Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-Treatment Seeking Marijuana Smokers
Information source: New York State Psychiatric Institute
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Mood
Intervention: Oral THC (Drug); Marijuana (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s):
Margaret Haney, Ph.D, Principal Investigator, Affiliation: New York State Psychiatric Institute
Overall contact:
Margaret Haney, Ph.D, Phone: 212-543-5175
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.
Clinical Details
Official title: Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-Treatment Seeking Marijuana Smokers
Study design: Treatment, Randomized, Double-Blind, Single Group Assignment, Efficacy Study
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Margaret Haney, Ph.D, Phone: 212-543-5175
New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Additional Information
Starting date: June 2008
Last updated: August 26, 2008
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