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

Cannabis Clinical Trial

— THC-Gender-I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02811510
• Other study ID #: 1505015940.A
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Carly Hewes, BS
• Phone: (203)932-5711
• Email: carly.hewes[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis

Intervention

Drug:
• Placebo
Placebo pill (no active cannabinoids)
• Dronabinol
10 mg capsule of Dronabinol will be administered orally.

Locations

Country	Name	City	State
United States	Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)	Subjective measure of THC induced "high"	changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
Primary	Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)	Measured as delay recall on the AVLT	baseline and +80 minutes after start of oral Dronabinol administration.