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NCT Number: NCT04704271

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

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Key information

Conditions

Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Christina Luddy, BS

CONTACT

[email protected]

203-932-5711 ext. 4549

Mohini Ranganathan, MD

PRINCIPAL_INVESTIGATOR

About this study

To characterize the acute effects of vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one lifetime exposure to cannabis
  • Good physical and mental health

Exclusion criteria

  • Cannabis naïve individuals
  • Major current or recent stressors

Treatment and study plan

Inhaled THC

Drug

4 mg inhaled THC

Other names: Delta-9-Tetrahydrocannabinol

Placebo

Drug

Inhaled placebo (no active cannabinoids)

Primary outcomes

  1. Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)

    Time frame: Changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.

    Subjective measure of THC induced "high"

  2. Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Baseline and +80 minutes after start of oral Dronabinol administration.

    Measured as delay recall on the AVLT

Study contacts

Contact information is provided by the study sponsor or research team.

Carly Hewes, BS

CONTACT

[email protected]

2039325711 ext. 7411

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: THC-Gender-II

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 11, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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