Conditions: Chronic Disease Pain
Keywords: chronic pain Embeda opioid moderate pain severe pain conversion converting switching morphine aberrant behavior Pain (DT) + Chronic Disease (DT)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 684
Healthy volunteers: no

Brief summary:
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.

Detailed description:
The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.

Arms:
arm 1: None

Interventions: intervention 1: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention descriptions: intervention 1: Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.

Protocol document: