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Completed

NCT Number: NCT00743119

Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers

The following study is designed to determine the analgesic efficacy of smoked marijuana (0, 1.98, 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. Oral THC (dronabinol) 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.

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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 (3.56% THC) and oral THC (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo capsules

Drug

Placebo capsules

Inactive marijuana (0% THC)

Drug

Inactive marijuana cigarettes (0% THC) provided by NIDA

Low dose Dronabinol

Drug

Dronabinol 10mg

High dose Dronabinol

Drug

Dronabinol 20mg

Low THC marijuana

Drug

marijuana cigarettes (1.98% THC) provided by NIDA

High THC marijuana

Drug

Marijuana cigarettes (3.56% THC) provided by NIDA

Primary outcomes

  1. Pain Tolerance

    Time frame: Within each session lasting approximately 5 minutes, for a total of five sessions

    Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Research Foundation for Mental Hygiene, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Aug 28, 2008
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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