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

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)

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: THCActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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, +10, +80, and +200 minutes after THC infusion begins

Verbal Learning: measured by Rey Auditory Verbal Learning Test (AVLT)

measured as delay recall on the AVLT

Time frame

25 minutes after THC infusion begins

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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