Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers
This study has been completed.
First Posted: August 28, 2008
Last Update Posted: February 5, 2013
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Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
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.
Drug: Oral THC
||Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
||Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers
Primary Outcome Measures:
- analgesic response [ Time Frame: 7 hours ]
Cold water pressor task
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Experimental: oral THC, marijuana
smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg)
Drug: Oral THC
0, 10, and 20 mg
Other Name: marinol
0%, 1.98% and 3.56%
Other Name: cannabis
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.