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

May 1, 2024 updated by: Mohini Ranganathan, Yale University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
        • Principal Investigator:
          • Mohini Ranganathan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
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
baseline and +80 minutes after start of oral Dronabinol administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimated)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1505015940.A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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