The "Conversion to Embeda® With Rescue Trial (ConvERT)" – Clinical Trials.gov identifier NCT01179191 – is recruiting participants at 124 study locations in more than 30 states.
Primary care provider research sites are recruiting about 1,300 individuals age 21 and older who have been taking a ‘round the clock’ opioid medication for at least 30 days for chonic moderate to severe pain of at least 3 months' duration.
“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.”
Note: Embeda is essentially a product designed to allow extended-release of morphine while preventing abuse of the drug. Pellets of morphine and naltrexone (which counteracts morphine's effect) are embedded in the pill. The morphine is timed to release over time so as to keep the level of morphine at a steady level around the clock, while the naltrexone pellets are designed to pass through the GI tract unabsorbed. The concept is that, while biting down on, crushing or dissolving & ingesting a pill containing only pure morphine would release all the morphine at the same time, creating a heightened immediate effect (potentially opioid abuse); if the naltrexone pellets are also crushed, all the naltrexone will also be released at the same time and counteract the opioid’s effect. This trial seems designed to determine the extent to which or under what circumstances primary care physicians may prescribe Embeda to their pain patients without significant risk of opioid abuse.
To read more about the study, the inclusion/exclusion criteria, and study site locations & contact information, go to the trial's ClinicalTrials.gov listing at http://clinicaltrials.gov/ct2/show/study/NCT01179191#locn