Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Yale University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
Study Overview
Brief Summary
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Detailed Description
To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least one lifetime exposure to cannabis
- •Good physical and mental health
Exclusion Criteria
- •Cannabis naive individuals
- •Major current or recent stressors
- •Taking estrogen supplements or oral contraceptive pills (for women)
- •Sesame oil allergy
Arms & Interventions
THC
10 mg Dronabinol will be administered orally.
Intervention: Dronabinol (Drug)
Placebo
Placebo pill (no active cannabinoids).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
Time Frame: baseline and +80 minutes after start of oral Dronabinol administration.
Measured as delay recall on the AVLT
Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
Time Frame: changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
Subjective measure of THC induced "high"
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohini Ranganathan
Assistant Professor of Psychiatry
Yale University