Recruiting
Phase 2

THC

Sponsor:

Medical University of South Carolina

Code:

NCT07815691

Conditions

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

Interventions

Dronabinol

Placebo

Study Details

Brief 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. 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

Study ID

NCT07815691

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able and willing to provide informed consent
2. Age 21-45
3. Meet DSM-5 criteria for CUD
4. Report cannabis use ≥4 days/week on average in the last 30 days at screening
5. Provide a THC-positive urine sample at screening
6. BMI between 18-30 kg/m2
7. Regular menstrual cycle (females only)
8. Willing to use non-hormonal birth control for the duration of study participation (females only)

Exclusion Criteria:

1. Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder
2. Urinalysis results indicative of recent drug use other than cannabis
3. Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes
4. Current treatment-seeking for CUD or other SUDs
5. Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
6. Females who are pregnant, nursing, or planning to become pregnant
7. MRI contraindications (e.g., metallic implants, claustrophobia)
8. Significant history of nausea associated with the use of cannabis and/or THC
9. History of cardiac or seizure disorders
10. Allergy to sesame oil

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Males

other: Females

Interventions

Dronabinol

Oral dronabinol capsules (40 mg)

Placebo

Matched placebo capsules

Primary outcome measure

  • Nucleus accumbens glutamate [ Time Frame: 2 hours post-dose ]
  • Drug Effects Questionnaire (DEQ) - Like Drug Effect [ Time Frame: 0-7 hours post-dose ]
  • Sex differences in genetics [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Erin Martin, Ph.D.

843-876-3528marterin@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Erin Martin, Ph.D.

843-876-3528marterin@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • Substance Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.