Cannabis Use DisorderPhase 2NCT06446479
Effects of THC on Alcohol Consumption and Neural Correlates of Reward
A Phase 2 study testing Dronabinol Pill in people with Cannabis Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Dronabinol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Jun 2026
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Drink alcohol
- Use cannabis
- Contact site for additional details
Who cannot join
- MRI contraindications (implanted metal, weight > 315 lb, etc.).
- Contact site for additional details
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 Anschutz Medical Campus
Aurora, Colorado, 80045
Elnaz Nourollahimoghadam, MD, 303-724-6020, elnaz.nourollahimoghadam@cuanschutz.edu
About this study
Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.
Read the detailed description
Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy
- Conditions
- Cannabis Use Disorder
- Being tested
- Dronabinol Pill, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol PillDrug
Dronabinol 20 mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo first, Dronabinol second | Experimental | This arm will receive placebo on the first visit, and dronabinol on the second visit Receives: Drug: Dronabinol Pill; Drug: Placebo |
| Dronabinol first, Placebo second | Experimental | This arm will receive dronabinol on the first visit, and placebo on the second visit. Receives: Drug: Dronabinol Pill; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Measured: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Change in cannabis cue-elicited brain activation (fMRI) between medication periods
Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
Measured: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol self-administration
Number of drinks self-administered
Measured: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Self-reported alcoholic drinks consumed
# of drinks consumed per day
Measured: one report per day for the 14 days after the final laboratory visit on day 14.
Self-reported cannabis use
Amount of cannabis consumed per day
Measured: One report per day for the 14 days after the final laboratory visit on day 14
Self-reported cannabis and alcohol co-use
Number of days in which cannabis and alcohol were both used
Measured: One report per day for the 14 days after the final laboratory visit on day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 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), Colorado State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446479
- Sponsor's protocol ID
- 22-1314
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of THC on Alcohol Consumption and Neural Correlates of Reward
- ClinicalTrials.gov ID
- NCT06446479
- Acronym / sponsor ID
- 22-1314
- Conditions
- Cannabis Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Colorado State University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.
Detailed description
Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first, Dronabinol second | Experimental | Drug: Dronabinol Pill, Drug: PlaceboThis arm will receive placebo on the first visit, and dronabinol on the second visit |
| Dronabinol first, Placebo second | Experimental | Drug: Dronabinol Pill, Drug: PlaceboThis arm will receive dronabinol on the first visit, and placebo on the second visit. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Drink alcohol
- Use cannabis
- Contact site for additional details
Key exclusion criteria (2 listed)
- MRI contraindications (implanted metal, weight > 315 lb, etc.).
- Contact site for additional details
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 |
|---|---|---|
| Dronabinol PillDronabinol 20 mg | Drug | Dronabinol first, Placebo second, Placebo first, Dronabinol second |
| Placeboplacebo | Drug | Dronabinol first, Placebo second, Placebo first, Dronabinol second |
Primary outcome
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Change in cannabis cue-elicited brain activation (fMRI) between medication periods
Time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
Alcohol self-administration
Time frame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Number of drinks self-administered
Self-reported alcoholic drinks consumed
Time frame: one report per day for the 14 days after the final laboratory visit on day 14.
# of drinks consumed per day
Self-reported cannabis use
Time frame: One report per day for the 14 days after the final laboratory visit on day 14
Amount of cannabis consumed per day
Self-reported cannabis and alcohol co-use
Time frame: One report per day for the 14 days after the final laboratory visit on day 14.
Number of days in which cannabis and alcohol were both used
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 19 Aug 2024.
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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.
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 Dronabinol Pill in people with Cannabis 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 3 inclusion and 2 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 19 Aug 2024. 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. 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 Elnaz Nourollahimoghadam (3037246020, elnaz.nourollahimoghadam@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol cue-elicited brain activation (fMRI) between medication periods (time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.). The study lists 6 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 19 Aug 2024.