Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | 10-day supply of 600 mg of CBD, taken orally twice daily |
|
| Placebo | Placebo Comparator | 10-day supply of 600 mg of placebo, taken orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral solution | Drug | 300 mg taken morning and evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Xiao, MSc | Contact | 416-535-8501 | 32447 | kelly.xiao@camh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Sloan, MD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Recruiting | Toronto | Ontario | M6J 1H4 | Canada |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Within-subject randomized double-blind placebo controlled crossover trial
Not provided
Not provided
Not provided
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 |
| D004327 | Drinking Behavior |
| D001519 | Behavior |