Alcohol Use Disorder and Cannabidiol

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05613608
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
180
3
49.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a double-blind, placebo-controlled, parallel group study.This is a double-blind, placebo-controlled, parallel group study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2027
Anticipated Study Completion Date :
Apr 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Full-Spectrum Cannabidiol

210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

Drug: Cannabidiol
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.

Active Comparator: Broad-Spectrum Cannabidiol

210mg/day of full-spectrum cannabidiol, containing 0.0% THC.

Drug: Cannabidiol
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.

Placebo Comparator: Placebo

210mg/day of hemp seed oil with no cannabinoids present.

Drug: Placebo
Placebo arm.

Outcome Measures

Primary Outcome Measures

  1. Change in Drinks per Drinking Day [0-12 weeks]

    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.

  2. Change in Alcohol Dependence/Craving [0-12 weeks]

    The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems. HDD and alcohol dependence/craving are the primary behavioral outcomes that will be analyzed.

Secondary Outcome Measures

  1. Change in Cue-reactivity [0-12 weeks]

    Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).

  2. Change in Anxiety [0-12 weeks]

    The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress. Participants rate their anxiety on a scale from 1 (Did not apply to me at all) to 4 (Applied to me very much/most of the time), with higher scores indicating worse outcomes.

  3. Change in Pain Levels [0-12 weeks]

    The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a consists of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of). Participants are also asked to rate the impact of their pain in the last 7 days. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities.

  4. Change in Sleep Disturbance [0-12 weeks]

    The PROMIS Short Form v.1.0 - Sleep Disturbance - 4a will be used to measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Meets one of the following drinking criteria:

  5. 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

  6. 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

  7. Able to attend in-person visits at the study site.

Exclusion Criteria:
  1. Self-reported DSM-V diagnosis of any other substance use disorder.

  2. Current nicotine use.

  3. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.

  4. Daily cannabis use.

  5. Uses CBD products for medical reasons.

  6. Report having and being treated for a serious DSM-V psychiatric disorder, including 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.

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

  8. Currently taking any of the following medications:

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

  10. Acute treatment with any antiepileptic medications.

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

  12. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).

  13. 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.

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

  15. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.

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

  17. Lack of a stable living situation.

  18. Lack of access to internet.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Colorado, Denver
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Kent Hutchison, PhD, University of Colorado - Anschutz Medical Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05613608
Other Study ID Numbers:
  • 22-1894
  • R01AA029606
First Posted:
Nov 14, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023