Sex Differences in Neurobehavioral Response to THC

Medical University of South Carolina (MUSC)

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Drug: Placebo; Drug: Dronabinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07225777

Pro00148223

K12DA031794 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Males

Other group

Treatment:

Drug: Dronabinol

Drug: Placebo

Females

Other group

Treatment:

Drug: Dronabinol

Drug: Placebo