Overview

This trial is active, not recruiting.

Condition comt gene polymorphism
Treatment delta 9 tetrahydrocannabinol
Phase phase 1
Sponsor Yale University
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2007
End date July 2017
Trial size 162 participants
Trial identifier NCT00678730, 0706002754

Summary

This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Very low dose (0.005 mg/kg = 0.35 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/10th of a marijuana cigarette, or "joint". Low dose (0.025 mg/kg = 1.75 mg in a 70kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1/2 of a marijuana cigarette, or "joint". Medium dose (0.05 mg/kg = 3.5 mg in a 70 kg individual) THC, dissolved in ethanol. This dose is roughly equivalent to smoking 1 marijuana cigarette, or "joint".
delta 9 tetrahydrocannabinol Marijuana
0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes
(Placebo Comparator)
small amount of ethanol, (quarter teaspoon), with no THC
delta 9 tetrahydrocannabinol Marijuana
0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes

Primary Outcomes

Measure
Behavioral Measures
time frame: Baseline, +15, +25, +60, +300

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - 18 and 55 years (extremes included) on the day of the first dosing. Exclusion Criteria: - Cannabis naïve individuals.

Additional Information

Official title Pharmacogenetics of Cannabinoid Response
Principal investigator Deepak D'Souza, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.