Cannabidiol and Alcohol Use Disorder Phenotypes
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Full-Spectrum Cannabidiol (CBD)
DrugDose: 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)
DrugDose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
Placebo
DrugActive Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Full-Spectrum CBDExperimental treatment 1 intervention
Group B: Broad- Spectrum CBDExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Alcohol 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 82
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 123
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 12Secondary outcomes
1
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 8Other outcomes
1
Change in Gut Microbial Diversity
Gut microbial diversity from fecal samples collected at Baseline (prior to treatment) and Week 8.
Time frame
Baseline, Week 82
Change in Gut Permeability (Lipopolysaccharide Binding Protein [LBP])
Lipopolysaccharide Binding Protein levels in blood samples collected at Baseline (prior to treatment) and Week 8.
Time frame
Baseline, 8 Weeks3
Change in Gut Permeability (CD14)
CD14 levels in blood samples collected at Baseline (prior to treatment) and Week 8.
Time frame
Baseline, 8 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov