Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Overview
- Phase
- Phase 1
- Intervention
- THC
- Conditions
- Cannabis
- Sponsor
- Yale University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rewarding Effects measured by Visual Analog Scale (VAS)
- Status
- Recruiting
- Last Updated
- 10 months ago
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.
Investigators
Mohini Ranganathan
Assistant Professor of Psychiatry
Yale University
Eligibility Criteria
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)
Arms & Interventions
THC
Active THC (0.015mg/kg) administered intravenously over 10 minutes.
Intervention: THC
Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.
Intervention: Placebo
Outcomes
Primary Outcomes
Rewarding Effects measured by Visual Analog Scale (VAS)
Time Frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins
subjective measure of THC induced "high"
Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)
Time Frame: 25 minutes after THC infusion begins
measured as delay recall on the AVLT