Alcohol Use Disorder
Conditions
Keywords
Alcohol, Cannabidiol
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.
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
DRUGFull-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.
DRUGBroad-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.
DRUGPlacebo
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
Sponsors
University of Colorado, Denver
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Self-Administration During the Bar Lab Task | 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. |
| Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day) | 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. |
| Change in Phosphatidylethanol (PEth) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Negative Emotionality ANA Domain Score | 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. |
Countries
United States
Contacts
CONTACTHollis C Karoly, PhD
CONTACTLandon Tomb, M.S.
PRINCIPAL_INVESTIGATORHollis C Karoly, PhD
University of Colorado School of Medicine- Anschutz Medical Campus
Outcome results
None listed