Cannabidiol and Alcohol Use Disorder Phenotypes
CAP
Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
2 other identifiers
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
February 13, 2026
February 1, 2026
3.6 years
December 10, 2025
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Alcohol Self-Administration During the Bar Lab Task
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)
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)
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 Outcomes (1)
Change in Negative Emotionality ANA Domain Score
Baseline, Week 8
Other Outcomes (3)
Change in Gut Microbial Diversity
Baseline, Week 8
Change in Gut Permeability (Lipopolysaccharide Binding Protein [LBP])
Baseline, 8 Weeks
Change in Gut Permeability (CD14)
Baseline, 8 Weeks
Study Arms (3)
Full-Spectrum CBD
EXPERIMENTALSubjects 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).
Broad- Spectrum CBD
EXPERIMENTALSubjects 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).
Placebo
PLACEBO COMPARATORSubjects 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).
Interventions
Dose: Approximately 200mg of full-spectrum CBD (\<0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
Eligibility Criteria
You may qualify if:
- Age 21-65
- Have used CBD and cannabis at least once in the last year
- Regularly drink alcohol
- Able to provide informed consent and attend in-person study visits
You may not qualify if:
- Current use of medications known to have major interaction with Epidiolex, Marinol, or alcohol
- Current use of antiepileptic medication or any psychotropic medication besides antidepressants
- Pregnant, nursing, or planning a pregnancy
- Medical conditions that contraindicates the use of CBD or alcohol
- Current medical conditions that may require intensive care during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado School of Medicine- Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hollis C Karoly, PhD
University of Colorado School of Medicine- Anschutz Medical Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2025
First Posted
December 12, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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).
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 360 (180 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.