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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.
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crushed
Salt Lake City
Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.
Published on BioPortfolio: 2014-08-27T03:14:43-0400
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The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle.
An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.
Strong dependence, both physiological and emotional, upon morphine.
Analogs or derivatives of morphine.
A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.
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