Cannabidiol and Alcohol Use Disorder Phenotypes (CAP)

March 30, 2026 updated by: University of Colorado, Denver

Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine

The goal of this study is to learn how CBD affects drinking in people who drink alcohol regularly. Researchers want to see if CBD can help people drink less and reduce problems related to alcohol use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Your participation will include up to five in-person visits over about 13 weeks, including a screening visit, a visit to get your medication, a midpoint visit, an experimental lab session, and a final follow-up visit. You will be assigned to a study medication which you will take daily for 8 weeks while completing daily surveys and weekly virtual check-ins with the research team. During the experimental lab session visit, you will be offered alcohol to drink at the bar lab.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 21-65
  2. Have used CBD and cannabis at least once in the last year
  3. Regularly drink alcohol
  4. Able to provide informed consent and attend in-person study visits

Exclusion Criteria:

  1. Current use of medications known to have major interaction with Epidiolex, Marinol, or alcohol
  2. Current use of antiepileptic medication or any psychotropic medication besides antidepressants
  3. Pregnant, nursing, or planning a pregnancy
  4. Medical conditions that contraindicates the use of CBD or alcohol
  5. Current medical conditions that may require intensive care during the study period

Not everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full-Spectrum CBD
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).
Drug: Full-Spectrum Cannabidiol (CBD)
Dose: Approximately 200mg of full-spectrum CBD (<0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Other Names:
  • Hemp-derived, full-spectrum cannabidiol
  • Ecofibre USA/Ananda Hemp
Experimental: Broad- Spectrum CBD
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).
Drug: Broad-Spectrum Cannabidiol (CBD)
Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Other Names:
  • Ecofibre USA/Ananda Hemp
  • Hemp-derived, broad-spectrum cannabidiol
Placebo Comparator: Placebo
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).
Drug: Placebo
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
Other Names:
  • Ecofibre USA/Ananda Hemp
  • 100% Hemp Seed Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Self-Administration During the Bar Lab Task
Time Frame: Week 8
Number of drinks (between 0-8) subjects choose to self-administer during the Bar Lab Alcohol Self-Administration Task at the week 8 study visit.
Week 8
Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day)
Time Frame: Baseline, Week 4, Week 8, and Week 12
Drinks Per Drinking Day (DPDD) during the 12-week study period as reported on Timeline Follow Back at Baseline (prior to treatment), Week 4, Week 8, and Week 12.
Baseline, Week 4, Week 8, and Week 12
Change in Phosphatidylethanol (PEth)
Time Frame: Baseline, Week 4, Week 8, and Week 12
Phosphatidylethanol (PEth) concentration in blood samples collected at Baseline (prior to treatment), Week 4, Week 8, and Week 12.
Baseline, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Negative Emotionality ANA Domain Score
Time Frame: Baseline, Week 8
This summary score will be calculated for change from baseline to follow-up for each of the four ANA Negative Emotionality Measures (Beck Depression Inventory-II, Beck Anxiety Inventory, State-Trait Anxiety Inventory and Drinker Inventory of Consequences-2R) . We will first subtract baseline raw scores from follow-up raw scores for each measure. The summary score will be comprised of the average of the standardized Z scores of the change scores created for each of the four measures. Z scores will range from -3 to 3 after adjusting for outliers, with higher average Z scores indicating a worse outcome.
Baseline, Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gut Microbial Diversity
Time Frame: Baseline, Week 8
Gut microbial diversity from fecal samples collected at Baseline (prior to treatment) and Week 8.
Baseline, Week 8
Change in Gut Permeability (Lipopolysaccharide Binding Protein [LBP])
Time Frame: Baseline, 8 Weeks
Lipopolysaccharide Binding Protein levels in blood samples collected at Baseline (prior to treatment) and Week 8.
Baseline, 8 Weeks
Change in Gut Permeability (CD14)
Time Frame: Baseline, 8 Weeks
CD14 levels in blood samples collected at Baseline (prior to treatment) and Week 8.
Baseline, 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Hollis C Karoly, PhD, University of Colorado School of Medicine- Anschutz Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1612
  • R01AA031664 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will submit all de-identified individual level phenotypic human subjects data from this project to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive, which is part of the National Institutes of Mental Health (NIMH) Data Archive (NDA).

The project also involves collection of human specimens (fecal samples) which will generate non-human genomic data. Specifically, investigators plan to generate 300 (150 subjects x 2 timepoints) human gut microbiota metagenomes (i.e., gut microbiome). Deidentified genomic data (microbiome sequencing from the fecal samples) will be uploaded to the appropriate data repository upon NIH program administrator determination (NDA or the database of Genotypes and Phenotypes [dbGaP]).

Participants will be given the option in the consent/HIPAA form to allow the use of any leftover samples to bank for future undetermined analyses not specified in the protocol.

IPD Sharing Time Frame

Human phenotypic data will be uploaded at least twice a year, following NIMH Data Archive (NDA) requirements. Non-human genomes from fecal samples will be shared within 12 months of processing and genotyping all meta-genomes.

IPD Sharing Access Criteria

Data access will be through the National Institute of Mental Health Data Archive (NDA) and/or the database of Genotypes and Phenotypes (dbGaP).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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