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NCT Number: NCT07225777

Sex Differences in Neurobehavioral Response to THC

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).

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Key information

Conditions

Cannabis Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location status: Recruiting

Location contact

Erin Martin, Ph.D.

CONTACT

[email protected]

843-876-3528

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol

Drug

Oral dronabinol capsules (40 mg)

Other names: Marinol

Placebo

Drug

Matched placebo capsules

Primary outcomes

  1. Nucleus accumbens glutamate

    Time frame: 2 hours post-dose

    Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

  2. Striatal reward anticipation

    Time frame: 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 outcomes

  1. Drug Effects Questionnaire (DEQ) - Like Drug Effect

    Time frame: 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.

  2. Drug Effects Questionnaire (DEQ) - Want More

    Time frame: 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.

  3. Drug Effects Questionnaire (DEQ) - High

    Time frame: 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.

  4. Nucleus accumbens GABA

    Time frame: 2 hours post-dose

    Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 10, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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