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Researchers are evaluating the use of cannabidiol (CBD) as an add-on treatment during inpatient alcohol detoxification to help improve abstinence in patients with severe alcohol use disorder. This phase II, double-blind, randomized clinical trial aims to increase the rate of continuous abstinence at week 6 of the study, which is one month after discharge from the scheduled alcohol withdrawal inpatient stay. The study also assesses safety, reduction in alcohol use in case of relapse, withdrawal symptoms, anxiety symptoms, and cannabis use among patients who also use cannabis. Participants are randomized into three groups, each receiving oxazepam plus either a placebo, 450 mg of cannabidiol per day, or 900 mg of cannabidiol per day for 11 days during their inpatient stay. The inpatient stay typically lasts between 11 and 17 days. After discharge, all groups have weekly follow-up visits for up to six weeks to monitor if abstinence is maintained. In addition, a subgroup of patients will have blood tests to measure CBD levels and cannabinoid analysis if they are cannabis users. During the study, patients complete daily and weekly assessments including self-reported alcohol use using standardized timeline follow-back scales, withdrawal and craving scales, anxiety scales, sleep quality questionnaires, and side effect checklists. Urinary tests for alcohol metabolites and cannabinoids are performed multiple times during inpatient stay and follow-up. Researchers monitor clinical signs of intoxication and record any relapses or changes in substance use. The total duration of participation extends up to six weeks after discharge from inpatient care.

Age: 18Years - 75YearsAll GendersPhase 2
12 locations
Sevran Clinical Trials | DecenTrialz