Pharmacogenetics of Cannabinoid Response - Full Text View

Sponsor:	Yale University
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00678730

Purpose

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

Condition	Intervention	Phase
COMT Gene Polymorphism	Drug: delta 9 tetrahydrocannabinol	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Pharmacogenetics of Cannabinoid Response

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Marijuana

Drug Information available for: GW-1000 Tetrahydrocannabinol Cannabis

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Behavioral Measures [ Time Frame: Baseline, +15, +25, +60, +300 ] [ Designated as safety issue: No ]

Estimated Enrollment:	162
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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".	Drug: delta 9 tetrahydrocannabinol 0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes Other Names: Marijuana cannabis
Placebo Comparator: 2 small amount of ethanol, (quarter teaspoon), with no THC	Drug: delta 9 tetrahydrocannabinol 0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes Other Names: Marijuana cannabis

Arms

Assigned Interventions

Active Comparator: 1

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".

Drug: delta 9 tetrahydrocannabinol

0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes

Other Names:

Marijuana
cannabis

Placebo Comparator: 2

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

Drug: delta 9 tetrahydrocannabinol

0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes

Other Names:

Marijuana
cannabis

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cannabis naïve individuals.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678730

Contacts

Contact: Jacqueline P Elander, B.A.

2039325711 ext 4523

jacqueline.elander@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Deepak D'Souza, M.D.

Yale University

More Information

No publications provided

Responsible Party:	Deepak Cyril D'Souza, M.D., Yale University School of Medicine, Dept of Psychiatry
ClinicalTrials.gov Identifier:	NCT00678730 History of Changes
Other Study ID Numbers:	0706002754, R01 DA 012382-05
Study First Received:	May 13, 2008
Last Updated:	July 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

THC
COMT gene polymorphism
schizophrenia
cannabis use

Additional relevant MeSH terms:

Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012