NCT00743145

Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

Conditions

• Marijuana Smoking

Interventions

Type	Name	Description
DRUG	Inactive Marijuana (0% THC)	Marijuana cigarette containing 0% THC
DRUG	Active Marijuana (5.5% THC)	Marijuana cigarette containing 5.5% THC
DRUG	Active Marijuana (6.2% THC)	Marijuana cigarette containing 6.2% THC
DRUG	Naltrexone	Naltrexone (12mg/70kg)
DRUG	Placebo naltrexone	Naltrexone (0mg)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2008-08-28
• Last updated: 2018-09-14
• Results posted: 2018-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study