Alcohol Use Disorder and Cannabidiol

Official title

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

Overview

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.

Interventions

• 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.
• Drug Placebo
  Placebo arm.

Primary outcome measures

• Change in Drinks per Drinking Day [Time frame: 0-12 weeks]
• Change in Alcohol Use Disorder [Time frame: 0-12 weeks]
• Change in Alcohol Craving [Time frame: 0-12 Weeks]

Secondary outcome measures (5)

• Change in Cue-reactivity [Time frame: 0-12 weeks]
• Change in Anxiety [Time frame: 0-12 weeks]
• Change in Pain Levels [Time frame: 0-12 weeks]
• Change in Sleep Disturbance [Time frame: 0-12 weeks]
• Change in Impaired Control Scale (ICS) [Time frame: 0-12 Weeks]

Eligibility criteria

Inclusion criteria

• Must be ≥21 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).
• Expresses desire to reduce or quit drinking.
• 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, or if a male respondent reports consuming 5 or more alcoholic drinks on at least one drinking day per week on average (4 or more if female).
• Able to attend in-person visits at the study site.
• Participants reporting current nicotine use in any form will be included.

Exclusion criteria

• Self-reported DSM-V diagnosis of any other substance use disorder.
• Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
• Uses CBD products for medical reasons.
• 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.
• Endorsing item 2 on the C-SSRS 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 in the last six months, 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.
• Lack of access to internet.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Colorado Anschutz — Aurora

Identifiers

NCT: NCT05613608 · 22-1894 · R01AA029606

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗