- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704271
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II (THC-Gender-II)
April 17, 2023 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
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 Type
Interventional
Enrollment (Anticipated)
100
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
- Name: Christina Luddy, BS
- Phone Number: 4549 2039325711
- Email: christina.luddy@yale.edu
Study Locations
-
-
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
-
-
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 naïve individuals
- Major current or recent stressors
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: Delta-9-Tetrahydrocannabinol (THC)
4 mg vaporized THC will be administered.
|
4 mg inhaled THC
Other Names:
|
Placebo Comparator: Placebo
Inhaled placebo (no active cannabinoids)
|
Inhaled placebo (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
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 (Actual)
October 9, 2019
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
January 7, 2021
First Submitted That Met QC Criteria
January 7, 2021
First Posted (Actual)
January 11, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- 1505015940.B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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