Rapid Procedure Noninferior for Extended-Release Naltrexone Initiation

THURSDAY, May 9, 2024 (HealthDay News) -- For patients with opioid use disorder (OUD), a rapid procedure (RP) is noninferior to a standard procedure for initiation of extended-release (XR) naltrexone, according to a study published online May 8 in JAMA Network Open.

Matisyahu Shulman, M.D., from the Columbia University Irving Medical Center in New York City, and colleagues compared the effectiveness of SP, with approximately five-day buprenorphine taper followed by a seven- to 10-day opioid free period, to the effectiveness of RP, defined as one day of buprenorphine and one opioid-free day, for XR naltrexone initiation. Units using the SP were randomly assigned to implement the RP at 14-week intervals. Participants admitted with OUD received the procedure that was being delivered at the unit at the time of admission.

A total of 415 patients with OUD were enrolled. The researchers found that the rate of successful initiation of XR naltrexone was 62.7 percent in the RP group, which was noninferior to the rate of 35.8 percent in the SP group (odds ratio, 3.60). There was no significant difference observed between the groups in withdrawal. Targeted safety events and serious adverse events occurred rarely but were more common with RP than SP.

"In future studies, the implementation strategies used in the present trial could be broadened to encompass initiation of buprenorphine and methadone, addressing the larger goal of maximizing the proportion of patients with OUD admitted to inpatient or residential treatment who emerge stabilized on medications for OUD," the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Alkermes, which together with Emmes Company donated Vivitrol (naltrexone for XR injectable suspension) for the study.

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