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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02811510
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
90
Duration (Months)
0.4
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

Detailed Description

To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 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: Sub-Study I
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: THC

10 mg Dronabinol will be administered orally.

Drug: Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Other Names:
  • Delta-9-Tetrahydrocannabinol

    		•
    Placebo Comparator: Placebo

    Placebo pill (no active cannabinoids).

    Drug: Placebo
    Placebo pill (no active cannabinoids)

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS) [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) [baseline and +80 minutes after start of oral Dronabinol administration.]

      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)

    • Sesame oil allergy

    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:
    NCT02811510
    Other Study ID Numbers:
    • 1505015940.A
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Marijuana Abuse
    Dronabinol

    Study Results

    No Results Posted as of Jul 27, 2022