Alcohol Use DisorderPhase 2CAPNCT07279558
Cannabidiol and Alcohol Use Disorder Phenotypes
A Phase 2 study testing Full-Spectrum Cannabidiol (CBD) and Broad-Spectrum Cannabidiol (CBD) in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Full-Spectrum Cannabidiol (CBD) and Broad-Spectrum Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 31 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado School of Medicine- Anschutz Medical Campus
Aurora, Colorado, 80045
Hollis C Karoly, PhD, 303-724-7179, hollis.karoly@cuanschutz.edu
Landon C Tomb, MS, 225-244-3429, landon.tomb@cuanschutz.edu
About this study
Official title: Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Full-Spectrum Cannabidiol (CBD), Broad-Spectrum Cannabidiol (CBD), Placebo
- Keywords
- Alcohol, Cannabidiol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Spectrum Cannabidiol (CBD)Drug
Also called Hemp-derived, full-spectrum cannabidiol, Ecofibre USA/Ananda Hemp
Dose: 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)Drug
Also called Hemp-derived, broad-spectrum cannabidiol, Ecofibre USA/Ananda Hemp
Dose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine.
PlaceboDrug
Also called 100% Hemp Seed Oil, Ecofibre USA/Ananda Hemp
Active Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Full-Spectrum Cannabidiol (CBD) |
| 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). Receives: Drug: Broad-Spectrum Cannabidiol (CBD) |
| 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary 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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start21 Apr 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Hollis C Karoly, PhD, Principal investigator, University of Colorado School of Medicine- Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279558
- Sponsor's protocol ID
- 25-1612
- Other IDs
- R01AA031664
- Acronym
- CAP
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Full-spectrum Cannabidiol on Alcohol Consumption and Alcohol Use Disorder Phenotypes: Implications for Precision Medicine
- ClinicalTrials.gov ID
- NCT07279558
- Acronym / sponsor ID
- CAP / 25-1612
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-Spectrum CBD | Experimental | Drug: Full-Spectrum Cannabidiol (CBD)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). |
| Broad- Spectrum CBD | Experimental | Drug: Broad-Spectrum Cannabidiol (CBD)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). |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-Spectrum Cannabidiol (CBD)Also: Hemp-derived, full-spectrum cannabidiol, Ecofibre USA/Ananda HempDose: Approximately 200mg of full-spectrum CBD (<0.3% THC) Active Ingredients: Full spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine. | Drug | Full-Spectrum CBD |
| Broad-Spectrum Cannabidiol (CBD)Also: Hemp-derived, broad-spectrum cannabidiol, Ecofibre USA/Ananda HempDose: Approximately 200mg of broad-spectrum CBD, (0% THC) Active Ingredients: Broad spectrum hemp extract Other Ingredients: Hemp seed oil, glycerin, gelatine. | Drug | Broad- Spectrum CBD |
| PlaceboAlso: 100% Hemp Seed Oil, Ecofibre USA/Ananda HempActive Ingredients: N/A Other Ingredients: Hemp seed oil, glycerin, gelatine. | Drug | Placebo |
Primary outcome
Alcohol Self-Administration During the Bar Lab Task
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Change in Negative Emotionality ANA Domain Score
Time frame: Baseline, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hollis C Karoly, PhD principal investigator
University of Colorado School of Medicine- Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Full-Spectrum Cannabidiol (CBD) and Broad-Spectrum Cannabidiol (CBD) in people with Alcohol Use Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hollis C Karoly, PhD (303-724-7179, hollis.karoly@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Self-Administration During the Bar Lab Task (time frame: Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.