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Pharmacogenetics of Cannabinoid Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00678730
First received: May 13, 2008
Last updated: September 24, 2014
Last verified: September 2014
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacogenetics of Cannabinoid Response

Resource links provided by NLM:


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 2015
Estimated Primary Completion Date: July 2015 (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

  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
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

Contacts
Contact: Brynn Huguenel, B.A. 203-932-5711 ext 4650 brynn.huguenel@yale.edu
Contact: Christina Luddy, B.S. 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak D'Souza, M.D. Yale University
  More Information

No publications provided

Responsible Party: Deepak C. D'Souza, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00678730     History of Changes
Other Study ID Numbers: 0706002754, R01 DA 012382-05
Study First Received: May 13, 2008
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
THC
COMT gene polymorphism
schizophrenia
cannabis use

Additional relevant MeSH terms:
Dronabinol
Analgesics
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014