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

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ClinicalTrials.gov Identifier: NCT00743119
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 26, 2008
First Posted Date  ICMJE August 28, 2008
Results First Submitted Date  ICMJE October 20, 2016
Results First Posted Date  ICMJE December 11, 2017
Last Update Posted Date December 11, 2017
Study Start Date  ICMJE June 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00743119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Official Title  ICMJE Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Placebo-controlled, double-blind
Primary Purpose: Other
Condition  ICMJE
  • Pain Threshold
  • Mood
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2008)
48
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743119
Other Study ID Numbers  ICMJE 5603
5P50DA009236 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE
  • Research Foundation for Mental Hygiene, Inc.
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date November 2017

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