NCT01595867

Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

Conditions

• Narcotic Abuse
• Opioid-related Disorders
• Analgesia
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Placebo	Lactose (100 mg) placebo tablets crushed; single dose
DRUG	EMBEDA - morphine sulfate/ naltrexone hydrochloride	EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
DRUG	morphine sulfate CR crushed.	Morphine sulfate controlled release 30 mg tablet crushed

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2012-05-10
• Last updated: 2012-06-08