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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA031664 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-Spectrum CBD | Experimental | 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). |
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| Broad- Spectrum CBD | Experimental | 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). |
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| Placebo | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-Spectrum Cannabidiol (CBD) | Drug | Dose: Approximately 200mg of full-spectrum CBD (<0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Week 4, Week 8, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbial Diversity | Gut microbial diversity from fecal samples collected at Baseline (prior to treatment) and Week 8. | Baseline, Week 8 |
| Change in Gut Permeability (Lipopolysaccharide Binding Protein [LBP]) |
Inclusion Criteria:
Exclusion Criteria:
Not everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hollis C Karoly, PhD | Contact | 303-724-7179 | hollis.karoly@cuanschutz.edu | |
| Landon Tomb, M.S. | Contact | 225-244-3429 | landon.tomb@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hollis C Karoly, PhD | University of Colorado School of Medicine- Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine- Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
Investigators will submit all de-identified individual level phenotypic human subjects data from this project to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive, which is part of the National Institutes of Mental Health (NIMH) Data Archive (NDA).
The project also involves collection of human specimens (fecal samples) which will generate non-human genomic data. Specifically, investigators plan to generate 300 (150 subjects x 2 timepoints) human gut microbiota metagenomes (i.e., gut microbiome). Deidentified genomic data (microbiome sequencing from the fecal samples) will be uploaded to the appropriate data repository upon NIH program administrator determination (NDA or the database of Genotypes and Phenotypes [dbGaP]).
Participants will be given the option in the consent/HIPAA form to allow the use of any leftover samples to bank for future undetermined analyses not specified in the protocol.
Human phenotypic data will be uploaded at least twice a year, following NIMH Data Archive (NDA) requirements. Non-human genomes from fecal samples will be shared within 12 months of processing and genotyping all meta-genomes.
Data access will be through the National Institute of Mental Health Data Archive (NDA) and/or the database of Genotypes and Phenotypes (dbGaP).
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000716407 | hempseed oil |
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| Broad-Spectrum Cannabidiol (CBD) | Drug | Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine. |
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| Placebo | Drug | Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine. |
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| Baseline, Week 8 |
Lipopolysaccharide Binding Protein levels in blood samples collected at Baseline (prior to treatment) and Week 8.
| Baseline, 8 Weeks |
| Change in Gut Permeability (CD14) | CD14 levels in blood samples collected at Baseline (prior to treatment) and Week 8. | Baseline, 8 Weeks |