Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
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

August 26, 2008
February 4, 2013
June 2008
October 2009   (final data collection date for primary outcome measure)
analgesic response [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
Cold water pressor task
Not Provided
Complete list of historical versions of study NCT00743119 on ClinicalTrials.gov Archive Site
intoxication [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
visual analog scales of cannabis intoxication
Not Provided
Not Provided
Not Provided
 
Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers
Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Pain
  • Mood
  • Drug: Oral THC
    0, 10, and 20 mg
    Other Name: marinol
  • Drug: Marijuana
    0%, 1.98% and 3.56%
    Other Name: cannabis
Experimental: oral THC, marijuana
smoked marijuana (0, 1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg)
Interventions:
  • Drug: Oral THC
  • Drug: Marijuana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2012
October 2009   (final data collection date for primary outcome measure)

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
Female
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743119
5603, 5P50DA009236
No
New York State Psychiatric Institute
New York State Psychiatric Institute
  • Research Foundation for Mental Hygiene, Inc.
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
New York State Psychiatric Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP