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- Title
Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial.
- Authors
Shulman, Matisyahu; Greiner, Miranda G.; Tafessu, Hiwot M.; Opara, Onumara; Ohrtman, Kaitlyn; Potter, Kenzie; Hefner, Kathryn; Jelstrom, Eve; Rosenthal, Richard N.; Wenzel, Kevin; Fishman, Marc; Rotrosen, John; Ghitza, Udi E.; Nunes, Edward V.; Bisaga, Adam
- Abstract
Key Points: Question: Can the opioid antagonist injectable extended-release (XR)-naltrexone be started in patients with active opioid use disorder (OUD) with a rapid (5-7 days) procedure? Findings: In a 6-site stepped wedge cluster randomized clinical trial that included 415 individuals with OUD, more patients successfully initiated XR-naltrexone using the rapid procedure (62.7%) compared with a standard (12-14 days) procedure (35.8%). The rapid procedure was shown to be both noninferior and superior, but had a higher number of safety events and serious adverse events and required more staff attention. Meaning: The findings of this trial suggest that a rapid approach to withdrawal management should be considered for patients with OUD attempting to start treatment with XR-naltrexone, but more intensive staffing needs may be a barrier to implementation. Importance: Injectable extended-release (XR)-naltrexone is an effective treatment option for opioid use disorder (OUD), but the need to withdraw patients from opioid treatment prior to initiation is a barrier to implementation. Objective: To compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation. Design, Setting, and Participants: The Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone study was an optimized stepped-wedge cluster randomized trial conducted at 6 community-based inpatient addiction treatment units. Units using the SP were randomly assigned at 14-week intervals to implement the RP. Participants admitted with OUD received the procedure the unit was delivering at the time of their admission. Participant recruitment took place between March 16, 2021, and July 18, 2022. The last visit was September 21, 2022. Interventions: Standard procedure, based on the XR-naltrexone package insert (approximately 5-day buprenorphine taper followed by a 7- to 10-day opioid-free period and RP, defined as 1 day of buprenorphine at minimum necessary dose, 1 opioid-free day, and ascending low doses of oral naltrexone and adjunctive medications (eg, clonidine, clonazepam, antiemetics) for opioid withdrawal. Main Outcomes and Measures: Receipt of XR-naltrexone injection prior to inpatient discharge (primary outcome). Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat. Results: A total of 415 participants with OUD were enrolled (mean [SD] age, 33.6 [8.48] years; 205 [49.4%] identified sex as male); 54 [13.0%] individuals identified as Black, 91 [21.9%] as Hispanic, 290 [69.9%] as White, and 22 [5.3%] as multiracial. 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. Conclusions and Relevance: In this trial, the RP of XR-naltrexone initiation was noninferior to the standard approach and saved time, although it required more intensive medical management and safety monitoring. The results of this trial suggest that rapid initiation could make XR-naltrexone a more viable treatment for patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT04762537 This stepped-wedge cluster trial evaluates the effectiveness of a rapid 5- to 7-day initiation of extended-release naltrexone compared with the standard 12- to 14-day procedure among individuals with opioid use disorder.
- Subjects
SUBSTANCE abuse; STATISTICAL sampling; TREATMENT effectiveness; RANDOMIZED controlled trials; DESCRIPTIVE statistics; ODDS ratio; NARCOTICS; COMPARATIVE studies; CONFIDENCE intervals; NALTREXONE
- Publication
JAMA Network Open, 2024, Vol 7, Issue 1, pe249744
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.9744