Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704271
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Cannabis Drug: Inhaled THC Drug: Placebo Phase 1

Detailed Description:
To characterize the acute effects of vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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: Sub-Study II
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Delta-9-Tetrahydrocannabinol (THC)
4 mg vaporized THC will be administered.
 Drug: Inhaled THC
4 mg inhaled THC
Other Name: Delta-9-Tetrahydrocannabinol
Placebo Comparator: Placebo
Inhaled placebo (no active cannabinoids)
 Drug: Placebo
Inhaled placebo (no active cannabinoids)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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"

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one lifetime exposure to cannabis
  • Good physical and mental health

Exclusion Criteria:

  • Cannabis naïve individuals
  • Major current or recent stressors
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704271


Contacts
Layout table for location contacts
Contact: Christina Luddy, BS 2039325711 ext 4549 christina.luddy@yale.edu

Locations
Layout table for location information
United States, Connecticut
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mohini Ranganathan, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT04704271    
Other Study ID Numbers: 1505015940.B
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists