Cannabidiol for Alcoholism
(CAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Full-Spectrum CBD (which includes a small amount of THC) or Broad-Spectrum CBD (no THC) can help reduce alcohol consumption and improve mood in individuals with Alcohol Use Disorder (AUD). Participants will be randomly assigned to take either Full-Spectrum CBD, Broad-Spectrum CBD, or a placebo daily for 8 weeks. Researchers will also examine how these treatments affect the gut. This trial suits adults diagnosed with moderate or severe AUD, who consume at least 20 drinks a week, and have at least one heavy drinking day per week. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
You may need to stop taking certain medications to participate in this trial. Specifically, you cannot take medications that interact with Epidiolex or Marinol, certain antiepileptic or psychotropic medications, or medications that affect alcohol intake. If you're on antidepressants, you must be on a stable dose for the past 90 days.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Full-Spectrum CBD (fs-CBD) and Broad-Spectrum CBD (bs-CBD) are generally safe. Earlier studies found that participants tolerated both types well, with side effects usually mild and less serious than those from other addiction treatments. No major safety differences appeared between the two types of CBD.
However, using CBD with alcohol or certain drugs might not be safe. Report any side effects to your healthcare provider. Overall, research suggests that CBD treatments are promising and safe for use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a new approach to tackling alcoholism by using cannabidiol (CBD). Unlike traditional treatments that often focus on behavioral therapies or medications like disulfiram and naltrexone, CBD works by potentially interacting with the brain's endocannabinoid system, which might help reduce cravings and anxiety associated with alcohol use. Full-spectrum CBD includes a tiny amount of THC, which might enhance its therapeutic effects, while broad-spectrum CBD excludes THC entirely, offering a non-psychoactive alternative. This dual approach provides a promising new avenue for individuals looking for alternatives to conventional alcoholism treatments.
What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?
This trial will compare the effects of full-spectrum CBD (fs-CBD) and broad-spectrum CBD (bs-CBD) on alcohol consumption and cravings. Research has shown that both fs-CBD and bs-CBD may help reduce the urge to drink alcohol and lower overall alcohol consumption. One study found that fs-CBD was more effective than bs-CBD in reducing alcohol cravings and symptoms of Alcohol Use Disorder (AUD). Other research indicates that CBD can decrease how often people drink and their desire to consume alcohol. CBD might work by altering how the brain reacts to stress and triggers related to alcohol. Both types of CBD may help by calming the brain's response to alcohol and making it less appealing.25678
Who Is on the Research Team?
Hollis C Karoly, PhD
Principal Investigator
University of Colorado School of Medicine- Anschutz Medical Campus
Are You a Good Fit for This Trial?
This trial is for adults with Alcohol Use Disorder (AUD) who may also experience alcohol-related intimate partner violence. Participants will be involved in the study for 12 weeks, taking a daily dose of either Full-Spectrum CBD, Broad-Spectrum CBD, or placebo and reporting their alcohol use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take the assigned study drug (fs-CBD, bs-CBD, or placebo) daily for 8 weeks, report alcohol use via daily surveys, and attend 5 in-person study visits with weekly virtual check-ins.
Follow-up
Participants are monitored for changes in alcohol consumption and AUD phenotypes, with assessments at baseline, week 4, week 8, and week 12.
What Are the Treatments Tested in This Trial?
Interventions
- Broad-Spectrum Cannabidiol (CBD)
- Full-Spectrum Cannabidiol (CBD)
Trial Overview
The study tests if Full-Spectrum CBD (with a bit of THC) or Broad-Spectrum CBD (no THC) can reduce alcohol consumption and improve emotional states compared to a placebo. It also examines the effects on gut health over an 8-week period with regular check-ins and five in-person visits.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Subjects will take 200 mg of full-spectrum CBD (\[fsCBD\] CBD that contains \<0.3% THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the fsCBD condition will take approximately 100mg fsCBD in the morning (2 capsules) and 100mg fsCBD in the evening (2 capsules).
Subjects will take 200 mg of broad-spectrum CBD (\[bsCBD\] CBD that contains no THC) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the bsCBD condition will take approximately 100mg bsCBD in the morning (2 capsules) and 100mg bsCBD in the evening (2 capsules).
Subjects will take a matching placebo solution (100% Hemp Seed Oil) daily for 8 weeks. The total dose is split into a morning and evening dose, such that participants in the condition will take approximately 100mg hemp seed oil in the morning (2 capsules) and 100mg hemp seed oil in the evening (2 capsules).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Citations
CBD for the Treatment of Alcohol Use Disorder
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 ...
A preliminary randomized trial of the safety, tolerability, and ...
For example, CBD reduces the reinforcing properties of alcohol and decreases alcohol consumption frequency and drinking motivation (18, 19). CBD ...
Study protocol for a double-blind, randomised, cross over ...
CBD could reduce alcohol craving and seeking due to moderating responses to alcohol and stress cues, normalising dysregulated neurobiological systems and/or ...
Cannabidiol mitigates alcohol dependence and withdrawal ...
This study investigated the effects of chronic CBD administration on alcohol dependence, withdrawal symptoms, and neurodegeneration using two complementary ...
NCT05613608 | Alcohol Use Disorder and 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 ...
A preliminary randomized trial of the safety, tolerability, and ...
In this pilot study, safety profiles fsCBD and bsCBD were similar, and fsCBD was associated with a greater reduction in craving and AUD ...
A preliminary randomized trial of the safety, tolerability, and ...
In this pilot study, safety profiles fsCBD and bsCBD were similar, and fsCBD was associated with a greater reduction in craving and AUD symptoms relative to ...
Cannabidiol (CBD) – Potential Harms, Side Effects, and ...
Do not use CBD concurrently with medications, alcohol, or illicit drugs. ○ If you experience adverse events as a result of using CBD products, report them to ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.