Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
| Status: | Archived |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | June 2011 |
A Single-Center, Randomized, Double-Blind, Two-Way Crossover Study to Evaluate Whether a Single-Dose Administration of Crushed and Whole EMBEDAâ„¢ Induces Clinical Opiate Withdrawal Signs and Symptoms in Opioid-Dependent Patients With Chronic, Non-Cancer Pain Who Are Stabilized on EMBEDAâ„¢
This study will evaluate whether crushed EMBEDAâ„¢ capsules induce clinical opiate withdrawal
signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are
stabilized on EMBEDAâ„¢.
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.
We found this trial at
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