drugset / Trial / NCT01179191
Conversion to Embeda With Rescue Trial
NaSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-04
- Completion
- 2011-04
Publications
- Setnik B, Roland CL, Pixton GC, Sommerville KW. Prescription opioid abuse and misuse: gap between primary-care investigator assessment and actual extent of these behaviors among patients with chronic pain. Postgrad Med. 2017 Jan;129(1):5-11. doi: 10.1080/00325481.2017.1245585. Epub 2016 Oct 26.
- Setnik B, Roland CL, Sommerville KW, Pixton GC, Berke R, Calkins A, Goli V. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide. J Pain Res. 2015 Jul 8;8:347-60. doi: 10.2147/JPR.S82395. eCollection 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Morphine | Other / unclassified | 20 mg | Oral |
| Subject | Morphine | Other / unclassified | 100 mg | Oral |
| Subject | Naltrexone | Small molecule | 0.8 mg | Oral |
| Subject | Naltrexone | Small molecule | 4 mg | Oral |
Indications
No indication recorded.