Pharmacogenetics of Cannabinoid Response

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Deepak C. D'Souza, Yale University

ClinicalTrials.gov Identifier:

NCT00678730

First received: May 13, 2008

Last updated: June 21, 2017

Last verified: June 2017

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Basic Science
Official Title:	Pharmacogenetics of Cannabinoid Response

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

U.S. FDA Resources

Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:

Behavioral Measures [ Time Frame: Baseline, +15, +25, +60, +300 ]


Estimated Enrollment:	162
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2018
Estimated Primary Completion Date:	July 2018 (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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Connecticut
VA Connecticut Healthcare System
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


Responsible Party:	Deepak C. D'Souza, Principal Investigator, Yale University
ClinicalTrials.gov Identifier:	NCT00678730 History of Changes
Other Study ID Numbers:	0706002754
Study First Received:	May 13, 2008
Last Updated:	June 21, 2017

Keywords provided by Deepak C. D'Souza, Yale University:


THC COMT gene polymorphism schizophrenia cannabis use

Additional relevant MeSH terms:


Ethanol Dronabinol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 27, 2017

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