drugset / Trial / NCT01380093

Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

NCT01380093

Phase 1 Completed 80 enrolled Pfizer
RandomizedCrossoverDouble-blindBasic science

Summary

The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.

Timeline

Start
2011-02
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 120 mg Oral
Subject Naltrexone Small molecule 2.4 mg Oral

Indications