Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): A stepped wedge hybrid type 1 effectiveness-implementation study

Greiner, Miranda; Shulman, Matisyahu; Opara, Onumara; Potter, Kenzie; Voronca, Delia; Tafessu, Hiwot M.; Hefner, Kathryn R.; Hamilton, Amy L.; Scheele, Christina; Ho, Rachel L M; Dresser, Lauren; Jelstrom, Eve; Fishman, Marc; Ghitza, Udi E.; Rotrosen, John; Nunes, Edward V.; Bisaga, Adam

doi:10.1016/j.cct.2023.107148

Cited by 2 publications

(2 citation statements)

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“…SWIFT was approved at all sites by Biomedical Research Alliance of New York, and informed consent was obtained from all participants; financial compensation was provided. Methodologic details of the study were published previously 15 and are available in the Trial Protocol in Supplement 1 . The reported findings follow the Consolidated Standards of Reporting Trials ( CONSORT ) reporting guideline for randomized studies.…”

Section: Methodsmentioning

confidence: 99%

“…SWIFT was approved at all sites by Biomedical Research Alliance of New York, and informed consent was obtained from all participants; financial compensation was provided. Methodologic details of the study were published previously 15 Participants received the initiation procedure (ie, SP or RP) that their program was assigned to at the time of their admission. After the inpatient stay, participants were referred for outpatient addiction treatment according to each site's SPs and were followed up for 8 outpatient weeks; the second and third XR-naltrexone injections were offered at weeks 4 and 8 after the first injection.…”

Section: Methodsmentioning

confidence: 99%

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Rapid Initiation of Injection Naltrexone for Opioid Use Disorder

Shulman,

Greiner,

Tafessu

et al. 2024

JAMA Netw Open

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ImportanceInjectable 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.ObjectiveTo compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation.Design, Setting, and ParticipantsThe 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.InterventionsStandard 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 MeasuresReceipt 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.ResultsA 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 (&gt;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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT04762537

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“…SWIFT was approved at all sites by Biomedical Research Alliance of New York, and informed consent was obtained from all participants; financial compensation was provided. Methodologic details of the study were published previously 15 and are available in the Trial Protocol in Supplement 1 . The reported findings follow the Consolidated Standards of Reporting Trials ( CONSORT ) reporting guideline for randomized studies.…”

Section: Methodsmentioning

confidence: 99%

“…SWIFT was approved at all sites by Biomedical Research Alliance of New York, and informed consent was obtained from all participants; financial compensation was provided. Methodologic details of the study were published previously 15 Participants received the initiation procedure (ie, SP or RP) that their program was assigned to at the time of their admission. After the inpatient stay, participants were referred for outpatient addiction treatment according to each site's SPs and were followed up for 8 outpatient weeks; the second and third XR-naltrexone injections were offered at weeks 4 and 8 after the first injection.…”

Section: Methodsmentioning

confidence: 99%