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: May 19, 2016
Last verified: May 2016
  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 2016
Estimated Primary Completion Date: July 2016 (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   (Adult)
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

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: May 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 25, 2016