Phase 2 N=34 Randomized Double-blind Other

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

Pain Threshold · Mood

Bottom Line

View on ClinicalTrials.gov: NCT00743119 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Pain Tolerance — 6.1; 2.8; 4.9; 1.5 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo capsules (Drug); Inactive marijuana (0% THC) (Drug); Low dose Dronabinol (Drug); High dose Dronabinol (Drug); Low THC marijuana (Drug); High THC marijuana (Drug)
Age: Adult · 21+ yrs
Sex: Female
Sponsor: New York State Psychiatric Institute
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Tolerance	6.1; 2.8; 4.9; 1.5; 1.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.