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
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Sponsor:
New York State Psychiatric Institute
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
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Tracking Information | |||||
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First Submitted Date ICMJE | August 26, 2008 | ||||
First Posted Date ICMJE | August 28, 2008 | ||||
Results First Submitted Date | October 20, 2016 | ||||
Results First Posted Date | 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 |
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).
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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 Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | 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 | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Masking Description: Placebo-controlled, double-blind Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
34 | ||||
Original Estimated Enrollment ICMJE |
48 | ||||
Actual Study Completion Date | May 2013 | ||||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers | 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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | New York State Psychiatric Institute | ||||
Study Sponsor ICMJE | New York State Psychiatric Institute | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |