Cannabidiol and Alcohol Use Disorder Phenotypes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full-Spectrum Cannabidiol (CBD), Broad-Spectrum Cannabidiol (CBD), Placebo.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
Overview
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.
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.
Interventions
- 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. - 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. - Drug Placebo
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Change in Negative Emotionality ANA Domain Score [Time frame: Baseline, Week 8]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado School of Medicine- Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT07279558 · 25-1612 · R01AA031664