Actively Recruiting
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Led by Yale University · Updated on 2025-06-10
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how oral Dronabinol, a form of Delta-9-Tetrahydrocannabinol (THC), affects healthy adults differently based on gender. The study focuses on understanding the immediate effects of cannabinoids in women compared to men and investigating the biological reasons behind any observed gender differences. Participants will receive either a 10 mg oral capsule of Dronabinol or a placebo pill containing no active cannabinoids. The study is randomized and includes a placebo-controlled group. The treatment effects will be monitored at specific timepoints following administration to assess changes in subjective feelings of being "high" and verbal learning abilities. During the study, participants will be evaluated using the Visual Analog Scale (VAS) to measure rewarding effects at multiple intervals up to 300 minutes after taking the dose. Verbal learning will be assessed using the Rey Auditory Verbal Learning Test (RAVLT) at baseline and 80 minutes after dosing. The trial is designed to carefully track these outcomes to understand the acute effects of cannabinoids and any gender-related differences.
CONDITIONS
Brief Title
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one lifetime exposure to cannabis
- Good physical and mental health
- Age between 18 and 55 years
- All genders eligible
You will not qualify if you...
- Cannabis naive individuals
- Major current or recent stressors
- Taking estrogen supplements or oral contraceptive pills (for women)
- Sesame oil allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single-day dosing sessions with washout periods between sessions
Participants receive oral doses of either 10 mg Dronabinol or placebo in a randomized crossover design to assess acute effects.
2 dosing visits (in-person), one for each treatment
Trial Site Locations
Total: 1 location
1
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
C
Carly Hewes, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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