Alcohol Use Disorder
Conditions
Brief summary
The purpose of this study is to determine whether cannabidiol, relative to placebo, affects subjective response to alcohol or alcohol drinking.
Detailed description
This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.
Interventions
DRUGCannabidiol
Cannabidiol oral solution
DRUGPlacebo
Placebo oral solution
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, as assessed by the Structured Clinical Interview for DSM-5 (SCID-5). 2. Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months, with at least 5 standard alcoholic drinks during a drinking episode at least once per week during the past 3 months. 3. Currently not engaged in, and does not want treatment for, alcohol-related problems. 4. Age 21-40. 5. Able to read and understand questionnaires and informed consent. 6. Lives within 50 miles of the study site.
Exclusion criteria
1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder. 2. Any psychoactive substance use (including cannabis, but excluding nicotine) within 30 days prior to screening, as indicated by self-report and urine drug screen. 3. Any cannabidiol use, in any formulation (e.g., oral, topical) within 30 days prior to screening. 4. Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder. 5. Current active suicidal ideation, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). 6. Current use of any psychoactive medication, any medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate), and/or antiepileptic medications (e.g., valproate). 7. Current use of any known hepatotoxic medication. 8. Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used examples not captured by other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average alcohol-induced sedation after medication ingestion | Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication. | Biphasic Alcohol Effects Scale sedation subscale score (range = 0-70; higher scores = greater sedation) |
| Average subjective response to alcohol after medication ingestion | Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication. | Subjective High Assessment Scale score (range = 0-130; higher scores = greater intoxication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol drinking in natural environment | 8 days of medication ingestion. | Total number of standard drinks per day consumed during natural (usual environment) conditions |
Countries
United States
Outcome results
None listed