Pharmacogenetics of Cannabinoid Response

Early Phase 1

Completed

• Conditions: COMT Gene Polymorphism
• Interventions: Drug: delta 9 tetrahydrocannabinol

• Registration Number: NCT00678730
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-15
• Primary Completion: 2014-09-11
• Study Completion: 2014-09-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 18 and 55 years (extremes included) on the day of the first dosing.

Exclusion Criteria

• Cannabis naïve individuals.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	delta 9 tetrahydrocannabinol	* 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".
2	delta 9 tetrahydrocannabinol	small amount of ethanol, (quarter teaspoon), with no THC

Primary Outcome Measures

Name	Time	Method
Behavioral Measures	Baseline, +15, +25, +60, +300

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States