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Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743119
First Posted: August 28, 2008
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
August 26, 2008
August 28, 2008
October 20, 2016
December 11, 2017
December 11, 2017
June 2008
October 2009   (Final data collection date for primary outcome measure)
Pain Tolerance [ Time Frame: Within each session lasting approximately 5 minutes, for a total of five sessions ]
Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).
Not Provided
Complete list of historical versions of study NCT00743119 on ClinicalTrials.gov Archive Site
Not Provided
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Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Oral THC (dronabinol) is known to have a slower onset and longer duration of action compared with smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and last longer than effects produced by smoked marijuana.
Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the cannabinoid system, however, these effects have et to be clearly elucidated in humans. To better understand the potential clinical application of cannabinoids for pain management, the following study is designed to determine the analgesic efficacy of smoked marijuana (3.56% THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana smokers will be recruited for a five-session study during which the analgesic, subjective, and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose, route of administration, time course) or this effect to further investigate the potential role for clinical use of smoked marijuana and/or oral THC as analgesics.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Placebo-controlled, double-blind
Primary Purpose: Other
  • Pain Threshold
  • Mood
  • Drug: Placebo capsules
    Placebo capsules
  • Drug: Inactive marijuana (0% THC)
    Inactive marijuana cigarettes (0% THC) provided by NIDA
  • Drug: Low dose Dronabinol
    Dronabinol 10mg
  • Drug: High dose Dronabinol
    Dronabinol 20mg
  • Drug: Low THC marijuana
    marijuana cigarettes (1.98% THC) provided by NIDA
  • Drug: High THC marijuana
    Marijuana cigarettes (3.56% THC) provided by NIDA
  • Placebo Comparator: Placebo + inactive marijuana (0% THC)
    Participants received placebo capsules and smoked inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
    Interventions:
    • Drug: Placebo capsules
    • Drug: Inactive marijuana (0% THC)
  • Experimental: Dronabinol 10 mg + Marijuana (0% THC)
    Participants received low dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
    Interventions:
    • Drug: Inactive marijuana (0% THC)
    • Drug: Low dose Dronabinol
  • Experimental: Dronabinol 20 mg + Marijuana (0% THC)
    Participants received High dose Dronabinol + inactive marijuana (0% THC) on 1 of 5 outpatient sessions in randomized order.
    Interventions:
    • Drug: Inactive marijuana (0% THC)
    • Drug: High dose Dronabinol
  • Experimental: Placebo + Marijuana (1.98% THC)
    Participants received placebo + low THC marijuana (1.98% THC) on 1 of 5 outpatient sessions in randomized order.
    Interventions:
    • Drug: Placebo capsules
    • Drug: Low THC marijuana
  • Experimental: Placebo + Marijuana (3.56% THC)
    Participants received placebo + smoked high THC marijuana (3.56 % THC) on 1 of 5 outpatient sessions in randomized order.
    Interventions:
    • Drug: Placebo capsules
    • Drug: High THC marijuana
Cooper ZD, Comer SD, Haney M. Comparison of the analgesic effects of dronabinol and smoked marijuana in daily marijuana smokers. Neuropsychopharmacology. 2013 Sep;38(10):1984-92. doi: 10.1038/npp.2013.97. Epub 2013 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
May 2013
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults between the ages of 21-45
  • Current marijuana use
  • Able to perform study procedures
  • Women practicing an effective form of birth control

Exclusion Criteria:

  • Female subjects who are currently pregnant or breastfeeding
  • Current,repeated illicit drug use other than marijuana
  • Presence of significant medical illness
  • History of heart disease
  • Request for drug treatment
  • Current parole or probation
  • Recent history of significant violent behavior
Sexes Eligible for Study: Female
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00743119
5603
5P50DA009236 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
New York State Psychiatric Institute
New York State Psychiatric Institute
  • Research Foundation for Mental Hygiene, Inc.
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
New York State Psychiatric Institute
November 2017

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