Alcohol Use Disorder and Cannabidiol

Last updated: September 27, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

2/3

Condition

Alcohol Dependence

Substance Abuse

Alcohol Use Disorder

Treatment

Placebo

Cannabidiol

Clinical Study ID

NCT05613608
22-1894
R01AA029606
  • Ages > 21
  • All Genders

Study Summary

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

Eligibility Criteria

Inclusion

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 perweek prior to screening; if female, reports drinking, on average, at least 10standard 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

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, includingpanic disorder, obsessive/compulsive disorder, post-traumatic stress disorder,bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any otherpsychotic mental disorder.

  6. Endorsing item 2 on the C-SSRS measure of suicide risk.

  7. Currently taking any of the following medications:

  8. Those known to have a major interaction with Epidiolex.

  9. Acute treatment with any antiepileptic medications.

  10. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone,acamprosate, and/or topiramate).

  11. Self-reported history of severe alcohol withdrawal (e.g., seizure, deliriumtremens).

  12. Clinically significant medical problems in the last six months, such ascardiovascular, renal, gastrointestinal, or endocrine problems, that would impairparticipation or limit medication ingestion.

  13. Current or past alcohol-related medical illness, such as gastrointestinal bleeding,pancreatitis, hepatocellular disease, or peptic ulcer.

  14. Females of childbearing potential who are pregnant, nursing, or who are not using areliable form of birth control.

  15. Current charges pending for a violent crime (not including DUI-related offenses).

  16. Lack of a stable living situation.

  17. Lack of access to internet.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
April 30, 2023
Estimated Completion Date:
April 30, 2027

Study Description

To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, 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 12 weeks. The current study will test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects.

Connect with a study center

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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