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/38832949/Actively Recruiting
Led by Yale University · Updated on 2025-06-10
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
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 mgkg 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
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
C
Christina Luddy, BS
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Yale University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | THC (investigational) | Placebo (control) |
|---|---|---|
| What it is | Administration of active THC (delta‑9‑tetrahydrocannabinol) to healthy adults in a randomized crossover design | Administration of placebo control (no THC) in the same participants under crossover conditions |
| Role in trial | Investigational condition | Control condition |
| Primary use/effect measured | To assess acute subjective (“high”), psychotomimetic, learning and physiological effects following THC | To assess baseline or non‑THC responses during placebo for comparison |
| Administration | Single THC dose (e.g., 10 mg oral or 0.015 mg/kg IV over 10 minutes) administered under controlled conditions | Matching placebo dose (e.g., small alcohol amount, no THC) administered under same conditions |
| Evidence status | Human laboratory data available on acute effects of oral THC, including sex differences | Baseline responses documented for comparison; placebo confirms no THC effects |
| Important risks | Acute THC may impair cognition, increase heart rate, and induce psychotomimetic effects | Placebo expected to have no THC‑related adverse effects |
| Limitations | Findings from single‑dose, healthy adult volunteers may not generalize to clinical populations or chronic cannabis users | Placebo condition reflects controlled non‑THC exposure, not real‑world absence of cannabis |
| Patient‑relevant findings | This laboratory data helps clarify how acute THC affects sensations of being “high,” memory, and physiology in healthy individuals | Placebo condition illustrates effects without active THC for comparison |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Ardavan Mohammad Aghaei, Lia Urban Spillane, Brian Pittman...
https://pubmed.ncbi.nlm.nih.gov/38832949/Yale University
Lead Sponsor