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

Phase 1
Recruiting
Conditions
Cannabis
Interventions
Drug: Inhaled THC
Drug: Placebo
Registration Number
NCT04704271
Lead Sponsor
Yale University
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 vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • At least one lifetime exposure to cannabis
  • Good physical and mental health
Read More
Exclusion Criteria
  • Cannabis naïve individuals
  • Major current or recent stressors
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Delta-9-Tetrahydrocannabinol (THC)Inhaled THC4 mg vaporized THC will be administered.
PlaceboPlaceboInhaled placebo (no active cannabinoids)
Primary Outcome Measures
NameTimeMethod
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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

🇺🇸

West Haven, Connecticut, United States

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