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

ConditionCannabis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least one lifetime exposure to cannabis

Good physical and mental health

Disqualifiers

Cannabis naive individuals

Major current or recent stressors

Taking estrogen supplements or oral contraceptive pills (for women)

Sesame oil allergy

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: THCActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)

Subjective measure of THC induced "high"

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)

Measured as delay recall on the AVLT

Time frame

baseline and +80 minutes after start of oral Dronabinol administration.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov

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