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

Phase 1RecruitingNCT04704271

Yale University100 enrolled

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.

To characterize the acute effects of vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

100

Conditions

Cannabis

Interventions

Inhaled THCDRUG

4 mg inhaled THC

PlaceboDRUG

Inhaled placebo (no active cannabinoids)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * At least one lifetime exposure to cannabis * Good physical and mental health Exclusion Criteria: * Cannabis naïve individuals * Major current or recent stressors

Locations (1)

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

West Haven, Connecticut, United States

RECRUITING

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.

Central Contacts

Carly Hewes, BS

CONTACT

2039325711 carly.hewes@yale.edu

Data from ClinicalTrials.gov

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