Recruiting NCT02811510
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Dronabinol.
- Who it may be relevant to
- Registry conditions: Cannabis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Placebo
Placebo pill (no active cannabinoids) - Drug Dronabinol
10 mg capsule of Dronabinol will be administered orally.
Primary outcome measures
- 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.]
- Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT) [Time frame: baseline and +80 minutes after start of oral Dronabinol administration.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine — West Haven
Identifiers
NCT: NCT02811510 · 1505015940.A