Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
NCT Number: NCT06512389
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol Use Disorder
Interventions: DRUG: Oral solution
Sponsor: Centre for Addiction and Mental Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2026-12-31
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, M6J 1H4, Canada

Summary:
This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

Primary Outcome Measures: Total number of drinks administered during the alcohol-self administration session, Number of drinks consumed during the alcohol self-administration session., 2 hours|Peak breath alcohol concentration during the alcohol-self administration session, Maximum breath alcohol concentration during the alcohol self-administration session., 2 hours|Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session., Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving), Baseline|Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session., Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving), 20 min after priming dose
Secondary Outcome Measures: Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire., Drug Effects Questionnaire (each item scored from 0 to 100). The higher the score, the more the participant feels that "effect"., 3 hours|Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale, Brief Biphasic Alcohol Effects Scale (stimulation factor ranges from 0-30, sedation factor ranges from 0-30), 3 hours|Safety and tolerability of CBD, Measured through monitoring adverse effects during the study, measured by number of adverse effects and severity of adverse effect., Approximately 5 weeks|Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo, Number of drinks, drinking days and binge drinking (≥ 4 drinks during a single day for females, ≥ 5 drinks during a single day for males), 10 days|Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo, Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving), 7 days|Differences in self-reported anxiety (measured by modified Generalized Anxiety Disorder-7) outside of the lab during treatment with CBD vs. placebo, Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety), 7 days