Recruiting
Phase 2

CBD

Sponsor:

University of Colorado, Denver

Code:

NCT07279558

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Full-Spectrum Cannabidiol (CBD)

Broad-Spectrum Cannabidiol (CBD)

Placebo

Study Details

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.

Conditions

Alcohol Use Disorder

Study ID

NCT07279558

Start date

Mar 31, 2026

Status verified date

Mar, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

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).

Interventions

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.

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.

Placebo

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

Primary outcome measure

  • Alcohol Self-Administration During the Bar Lab Task [ Time Frame: Week 8 ]
  • Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day) [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
  • Change in Phosphatidylethanol (PEth) [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]

Central Contacts and Locations

Central contacts

Hollis C Karoly, PhD

303-724-7179hollis.karoly@cuanschutz.edu

Landon Tomb, M.S.

225-244-3429landon.tomb@cuanschutz.edu

Locations

University of Colorado School of Medicine- Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hollis C Karoly, PhD

303-724-7179hollis.karoly@cuanschutz.edu

Landon C Tomb, MS

225-244-3429landon.tomb@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Alcohol
  • Cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-03.