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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743119
• Other study ID #: 5603
• Secondary ID: 5P50DA009236
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: November 7, 2017
• Start date: June 2008
• Est. completion date: May 2013

Study information

• Verified date: November 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Mood
• Pain Threshold

Intervention

Drug:
• Placebo capsules
Placebo capsules
• Inactive marijuana (0% THC)
Inactive marijuana cigarettes (0% THC) provided by NIDA
• Low dose Dronabinol
Dronabinol 10mg
• High dose Dronabinol
Dronabinol 20mg
• Low THC marijuana
marijuana cigarettes (1.98% THC) provided by NIDA
• High THC marijuana
Marijuana cigarettes (3.56% THC) provided by NIDA

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cooper ZD, Comer SD, Haney M. Comparison of the analgesic effects of dronabinol and smoked marijuana in daily marijuana smokers. Neuropsychopharmacology. 2013 Sep;38(10):1984-92. doi: 10.1038/npp.2013.97. Epub 2013 Apr 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Tolerance	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).	Within each session lasting approximately 5 minutes, for a total of five sessions