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Pharmacogenetics of Cannabinoid Response

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ClinicalTrials.gov Identifier: NCT00678730
Recruitment Status : Active, not recruiting
First Posted : May 15, 2008
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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".

Condition or disease Intervention/treatment Phase
COMT Gene Polymorphism Drug: delta 9 tetrahydrocannabinol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacogenetics of Cannabinoid Response
Study Start Date : July 2007
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral Measures [ Time Frame: Baseline, +15, +25, +60, +300 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deepak C. D'Souza, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00678730     History of Changes
Other Study ID Numbers: 0706002754
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 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