Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I

Phase 1

Recruiting

• Conditions: Cannabis
• Interventions: Drug: Placebo; Drug: Dronabinol

• Registration Number: NCT02811510
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo pill (no active cannabinoids).
THC	Dronabinol	10 mg Dronabinol will be administered orally.

Primary Outcome Measures

Name	Time	Method
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)	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)	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"

Trial Locations

Locations (1)

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine; 🇺🇸 West Haven, Connecticut, United States