Alcohol Use Disorder and Cannabidiol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. Meets one of the following drinking criteria: 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 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 Able to attend in-person visits at the study site. Exclusion Criteria: Self-reported DSM-V diagnosis of any other substance use disorder. Current nicotine use. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days. Daily cannabis use. Uses CBD products for medical reasons. 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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blind, placebo-controlled, parallel group study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full-Spectrum Cannabidiol<br>210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC. | Drug: Cannabidiol<br>* 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.<br>|
| Active Comparator: Broad-Spectrum Cannabidiol<br>210mg/day of full-spectrum cannabidiol, containing 0.0% THC. | Drug: Cannabidiol<br>* 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.<br>|
| Placebo Comparator: Placebo<br>210mg/day of hemp seed oil with no cannabinoids present. | Drug: Placebo<br>* Placebo arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Drinks per Drinking Day | 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. | 0-12 weeks | 
| Change in Alcohol Dependence/Craving | 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. | 0-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cue-reactivity | Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006). | 0-12 weeks | 
| Change in Anxiety | 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. | 0-12 weeks | 
| Change in Pain Levels | 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. | 0-12 weeks | 
| Change in Sleep Disturbance | 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. | 0-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, cannabidiol, cbd, cannabis