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Recruiting NCT07225777

Sex Differences in Neurobehavioral Response to THC

Phase II Interventional Cannabis Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dronabinol, Placebo.
Who it may be relevant to
Registry conditions: Cannabis Use Disorder. Basic parameters: 21 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • Drug Dronabinol
    Oral dronabinol capsules (40 mg)
  • Drug Placebo
    Matched placebo capsules

Primary outcome measures

  • Nucleus accumbens glutamate [Time frame: 2 hours post-dose]
  • Striatal reward anticipation [Time frame: 3 hours post-dose]
Secondary outcome measures (4)
  • Drug Effects Questionnaire (DEQ) - Like Drug Effect [Time frame: 0-7 hours]
  • Drug Effects Questionnaire (DEQ) - Want More [Time frame: 0-7 hours]
  • Drug Effects Questionnaire (DEQ) - High [Time frame: 0-7 hours]
  • Nucleus accumbens GABA [Time frame: 2 hours post-dose]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07225777 · Pro00148223 · K12DA031794

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗