Using CBD to help reduce alcohol consumption in people with alcohol use disorder

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

This study is testing whether CBD can help people with alcohol use disorder drink less and feel better over 12 weeks.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05613608 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, placebo-controlled study that aims to evaluate the effectiveness of full spectrum and broad spectrum cannabidiol (CBD) in reducing alcohol consumption among individuals diagnosed with moderate alcohol use disorder. Participants will be randomly assigned to receive either CBD or a placebo for a duration of 12 weeks. The study will assess various outcomes, including changes in drinking behavior, alcohol cravings, inflammation markers, anxiety levels, and sleep quality. The trial also seeks to determine the safety and tolerability of CBD, particularly the effects of the small amount of THC present in full spectrum CBD.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older who meet the criteria for moderate alcohol use disorder and wish to reduce or quit drinking.

Not a fit: Patients with other substance use disorders or serious psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment option for individuals struggling with alcohol use disorder.

How similar studies have performed: While there is emerging interest in the use of CBD for various conditions, this specific approach to treating alcohol use disorder with CBD is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Must be ≥21 years old.
2. 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).
3. Expresses desire to reduce or quit drinking.
4. If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening.
5. Able to attend in-person visits at the study site.
6. Participants reporting current nicotine use in any form will be included.

Exclusion Criteria:

1. Self-reported DSM-V diagnosis of any other substance use disorder.
2. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
3. Daily cannabis use.
4. Uses CBD products for medical reasons.
5. Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.
6. Endorsing item 2 on the C-SSRS measure of suicide risk.
7. Currently taking any of the following medications:

   1. Those known to have a major interaction with Epidiolex.
   2. Acute treatment with any antiepileptic medications.
   3. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
8. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
9. Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.
10. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
11. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
12. Current charges pending for a violent crime (not including DUI-related offenses).
13. Lack of a stable living situation.
14. Lack of access to internet.

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Kent Hutchison, PhD — University of Colorado, Denver
• Study coordinator: Raeghan Mueller, PhD

Conditions Alcohol Use Disorder; alcohol; cannabidiol; cbd; cannabis