Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID04704271

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

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
  • Both men and women are eligible
Not Eligible

You will not qualify if you...

  • Cannabis naive individuals
  • Major current or recent stressors

AI-Screening

AI-Powered Screening

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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 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

Follow-up

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

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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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