Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02781519
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cannabis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • THC — DRUG
    Active THC (0.015mg/kg) administered over 10 minutes
  • Placebo — DRUG
    Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes

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, 2015
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Active Comparator: THC
    Active THC (0.015mg/kg) administered intravenously over 10 minutes.
  • Placebo Comparator: Placebo
    Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.

Primary Outcome Measure

Rewarding Effects measured by Visual Analog Scale (VAS) [ Time Frame: changes in "high" assessed over the following timepoints: baseline, +10, +80, and +200 minutes after THC infusion begins ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of MedicineWest HavenConnecticut06516
Christina Luddy, BS
[email protected]
203-932-5711

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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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