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Pharmacogenetics of Cannabinoid Response

This study is currently recruiting participants.
Verified June 2012 by Yale University
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: October 25, 2012
Last verified: June 2012
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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacogenetics of Cannabinoid Response

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
Drug Information available for: Dronabinol
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 2013
Estimated Primary Completion Date: July 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678730

Contacts
Contact: Lawrence Rispoli, B.A. 203-932-5711 ext 2525 lawrence.rispoli@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 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: October 25, 2012
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 May 22, 2013