Status:
COMPLETED
CBD for the Treatment of Alcohol Use Disorder
Lead Sponsor:
University of Colorado, Denver
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (CBD) and broad spectrum CBD, compared to a placebo control (PC), to reduc...
Detailed Description
The current study will directly test the hypothesis that a moderate dose of cannabidiol (CBD) leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxi...
Eligibility Criteria
Inclusion
- Must be between 21-60 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Currently seeking treatment for AUD.
- If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening.
- Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening.
- Live within 35 miles of the study site.
Exclusion
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Use nicotine daily.
- Self-report use of cocaine, amphetamines, opioids, cannabis, or benzodiazepines in the last 30 days.
- Report having or being treated for a current DSM-V 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.
- Endorsing an item on the RMTS-S measure of suicide risk.
- Currently taking any of the following medications:
- Those known to have a major interaction with Epidiolex.
- Acute treatment with any antiepileptic medications.
- Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
- Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04873453
Start Date
August 30 2021
End Date
May 31 2023
Last Update
October 1 2024
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045