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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04704271
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cannabis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Inhaled THC — DRUG
    4 mg inhaled THC
  • Placebo — DRUG
    Inhaled placebo (no active cannabinoids)

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
Oct 9, 2019
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

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

Arms

  • Active Comparator: Delta-9-Tetrahydrocannabinol (THC)
    4 mg vaporized THC will be administered.
  • Placebo Comparator: Placebo
    Inhaled placebo (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
Christina Luddy, BS
[email protected]
203-932-5711
Mohini Ranganathan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Haven, CT

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

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