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| Sponsor: | New York State Psychiatric Institute |
|---|---|
| Collaborators: |
Research Foundation for Mental Hygiene National Institute on Drug Abuse (NIDA) |
| Information provided by: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00743119 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Mood |
Drug: Oral THC Drug: Marijuana |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-Treatment Seeking Marijuana Smokers |
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2008 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret Haney, Ph.D | 212-543-5175 |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Margaret Haney, Ph.D | New York State Psychiatric Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00743119 History of Changes |
| Other Study ID Numbers: | 5603 |
| Study First Received: | August 26, 2008 |
| Last Updated: | August 26, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
oral thc smoked marijuana pain analgesic effects |
|
Marijuana Abuse Substance-Related Disorders Mental Disorders Analgesics Tetrahydrocannabinol Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic |
