Phase II Study of Cannabidiol as an Add-On Treatment During Inpatient Alcohol Detoxification for Severe Alcohol Use Disorder

What this Trial Is About

Researchers are evaluating cannabidiol as an additional treatment during inpatient alcohol detoxification for patients with severe alcohol use disorder. This phase II randomized clinical trial aims to improve the rate of continuous abstinence at 6 weeks, which is one month after discharge from a scheduled hospital stay for alcohol withdrawal. The study also assesses safety, alcohol use reduction in case of relapse, withdrawal symptoms, anxiety, and cannabis use in patients who also use cannabis. Participants will be randomly assigned to one of three groups receiving oxazepam plus either placebo, 450 mg cannabidiol, or 900 mg cannabidiol daily for 11 days during their inpatient stay. After discharge, all groups will have follow-up visits once a week for 4 weeks to monitor abstinence and other outcomes. Blood and urine tests will be used to measure cannabidiol levels and confirm abstinence, alongside self-reported alcohol use and symptoms. During the study, participants will report daily alcohol use and symptoms from day 0 to day 10 and then weekly after discharge up to week 6. Clinical examinations and urine tests for alcohol metabolites will confirm abstinence. Researchers will also monitor side effects, withdrawal severity, anxiety, craving, sleep quality, and cannabis use. The total study duration for participants is about 6 weeks including inpatient treatment and outpatient follow-up visits.

Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation : CBD-OH