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

NCT01595867 Phase 1 COMPLETED

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.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	2010-08
Completion	2011-01

Conditions

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

Interventions

• Placebo
• EMBEDA - morphine sulfate/ naltrexone hydrochloride
• morphine sulfate CR crushed.

Primary outcomes

• Drug Liking Visual Analog Scale maximum peak effect (Emax) — 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
• Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) — 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
• High Visual Analog Scale maximum peak effect (Emax) — pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
• High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) — pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose