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NCT Number: NCT02781519

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

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.

Recruiting

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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

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 naive individuals
  • major current or recent stressors
  • taking estrogen supplements or oral contraceptive pills (for women)

Treatment and study plan

THC

Drug

Active THC (0.015mg/kg) administered over 10 minutes

Other names: Delta-9-Tetrahydrocannabinol

Placebo

Drug

Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes

Primary outcomes

  1. Rewarding Effects measured by Visual Analog Scale (VAS)

    Time frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins

    subjective measure of THC induced "high"

  2. Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)

    Time frame: 25 minutes after THC infusion begins

    measured as delay recall on the AVLT

Study contacts

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

Christina Luddy, BS

CONTACT

[email protected]

203-932-5711 ext. 4549

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: THC-Gender

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
May 24, 2016
Registry last updated
Jun 10, 2025

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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