Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
THC-Gender-I
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 10, 2025
June 1, 2025
10 years
June 2, 2016
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
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)
Measured as delay recall on the AVLT
baseline and +80 minutes after start of oral Dronabinol administration.
Study Arms (2)
THC
ACTIVE COMPARATOR10 mg Dronabinol will be administered orally.
Placebo
PLACEBO COMPARATORPlacebo pill (no active cannabinoids).
Interventions
10 mg capsule of Dronabinol will be administered orally.
Eligibility Criteria
You may qualify if:
- At least one lifetime exposure to cannabis
- Good physical and mental health
You may not qualify if:
- Cannabis naive individuals
- Major current or recent stressors
- Taking estrogen supplements or oral contraceptive pills (for women)
- Sesame oil allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 23, 2016
Study Start
June 1, 2016
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share