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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02811510
Acronym
THC-Gender-I
Enrollment
40
Registered
2016-06-23
Start date
2016-06-30
Completion date
2026-12-31
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis

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.

Detailed description

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.

Interventions

DRUGPlacebo

Placebo pill (no active cannabinoids)

DRUGDronabinol

10 mg capsule of Dronabinol will be administered orally.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)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
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)baseline and +80 minutes after start of oral Dronabinol administration.Measured as delay recall on the AVLT

Countries

United States

Contacts

Primary ContactCarly Hewes, BS
carly.hewes@yale.edu(203)932-5711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026