Recruiting
Phase 1

Delta-9-Tetrahydrocannabinol

Sponsor:

Yale University

Code:

NCT02811510

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Placebo

Dronabinol

Study Details

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.

Conditions

Cannabis

Study ID

NCT02811510

Start date

Jun, 2016

Status verified date

Jun, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: THC

10 mg Dronabinol will be administered orally.

placebo comparator: Placebo

Placebo pill (no active cannabinoids).

Interventions

Placebo

Placebo pill (no active cannabinoids)

Dronabinol

10 mg capsule of Dronabinol will be administered orally.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Carly Hewes, BS

(203)932-5711carly.hewes@yale.edu

Locations

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

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Carly Hewes, BS

(203)932-5711carly.hewes@yale.edu

Principal Investigator:

Mohini Ranganathan, MD

More Information

Sponsor

Yale University

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-06-10.