Examining how gender affects the immediate effects of THC in healthy individuals
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
This study is testing how a synthetic form of THC affects healthy men and women differently to see if gender plays a role in its effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT02811510 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the acute effects of Dronabinol, a synthetic form of THC, in healthy men and women. Participants will receive either a placebo or a 10 mg capsule of Dronabinol to assess how gender influences the drug's effects. The research will also explore the underlying mechanisms that may contribute to any observed differences between genders. By focusing on individuals with prior cannabis exposure, the study seeks to provide insights into gender-related responses to cannabinoids.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals with prior cannabis exposure, regardless of gender.
Not a fit: Patients who are cannabis naive or have significant stressors or hormonal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how gender influences cannabinoid effects, leading to more personalized treatment approaches.
How similar studies have performed: While studies on cannabinoids exist, this specific focus on gender differences in acute effects is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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) * Sesame oil allergy
Where this trial is running
West Haven, Connecticut
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Carly Hewes, BS
- Email: carly.hewes@yale.edu
- Phone: (203)932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.