Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID02811510

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

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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