Sex Differences in Neurobehavioral Response to THC

Phase 2RecruitingNCT07225777

Medical University of South Carolina40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Cannabis Use Disorder

Interventions

DronabinolDRUG

Oral dronabinol capsules (40 mg)

PlaceboDRUG

Matched placebo capsules

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Medical University of South Carolina

Charleston, South Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Nucleus accumbens glutamate

Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

Time frame: 2 hours post-dose

Striatal reward anticipation

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

Time frame: 3 hours post-dose

Secondary Outcomes

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.

Time frame: 0-7 hours

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.

Time frame: 0-7 hours

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.

Time frame: 0-7 hours

Nucleus accumbens GABA

Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy

Time frame: 2 hours post-dose

Data from ClinicalTrials.gov

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