Recruiting
Phase 1

Delta-9-Tetrahydrocannabinol

Sponsor:

Yale University

Code:

NCT02781519

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

THC

Placebo

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

NCT02781519

Start date

Jun, 2015

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: THC

Active THC (0.015mg/kg) administered intravenously over 10 minutes.

placebo comparator: Placebo

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 10 minutes.

Interventions

THC

Active THC (0.015mg/kg) administered over 10 minutes

Placebo

Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes

Primary outcome measure

  • Rewarding Effects measured by Visual Analog Scale (VAS) [ 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) [ Time Frame: 25 minutes after THC infusion begins ]

Central Contacts and Locations

Central contacts

Christina Luddy, BS

203-932-5711christina.luddy@yale.edu

Locations

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

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Christina Luddy, BS

203-932-5711christina.luddy@yale.edu

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.