 1 (Did not apply to me at all) to 4 (Applied to me very much\u002Fmost of the time), with higher scores indicating worse outcomes.",{"measure":65,"description":66,"timeFrame":49},"Change in Pain Levels","The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a consists of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of). Participants are also asked to rate the impact of their pain in the last 7 days. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities.",{"measure":68,"description":69,"timeFrame":49},"Change in Sleep Disturbance","The PROMIS Short Form v.1.0 - Sleep Disturbance - 4a will be used to measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction.",{"measure":71,"description":72,"timeFrame":56},"Change in Impaired Control Scale (ICS)","The Impaired Control Scale will assess impulsivity, awareness of compulsion to drink, and control over drinking behavior.","ALL","21 Years",null,{"inclusion":77,"exclusion":78,"raw_text":79},[],[],"Inclusion Criteria:\n\n1. Must be ≥21 years old.\n2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).\n3. Expresses desire to reduce or quit drinking.\n4. If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening, or if a male respondent reports consuming 5 or more alcoholic drinks on at least one drinking day per week on average (4 or more if female).\n5. Able to attend in-person visits at the study site.\n6. Participants reporting current nicotine use in any form will be included.\n\nExclusion Criteria:\n\n1. Self-reported DSM-V diagnosis of any other substance use disorder.\n2. Self-report illicit\u002Frecreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.\n3. Uses CBD products for medical reasons.\n4. Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive\u002Fcompulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.\n5. Endorsing item 2 on the C-SSRS measure of suicide risk.\n6. Currently taking any of the following medications:\n\n   1. Those known to have a major interaction with Epidiolex.\n   2. Acute treatment with any antiepileptic medications.\n   3. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and\u002For topiramate).\n7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).\n8. Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.\n9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.\n10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.\n11. Current charges pending for a violent crime (not including DUI-related offenses).\n12. Lack of a stable living situation.\n13. Lack of access to internet.",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":95},"University of Colorado Anschutz","Aurora","Colorado","80045","United States",[91],{"name":92,"role":93,"email":94},"Raeghan Mueller, PhD","CONTACT","raeghan.mueller@cuanschutz.edu",{"lat":96,"lon":97},39.72943,-104.83192,[99],{"name":92,"role":93,"phone":100,"email":94},"3037242210",[102],{"name":103,"affiliation":13,"role":104},"Kent Hutchison, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Alcohol use disorder",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a double-blind, placebo-controlled study, meaning neither you nor the researchers will know if you are receiving CBD or the placebo. About 180 participants will be randomly assigned to one of the treatment groups.","completed","Cannabidiol for Alcohol Use Disorder","This study is looking at how Cannabidiol (CBD), a compound from the cannabis plant, might help people with Alcohol Use Disorder (AUD). Researchers want to see if taking a moderate dose of CBD, either full spectrum (with a tiny bit of THC) or broad spectrum (no THC), can reduce drinking, cravings for alcohol, and anxiety. You could join if you are at least 21 years old, have moderate AUD, and want to drink less. The study will compare CBD to a placebo (a pill with no active medicine) over 12 weeks to see if it helps reduce your alcohol use and cravings.","The main changes in drinking, alcohol use disorder, and craving will be measured over 12 weeks.",102,"If you are eligible, you will receive one of the study conditions for 12 weeks. The study will measure changes in your drinking, alcohol craving, and alcohol use disorder during this time.","Not stated in the trial record.",[36,42],"v2"]