Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II
Overview
- Phase
- Phase 1
- Intervention
- Inhaled THC
- Conditions
- Cannabis
- Sponsor
- Yale University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
- Status
- Recruiting
- Last Updated
- last year
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 vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Investigators
Mohini Ranganathan
Associate Professor of Psychiatry
Yale University
Eligibility Criteria
Inclusion Criteria
- •At least one lifetime exposure to cannabis
- •Good physical and mental health
Exclusion Criteria
- •Cannabis naïve individuals
- •Major current or recent stressors
Arms & Interventions
Delta-9-Tetrahydrocannabinol (THC)
4 mg vaporized THC will be administered.
Intervention: Inhaled THC
Placebo
Inhaled placebo (no active cannabinoids)
Intervention: Placebo
Outcomes
Primary Outcomes
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"
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