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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

May 13, 2008
October 25, 2012
July 2007
July 2013   (final data collection date for primary outcome measure)
Behavioral Measures [ Time Frame: Baseline, +15, +25, +60, +300 ] [ Designated as safety issue: No ]
PANSS: Psychotic symptoms will be measured using the Positive and Negative Syndrome Scale (PANSS). Rey Auditory Verbal Learning Test (AVLT): a 15 word list learning task of verbal memory and hippocampal function that has 6 alternate versions. [ Time Frame: Baseline, +15, +25(RAVLT only), +60, +300 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00678730 on ClinicalTrials.gov Archive Site
Not Provided
CADSS:scale that measures perceptual alterations.Visual Analog Scale: a 16-item feeling state scale associated with cannabis.CANTAB: a computerized cognitive test battery is used to measure attention and memory. [ Time Frame: Baseline, +15, +35 (CANTAB only), +60, +300 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pharmacogenetics of Cannabinoid Response
Pharmacogenetics of Cannabinoid Response

This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
COMT Gene Polymorphism
Drug: delta 9 tetrahydrocannabinol
0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes
Other Names:
  • Marijuana
  • cannabis
  • 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".
    Intervention: Drug: delta 9 tetrahydrocannabinol
  • Placebo Comparator: 2
    small amount of ethanol, (quarter teaspoon), with no THC
    Intervention: Drug: delta 9 tetrahydrocannabinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
162
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 and 55 years (extremes included) on the day of the first dosing.

Exclusion Criteria:

  • Cannabis naïve individuals.
Both
18 Years to 55 Years
Yes
Contact: Lawrence Rispoli, B.A. 203-932-5711 ext 2525 lawrence.rispoli@yale.edu
United States
 
NCT00678730
0706002754, R01 DA 012382-05
Not Provided
Deepak C. D'Souza, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deepak D'Souza, M.D. Yale University
Yale University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP