Cannabis Use DisorderPhase 2NCT07815691
Endocannabinoids in Reward
A Phase 2 study testing Dronabinol in people with Cannabis Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jul 2031
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to provide informed consent
- Age 21-45
- Meet DSM-5 criteria for CUD
- Report cannabis use ≥4 days/week on average in the last 30 days at screening
- Provide a THC-positive urine sample at screening
- BMI between 18-30 kg/m2
- Regular menstrual cycle (females only)
- Willing to use non-hormonal birth control for the duration of study participation (females only)
Who cannot join
- Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
- Urinalysis results indicative of recent drug use other than cannabis
- Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
- Current treatment-seeking for CUD or other SUDs
- Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
- Females who are pregnant, nursing, or planning to become pregnant
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- MRI contraindications (e.g., metallic implants, claustrophobia)
- Significant history of nausea associated with the use of cannabis and/or THC
- History of cardiac or seizure disorders
- Allergy to sesame oil
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
Medical University of South Carolina
Charleston, South Carolina, 29403
Erin Martin, Ph.D., 843-876-3528, marterin@musc.edu
About this study
Official title: The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.
- Conditions
- Cannabis Use Disorder
- Being tested
- Dronabinol, Placebo
- Keywords
- Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol
Oral dronabinol capsules (40 mg)
PlaceboDrug
Matched placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Males | Other | Not described Receives: Drug: Dronabinol; Drug: Placebo |
| Females | Other | Not described Receives: Drug: Dronabinol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleus accumbens glutamate
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Measured: 2 hours post-dose
Drug Effects Questionnaire (DEQ) - Like Drug Effect
Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours post-dose
Sex differences in genetics
Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system
Measured: Day 1
Secondary outcomes (3)
Dorsal striatal glutamate
Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy
Measured: 2 hours post-dose
Drug Effects Questionnaire (DEQ) - Want More
Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours post-dose
Drug Effects Questionnaire (DEQ) - High
Visual Analog Scale rating of subjective "high" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Oct 2026
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erin Martin, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815691
- Sponsor's protocol ID
- Pro00150333
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward
- ClinicalTrials.gov ID
- NCT07815691
- Acronym / sponsor ID
- Pro00150333
- Conditions
- Cannabis Use Disorder
- Keywords
- Substance Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 11 Sep 2026 (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.
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | Other | Drug: Dronabinol, Drug: Placebo |
| Females | Other | Drug: Dronabinol, Drug: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Able and willing to provide informed consent
- Age 21-45
- Meet DSM-5 criteria for CUD
- Report cannabis use ≥4 days/week on average in the last 30 days at screening
- Provide a THC-positive urine sample at screening
Key exclusion criteria (10 listed)
- Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
- Urinalysis results indicative of recent drug use other than cannabis
- Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
- Current treatment-seeking for CUD or other SUDs
- Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
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 |
|---|---|---|
| DronabinolAlso: MarinolOral dronabinol capsules (40 mg) | Drug | Females, Males |
| PlaceboMatched placebo capsules | Drug | Females, Males |
Primary outcome
Nucleus accumbens glutamate
Time frame: 2 hours post-dose
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Drug Effects Questionnaire (DEQ) - Like Drug Effect
Time frame: 0-7 hours post-dose
Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Sex differences in genetics
Time frame: Day 1
Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system
3 secondary outcomes
Dorsal striatal glutamate
Time frame: 2 hours post-dose
Drug Effects Questionnaire (DEQ) - Want More
Time frame: 0-7 hours post-dose
Drug Effects Questionnaire (DEQ) - High
Time frame: 0-7 hours post-dose
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 5 Oct 2026.
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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 in people with Cannabis Use Disorder, run by Medical University of South Carolina 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 8 inclusion and 10 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 5 Oct 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. 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 Erin Martin, Ph.D. (843-876-3528, marterin@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nucleus accumbens glutamate (time frame: 2 hours post-dose). 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 5 Oct 2026.