Actively Recruiting
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II
Led by Yale University · Updated on 2026-04-29
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the immediate effects of vaporized Delta-9-Tetrahydrocannabinol (THC) in healthy adults, focusing on differences between women and men. The study explores potential mechanisms behind these gender-related effects to provide a clearer picture of how THC impacts individuals differently based on sex. The trial is a Phase 1, randomized, quadruple-masked study conducted by Yale University with healthy adult volunteers aged 18 to 55 who have previously used cannabis. Participants will receive either 4 mg of vaporized THC or an inhaled placebo with no active cannabinoids. The study compares these two groups to assess the acute effects of THC. The treatments are administered through inhalation, and the study is designed to carefully monitor responses to these interventions. Throughout the study, participants will be evaluated on various measures including their subjective feeling of being "high" using a Visual Analog Scale (VAS) at multiple timepoints after treatment, and their verbal learning ability measured by the Rey Auditory Verbal Learning Test (RAVLT). These assessments help researchers understand changes from baseline following THC or placebo inhalation. The study also includes safety monitoring and lasts until the completion date in December 2027.
CONDITIONS
Brief Title
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II
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
- Both men and women are eligible
You will not qualify if you...
- Cannabis naive individuals
- Major current or recent stressors
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 for each treatment session with washout periods in between
Participants receive inhaled vaporized THC or placebo in a randomized crossover design to study acute effects.
2 treatment visits (in-person), one for each intervention
Duration - Up to 5 hours post-treatment per session
Participants are monitored for acute effects and changes from baseline after each treatment session.
Repeated assessments during each treatment visit
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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