Clinical trial NCT05613608: Alcohol Use Disorder and Cannabidiol
Official title: Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Alcohol Use Disorder
Keywords: alcohol
cannabidiol
cbd
cannabis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-14
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, placebo-controlled, parallel group study.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change in Drinks per Drinking Day
timeFrame: 0-12 weeks
measure: Change in Alcohol Use Disorder
timeFrame: 0-12 weeks
measure: Change in Alcohol Craving
timeFrame: 0-12 Weeks
Secondary outcomes:
measure: Change in Cue-reactivity
timeFrame: 0-12 weeks
measure: Change in Anxiety
timeFrame: 0-12 weeks
measure: Change in Pain Levels
timeFrame: 0-12 weeks
measure: Change in Sleep Disturbance
timeFrame: 0-12 weeks
measure: Change in Impaired Control Scale (ICS)
timeFrame: 0-12 Weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kent Hutchison, PhD
role: PRINCIPAL_INVESTIGATOR
References: