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
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Characterization of the Analgesic Effects of Oral THC and Smoked Marijuana in Non-treatment Seeking Marijuana Smokers

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • analgesic response [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Cold water pressor task


Secondary Outcome Measures:
  • intoxication [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    visual analog scales of cannabis intoxication


Enrollment: 26
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Marijuana
0%, 1.98% and 3.56%
Other Name: cannabis

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

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743119

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Margaret Haney, Ph.D New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743119     History of Changes
Other Study ID Numbers: 5603, 5P50DA009236
Study First Received: August 26, 2008
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
oral thc
smoked marijuana
pain
analgesic effects

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics
Dronabinol
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
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014