Sex differences in the acute effects of oral THC: a randomized, placebo-controlled, crossover human laboratory study.
Ardavan Mohammad Aghaei, Lia Urban Spillane, Brian Pittman...
https://pubmed.ncbi.nlm.nih.gov/38832949Actively Recruiting
Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID02781519
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Led by Yale University · Updated on 2025-06-10
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the acute effects of cannabinoids, specifically Delta-9-Tetrahydrocannabinol (THC), in healthy adults to understand how these effects differ between women and men. This Phase 1 trial aims to explore the potential underlying mechanisms that might explain gender-related differences in response to THC. Participants receive either an active dose of THC (0.015 mg/kg) administered intravenously over 10 minutes or a placebo consisting of a small amount of alcohol (a quarter teaspoon) given intravenously with no THC, also over 10 minutes. The study is randomized and uses quadruple masking to maintain objectivity in evaluating the effects. During the study, researchers assess the rewarding effects of THC using a Visual Analog Scale at multiple time points after the infusion begins, including baseline, 10, 80, and 200 minutes. Additionally, verbal learning is evaluated using the Rey Auditory Verbal Learning Test 25 minutes post-infusion. The trial includes healthy volunteers aged 18 to 55 years, and participation involves monitoring these cognitive and subjective effects of THC.
CONDITIONS
Brief Title
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
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 are eligible
You will not qualify if you...
- Cannabis naive individuals
- Major current or recent stressors
- Taking estrogen supplements or oral contraceptive pills (for women)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single session for each intervention
Participants receive active THC or placebo administered intravenously over 10 minutes in a randomized crossover design.
2 visits (in-person) for each intervention administration
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
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Research Team
C
Christina Luddy, 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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