Health TrialsbyHealthPanel

Sex Differences in Neurobehavioral Response to THC

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-45
SponsorMedical University of South Carolina

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 21-45

DSM-5 criteria for CUD

Cannabis use ≥4 days/week

THC-positive urine

Disqualifiers

Lifetime psychotic or bipolar disorder

Recent drug use other than cannabis

Current psychotropic medication

Treatment-seeking for SUD

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dronabinol

    Drug

    Oral dronabinol capsules (40 mg)

  • Placebo

    Drug

    Matched placebo capsules

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: MalesOther 2 interventions
Group B: FemalesOther 2 interventions

Trial outcomes

Primary outcomes

1

Nucleus accumbens glutamate

Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

Time frame
2 hours post-dose
2

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

Time frame
3 hours post-dose

Secondary outcomes

1

Drug Effects Questionnaire (DEQ) - Like Drug Effect

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.

Time frame
0-7 hours
2

Drug Effects Questionnaire (DEQ) - Want More

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.

Time frame
0-7 hours
3

Drug Effects Questionnaire (DEQ) - High

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.

Time frame
0-7 hours
4

Nucleus accumbens GABA

Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy

Time frame
2 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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