Addiction, Author Interviews, Opiods, Pharmacology / 30.04.2018
Can Opioid Users Be Transitioned To Extended-Release Naltrexone?
MedicalResearch.com Interview with:
Maria Sullivan, M.D., Ph.D
Senior Medical Director of Clinical Research and Development
Alkermes
MedicalResearch.com: What is the background for this study?
Response: Extended release injectable naltrexone is approved for the prevention of relapse to opioid dependence after detoxification and when used with counseling. It is recommended that patients abstain from opioids for a minimum of seven to 10 days prior to induction onto XR-naltrexone to avoid precipitating opioid withdrawal. This requirement of detoxification represents a substantial clinical challenge, particularly in the outpatient setting.
There is currently no single recognized best method for opioid detoxification prior to first dose of extended-release naltrexone (XR-naltrexone). A number of induction regimens have been explored, including the use of low doses of oral naltrexone to shorten the transition period from dependence on opioids to XR-naltrexone treatment. The goal of the study was to help establish an outpatient regimen to transition subjects from physiological opioid dependence to XR-naltrexone treatment and mitigate the severity of opioid withdrawal symptoms.
We hypothesized that low-dose oral naltrexone, combined with buprenorphine and psychoeducational counseling, would assist with the transition of patients with opioid use disorder onto XR-naltrexone. In this 3-arm trial, we examined the utility of oral naltrexone, buprenorphine, and a fixed regimen of ancillary medications (oral naltrexone + buprenorphine vs. oral naltrexone + placebo buprenorphine vs. placebo +placebo), to determine whether any of these regimens was associated with higher rates of induction onto XR-naltrexone.
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