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Sex Differences in Neurobehavioral Response to THC

NCT ID: NCT07225777

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Cannabis Use Disorder

Keywords

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Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Males

Group Type OTHER

Dronabinol

Intervention Type DRUG

Oral dronabinol capsules (40 mg)

Placebo

Intervention Type DRUG

Matched placebo capsules

Females

Group Type OTHER

Dronabinol

Intervention Type DRUG

Oral dronabinol capsules (40 mg)

Placebo

Intervention Type DRUG

Matched placebo capsules

Interventions

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Dronabinol

Oral dronabinol capsules (40 mg)

Intervention Type DRUG

Placebo

Matched placebo capsules

Intervention Type DRUG

Other Intervention Names

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Marinol

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Martin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Facility Contacts

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Erin Martin, Ph.D.

Role: primary

Other Identifiers

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K12DA031794

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00148223

Identifier Type: -

Identifier Source: org_study_id