INTERVENTIONALRECRUITINGNCT05613608

Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-15

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2, PHASE3
Enrollment: 180 (ESTIMATED)
Start date: 2023-04-30
Sponsor: University of Colorado, Denver
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Alcoholism

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

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.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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, 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). 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. Uses CBD products for medical reasons. 4. 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. 5. Endorsing item 2 on the C-SSRS measure of suicide risk. 6. 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). 7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens). 8. 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. 9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer. 10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. 11. Current charges pending for a violent crime (not including DUI-related offenses). 12. Lack of a stable living situation. 13. Lack of access to internet.

primary outcomes

primary measures

Change in Drinks per Drinking Day

Time frame: 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.

Change in Alcohol Use Disorder

Time frame: 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.

Change in Alcohol Craving

Time frame: 0-12 Weeks

The Penn Alcohol Craving Scale (PACS) will be used to assess changes in alcohol craving.

secondary outcomes

secondary measures

Change in Cue-reactivity

Time frame: 0-12 weeks

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

Change in Anxiety

Time frame: 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.

Change in Pain Levels

Time frame: 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.

Change in Sleep Disturbance

Time frame: 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.

Change in Impaired Control Scale (ICS)

Time frame: 0-12 Weeks

The Impaired Control Scale will assess impulsivity, awareness of compulsion to drink, and control over drinking behavior.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 60087e3c-45c3-4cac-9bff-a02e4d16ff6f
Retrieved: 11/09/2026, 14:16:52
SHA-256: 29e0aad7c382e202de4c15dbef20162f9d18191138ab6911a4cc9b4771821c13