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Sex Differences in Neurobehavioral Response to THC

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07225777
Enrollment
5
Registered
2025-11-10
Start date
2026-04-27
Completion date
2026-08-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder

Keywords

Substance Use

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).

Interventions

DRUGDronabinol

Oral dronabinol capsules (40 mg)

DRUGPlacebo

Matched placebo capsules

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Nucleus accumbens glutamate2 hours post-doseConcentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Striatal reward anticipation3 hours post-doseBlood 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

MeasureTime frameDescription
Drug Effects Questionnaire (DEQ) - Like Drug Effect0-7 hoursVisual 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 More0-7 hoursVisual 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) - High0-7 hoursVisual 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 GABA2 hours post-doseConcentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORErin Martin, Ph.D.

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026