NCT07225777

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

November 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

November 5, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

Substance Use

Outcome Measures

Primary Outcomes (2)

  • Nucleus accumbens glutamate

    Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

    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

    3 hours post-dose

Secondary Outcomes (4)

  • Drug Effects Questionnaire (DEQ) - Like Drug Effect

    0-7 hours

  • Drug Effects Questionnaire (DEQ) - Want More

    0-7 hours

  • Drug Effects Questionnaire (DEQ) - High

    0-7 hours

  • Nucleus accumbens GABA

    2 hours post-dose

Study Arms (2)

Males

OTHER
Drug: DronabinolDrug: Placebo

Females

OTHER
Drug: DronabinolDrug: Placebo

Interventions

Matched placebo capsules

FemalesMales

Oral dronabinol capsules (40 mg)

Also known as: Marinol
FemalesMales

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Erin Martin, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor-Faculty

Study Record Dates

First Submitted

November 5, 2025

First Posted

November 10, 2025

Study Start

April 27, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations