Pharmacogenetics of Cannabinoid Response

Yale University

Status and phase: Completed; Early Phase 1

Conditions: COMT Gene Polymorphism

Treatments: Drug: delta 9 tetrahydrocannabinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00678730

0706002754

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Cannabis naïve individuals.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

* 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".

Treatment:

Drug: delta 9 tetrahydrocannabinol

2

Placebo Comparator group

Description:

small amount of ethanol, (quarter teaspoon), with no THC

Treatment:

Drug: delta 9 tetrahydrocannabinol