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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02781519
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
102
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: THC

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

Drug: THC
Active THC (0.015mg/kg) administered over 10 minutes
Other Names:
  • Delta-9-Tetrahydrocannabinol

    		•
    Placebo Comparator: Placebo

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Rewarding Effects measured by Visual Analog Scale (VAS) [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) [25 minutes after THC infusion begins]

      measured as delay recall on the AVLT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine West Haven Connecticut United States 06516

    Sponsors and Collaborators

    • Yale University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University
    ClinicalTrials.gov Identifier:
    NCT02781519
    Other Study ID Numbers:
    • 1505015940
    First Posted:
    May 24, 2016
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Marijuana Abuse
    Dronabinol

    Study Results

    No Results Posted as of Jul 22, 2022