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Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

2014-08-27 03:14:43 | BioPortfolio

Summary

This study will evaluate whether crushed EMBEDA™ capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA™.

Description

This study will investigate the occurrence of signs and symptoms of withdrawal in patients with chronic non-cancer pain stabilized on EMBEDA, as determined by the Clinical Opiate Withdrawal Scale (COWS), when their normal morning dose is crushed, (simulating a patient that chews their morning dose). Patients will be brought into a controlled environment, and under medical supervision, receive separate treatments of crushed EMBEDA capsules and whole EMBEDA capsules.

Since previous PK studies have shown that crushing EMBEDA results in the immediate release of both morphine sulfate and naltrexone HCl, present in a 25:1 ratio, it is unclear what effect the antagonist activity of naltrexone may have to precipitate withdrawal if EMBEDA is crushed or chewed. Previously the pharmacodynamic (PD) effects of EMBEDA were not completely blocked by the amount of naltrexone in EMBEDA so it is hypothesized that upon ingestion of a crushed dose of EMBEDA, opioid-tolerant patients may experience minimal to mild signs and symptoms of opioid withdrawal.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Conditions

Chronic Pain

Intervention

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crushed

Location

Salt Lake City
Utah
United States

Status

Recruiting

Source

Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:43-0400

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