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NCT Number: NCT07279558

Cannabidiol and Alcohol Use Disorder Phenotypes

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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

Treatment and study plan

Full-Spectrum Cannabidiol (CBD)

Drug

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

Broad-Spectrum Cannabidiol (CBD)

Drug

Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.

Other names: Hemp-derived, broad-spectrum cannabidiol, Ecofibre USA/Ananda Hemp

Placebo

Drug

Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.

Other names: 100% Hemp Seed Oil, Ecofibre USA/Ananda Hemp

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Change in Gut Permeability (CD14)

    Time frame: Baseline, 8 Weeks

    CD14 levels in blood samples collected at Baseline (prior to treatment) and Week 8.

Study contacts

Contact information is provided by the study sponsor or research team.

Hollis C Karoly, PhD

CONTACT

[email protected]

303-724-7179

Landon Tomb, M.S.

CONTACT

[email protected]

225-244-3429

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: CAP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 12, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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