Sex Differences in Neurobehavioral Response to THC

Not Applicable

Not yet recruiting

• Conditions: Cannabis Use Disorder
• Interventions: Drug: Dronabinol; Drug: Placebo

• Registration Number: NCT07225777
• Lead Sponsor: Medical University of South Carolina

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-05
• Study First Submitted QC: 2025-11-05
• Last Update Submitted: 2025-11-05
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2026-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Males	Dronabinol	-
Males	Placebo	-
Females	Dronabinol	-
Females	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States