Cannabidiol for Alcoholism

(CAP Trial)

Overseen By Rachel Baechtold, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare the effects of Full-Spectrum CBD (CBD containing a small amount of THC), Broad-Spectrum CBD (CBD with no THC), and placebo on alcohol consumption and clinically relevant Alcohol Use Disorder (AUD) phenotypes among adults with AUD. The main questions it aims to answer are:

* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce participant alcohol consumption?

* Does Full-Spectrum CBD (fs-CBD), compared to Broad-Spectrum CBD (bs-CBD) and placebo, reduce negative emotionality and other AUD phenotypes?

* What are the effects of fs-CBD and bs-CBD on the gut microbiome and gut permeability?

Researchers will compare fs-CBD to bs-CBD and a placebo (a look-alike substance that contains no CBD or THC) to see if fs-CBD reduces participant alcohol consumption.

Participation will last 12 weeks during which participants will:

* Take the randomly assigned study drug (fs-CBD, bs-CBD, or placebo) daily for 8 weeks and report alcohol use via daily surveys

* Attend 5 in-person study visits

* Check in virtually with study staff weekly during the 8-week medication period

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

Provides informed consent to participate

Willing to provide fecal samples

Willing to have their blood drawn

Exclusion Criteria

Must not be positive for any illicit drugs (besides cannabis) on urine drug screen or self-report any illicit/recreational drug use in the past 30 days

Must not report a history of alcohol-related liver disease or alcohol-related medical illness

Must not be seeking treatment/in treatment for AUD or another substance use disorder

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?

Group I: Full-Spectrum CBD Experimental Treatment 1 Intervention

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).

Group II: Broad- Spectrum CBD Experimental Treatment 1 Intervention

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).

Group III: Placebo Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+