CBD for the Treatment of Alcohol Use Disorder

NCT04873453 | Completed Phase 2 FDA Drug

• 1 other identifier: 20-2694
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

Conditions

Alcohol Use Disorder

Keywords

Alcohol; Cannabidiol; CBD; Cannabis

Outcome Measures

Primary Outcomes (8)

• Drinks per Drinking Day

  The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.

  0-8 weeks

• Drinks per Drinking Day

  The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.

  0-16 weeks

• Drinks per Drinking Day

  The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.

  0-4 weeks

• Drinks per Drinking Day

  The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.

  4-8 weeks

• Alcohol Dependence/Craving

  The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.

  0-16 weeks

• Alcohol Dependence/Craving

  The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.

  4-8 weeks

• Alcohol Dependence/Craving

  The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.

  0-8 weeks

• Alcohol Dependence/Craving

  The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.

  0-4 weeks

Secondary Outcomes (15)

• Cue-reactivity

  0-4 weeks

• Cue-reactivity

  4-8 weeks

• Cue-reactivity

  0-8 weeks

• Anxiety

  0-4 weeks

• Anxiety

  4-8 weeks

Study Arms (3)

Full-spectrum Cannabidiol

ACTIVE COMPARATOR

150mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.

Drug: Cannabidiol

Broad-spectrum Cannabidiol

EXPERIMENTAL

150mg/day of broad-spectrum cannabidiol, containing 0%THC.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

150mg/day of hemp-seed oil with no cannabinoids present.

Drug: Placebo

Interventions

Cannabidiol DRUG

The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.

Also known as: CBD

Broad-spectrum Cannabidiol; Full-spectrum Cannabidiol

Placebo DRUG

Placebo arm

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Mueller RL, Hooper JF, Ellingson JM, Olsavsky AK, Rzasa-Lynn R, Bryan AD, Bidwell LC, Hutchison KE. A preliminary randomized trial of the safety, tolerability, and clinical effects of hemp-derived cannabidiol in alcohol use disorder. Front Psychiatry. 2025 Apr 28;16:1516351. doi: 10.3389/fpsyt.2025.1516351. eCollection 2025.

  PMID: 40357520 DERIVED

MeSH Terms

Conditions

Alcoholism; Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, placebo-controlled, parallel group study.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 5, 2021
• Study Start: August 30, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)