Rapid Procedural Approach Increases Opioid Treatment Initiation but Faces Resource Challenges
A rapid procedural (RP) approach to withdrawal management and initiation of injectable extended-release (XR)-naltrexone for opioid use disorder (OUD) helped more patients begin treatment but may be difficult to implement widely due to intensive staffing needs.
Findings from a stepped-wedge cluster randomized clinical trial were published in JAMA Network Open, with researchers concluding that the RP was “noninferior” to the standard procedure (SP).
“This cluster trial demonstrated that an RP for initiating XR-naltrexone consisting of minimal buprenorphine, use of higher doses of nonopioid medications for opioid withdrawal, and titration of low doses of oral naltrexone is feasible, relatively safe, and noninferior, compared with the SP recommended in the XR-naltrexone prescribing information,” said Matisyahu Shulman, MD, department of psychiatry, New York State Psychiatric Institute and Columbia University Irving Medical Center, and co-authors.
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The study authors aimed to compare the RP (a 5-7 day program) versus the SP (a 12-14 day program detailed on the medication package insert) for XR-naltrexone initiation. The trial was conducted across 6 community-based inpatient addiction treatment centers. Centers using the SP were randomly assigned at 14-week intervals to instead implement the RP. Patients admitted for OUD treatment received whichever procedure their specific clinic was assigned at the time. The primary outcome under measure was receipt of an XR-naltrexone injection before patient discharge. Additional outcomes included opioid withdrawal scores, targeted safety events, and serious adverse events.
Over the study period, 415 patients (205 men, 210 women) were enrolled and randomized to receive either RP or SP. Rates of successful initiation of XR-naltrexone among the RP group (141 of 225 [62.7%]) were noninferior to those of the SP group (68 of 190 [35.8%]) (odds ratio [OR], 3.60; 95% CI, 2.12-6.10). Withdrawal did not differ significantly between conditions (proportion of days with a moderate or greater maximum Clinical Opiate Withdrawal Scale score (>12) for RP vs SP: OR, 1.25; 95% CI, 0.62-2.50). Targeted safety events (RP: 12 [5.3%]; SP: 4 [2.1%]) and serious adverse events (RP: 15 [6.7%]; SP: 3 [1.6%]) were infrequent but occurred more often with RP than SP.
“More research is needed on sustainability, feasibility, and health economic aspects of this intervention. Substantially fewer days used with the RP is cost saving, but the resources needed for more intensive monitoring may outweigh these savings,” the authors noted in the study discussion.
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