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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02811510
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cannabis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Placebo pill (no active cannabinoids)
  • Dronabinol — DRUG
    10 mg capsule of Dronabinol will be administered orally.

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: THC
    10 mg Dronabinol will be administered orally.
  • Placebo Comparator: Placebo
    Placebo pill (no active cannabinoids).

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of MedicineWest HavenConnecticut06516
Carly Hewes, BS
[email protected]
(203)932-5711
Mohini Ranganathan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine· West Haven, CT

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