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

NCT ID: NCT02811510

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cannabis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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THC

10 mg Dronabinol will be administered orally.

Group Type ACTIVE_COMPARATOR

Dronabinol

Intervention Type DRUG

10 mg capsule of Dronabinol will be administered orally.

Placebo

Placebo pill (no active cannabinoids).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill (no active cannabinoids)

Interventions

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Placebo

Placebo pill (no active cannabinoids)

Intervention Type DRUG

Dronabinol

10 mg capsule of Dronabinol will be administered orally.

Intervention Type DRUG

Other Intervention Names

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Delta-9-Tetrahydrocannabinol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mohini Ranganathan

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

West Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carly Hewes, BS

Role: CONTACT

(203)932-5711 ext. 7411

Facility Contacts

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Carly Hewes, BS

Role: primary

(203)932-5711 ext. 7411

Other Identifiers

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1505015940.A

Identifier Type: -

Identifier Source: org_study_id

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