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

Verified June 2016 by Yale University

Sponsor:

Information provided by (Responsible Party):

Mohini Ranganathan, Yale University

ClinicalTrials.gov Identifier:

NCT02811510

First received: June 2, 2016

Last updated: June 20, 2016

Last verified: June 2016

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.

Cannabis	Drug: Placebo Drug: Dronabinol	Phase 1

Cannabis

Drug: Placebo
Drug: Dronabinol

Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Primary Outcome Measures:

Estimated Enrollment:	40
Study Start Date:	June 2016
Estimated Study Completion Date:	June 2020
Estimated Primary Completion Date:	June 2020 (Final data collection date for primary outcome measure)

Active Comparator: THC 10 mg Dronabinol will be administered orally.	Drug: Dronabinol 10 mg capsule of Dronabinol will be administered orally. Other Name: Delta-9-Tetrahydrocannabinol
Placebo Comparator: Placebo Placebo pill (no active cannabinoids).	Drug: Placebo Placebo pill (no active cannabinoids)

Active Comparator: THC

10 mg Dronabinol will be administered orally.

Drug: Dronabinol

10 mg capsule of Dronabinol will be administered orally.

Other Name: Delta-9-Tetrahydrocannabinol

Placebo Comparator: Placebo

Placebo pill (no active cannabinoids).

Drug: Placebo

Placebo pill (no active cannabinoids)

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.

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02811510

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, United States, 06516
Contact: Esra Sefik, BA 203-932-5711 ext 2557 esra.sefik@nullyale.edu
Principal Investigator: Mohini Ranganathan, MD

Yale University

Responsible Party:	Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT02811510 History of Changes
Other Study ID Numbers:	1505015940.A
Study First Received:	June 2, 2016
Last Updated:	June 20, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 25, 2016

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