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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Dose: Approximately 200mg of full-spectrum CBD (\<0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
University of Colorado School of Medicine- Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGAlcohol Self-Administration During the Bar Lab Task
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.
Time frame: Week 8
Change in Self-Report of Drinking Behavior (Drinks Per Drinking Day)
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.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Phosphatidylethanol (PEth)
Phosphatidylethanol (PEth) concentration in blood samples collected at Baseline (prior to treatment), Week 4, Week 8, and Week 12.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Negative Emotionality ANA Domain Score
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.
Time frame: Baseline, Week 8
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