Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

Phase 1

Recruiting

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

• Registration Number: NCT02781519
• 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

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-24
• 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: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.
THC	THC	Active THC (0.015mg/kg) administered intravenously over 10 minutes.

Primary Outcome Measures

Name	Time	Method
Rewarding Effects measured by Visual Analog Scale (VAS)	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)	25 minutes after THC infusion begins	measured as delay recall on the AVLT

Trial Locations

Locations (1)

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