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.
Participants with alcohol use disorder will receive treatment daily (600mg cannabidiol or placebo), each for 10 consecutive days, with a 2-week long washout period between treatments. Participants will be randomized to receive placebo or cannabidiol first (in blocks of random size) so that equal number of participants are allocated to each sequence. Around day 8 of each treatment period, participants will complete an alcohol self-administration session in the laboratory to assess the effects of treatment on alcohol consumption and alcohol-related craving.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
300 mg taken morning and evening
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
RECRUITINGTotal number of drinks administered during the alcohol-self administration session
Number of drinks consumed during the alcohol self-administration session.
Time frame: 2 hours
Peak breath alcohol concentration during the alcohol-self administration session
Maximum breath alcohol concentration during the alcohol self-administration session.
Time frame: 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)
Time frame: 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)
Time frame: 20 min after priming dose
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".
Time frame: 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)
Time frame: 3 hours
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Safety and tolerability of CBD
Measured through monitoring adverse effects during the study, measured by number of adverse effects and severity of adverse effect.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 7 days