Cannabidiol and Alcohol Use Disorder Phenotypes

Purpose

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.

Condition

  • Alcohol Use Disorder

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • Hemp-derived, broad-spectrum cannabidiol
    • Ecofibre USA/Ananda Hemp
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:
    • 100% Hemp Seed Oil
    • Ecofibre USA/Ananda Hemp

Recruiting Locations

University of Colorado School of Medicine- Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
Hollis C Karoly, PhD
303-724-7179
hollis.karoly@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Hollis C Karoly, PhD
303-724-7179
hollis.karoly@cuanschutz.edu

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.