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Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00743119
First received: August 26, 2008
Last updated: February 4, 2013
Last verified: February 2013
| Tracking Information | ||||
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| First Received Date ICMJE | August 26, 2008 | |||
| Last Updated Date | February 4, 2013 | |||
| Start Date ICMJE | June 2008 | |||
| Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
analgesic response [ Time Frame: 7 hours ] Cold water pressor task |
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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 |
intoxication [ Time Frame: 7 hours ] visual analog scales of cannabis intoxication |
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| 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 | Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers | |||
| Official Title ICMJE | Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers | |||
| Brief Summary | The purpose of this study is 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 (0. 198, 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. Both smoked marijuana and oral THC will produce dose- and time-dependent analgesic effects in the cold-pressor test. Oral THC 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 (0, 1.98, 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. 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 | Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms | Experimental: oral THC, marijuana
smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg)
Interventions:
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| Publications * | Not Provided | |||
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* 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 | |||
| Enrollment ICMJE | 26 | |||
| Completion Date | December 2012 | |||
| 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 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| 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 | February 2013 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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