Sex Differences in Neurobehavioral Response to THC

NCT07225777 — Phase 2, Terminated, 5 participants, Medical University of South Carolina

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Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder

Registry	NCT07225777
Status	Terminated - Funding status change.
Phase	Phase 2
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	5 (Actual)
Sponsor	Medical University of South Carolina (Other); collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Conditions	Cannabis Use Disorder
Interventions	Dronabinol, Placebo (Drug)
Dates	start 2026-04-27, primary completion 2026-08-31, completion 2026-08-31, first posted 2025-11-10, last updated 2026-10-06
Locations	1 site in United States

-Summary

This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Participants will complete two counterbalanced dosing sessions (oral THC 40 mg vs. placebo).

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+Arms and interventions

Arm	Type	Interventions	Description
Males	Other	Drug: Dronabinol; Drug: Placebo
Females	Other	Drug: Dronabinol; Drug: Placebo

Dronabinol (Drug), also known as Marinol: Oral dronabinol capsules (40 mg)
Placebo (Drug): Matched placebo capsules

+Outcome measures

Primary outcomes

Nucleus accumbens glutamate [2 hours post-dose]: Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Striatal reward anticipation [3 hours post-dose]: Blood oxygen-level-dependent (BOLD) signaling in the striatum (caudate, putamen, nucleus accumbens) measured using functional magnetic resonance imaging (fMRI) during a monetary reward task

Secondary outcomes

Drug Effects Questionnaire (DEQ) - Like Drug Effect [0-7 hours]: 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.
Drug Effects Questionnaire (DEQ) - Want More [0-7 hours]: 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.
Drug Effects Questionnaire (DEQ) - High [0-7 hours]: 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.
Nucleus accumbens GABA [2 hours post-dose]: Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy

+Eligibility

Sex: All, ages: 21 Years to 45 Years

Inclusion Criteria:

* Age 21-45
* DSM-5 criteria for CUD
* Cannabis use ≥4 days/week
* THC-positive urine
* BMI 18-30
* Regular menstrual cycle (females)
* Willingness to use non-hormonal birth control (females)

Exclusion Criteria:

* Lifetime psychotic or bipolar disorder
* Recent drug use other than cannabis
* Current psychotropic medication
* Treatment-seeking for SUD
* Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)
* Pregnancy/nursing
* MRI contraindications

+Locations (1)

Facility	City	Country	Status
Medical University of South Carolina	Charleston, South Carolina	United States

+Study documents

Informed Consent Form (PDF, 2026-05-22)

+Investigators

Erin Martin, Ph.D., Principal investigator, Medical University of South Carolina

+Funding

NIH grants: K12DA031794