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

BACKGROUND

Extended-release injectable naltrexone (XR-NTX) is an effective treatment for opioid use disorder (OUD), but initiation remains a barrier to implementation. Standard practice requires a 10- to 15-day inpatient admission prior to XR-NTX initiation and involves a methadone or buprenorphine taper followed by a 7- to 10-day washout, as recommended in the Prescribing Information for XR-NTX. A 5- to 7-day rapid induction approach was developed that utilizes low-dose oral naltrexone and non-opioid medications.

METHODS

The CTN-0097 Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT) study was a hybrid type I effectiveness-implementation trial that compared the effectiveness of the standard procedure (SP) to the rapid procedure (RP) for XR-NTX initiation across six community inpatient addiction treatment units, and evaluated the implementation process. Sites were randomized to RP every 14 weeks in an optimized stepped wedge design. Participants (target recruitment = 450) received the procedure (SP or RP) that the site was implementing at time of admission. The hypothesis was RP will be non-inferior to SP on proportion of inpatients who receive XR-NTX, with a shorter admission time for RP. Superiority testing of RP was planned if the null hypothesis of inferiority of RP to SP was rejected.

DISCUSSION

If RP for XR-NTX initiation is shown to be effective, the shorter inpatient stay could make XR-NTX more feasible and have an important public health impact expanding access to OUD pharmacotherapy. Further, a better understanding of facilitators and barriers to RP implementation can help with future translatability and uptake to other community programs.

TRIAL REGISTRATION

NCT04762537 Registered February 21, 2021.

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Adam Bisaga has participated as an unpaid consultant to Alkermes, Inc., received grant funding (through the institution) from Alkermes, Inc., has served as an investigator on a multi-site clinical trial funded by Alkermes, Inc., and has received medication for NIDA-funded studies from Alkermes, Inc. Dr. Edward V. Nunes has been a Principal Investigator or Co-Investigator on studies that received donated or discounted medication from Alkermes, Inc., Indivior Inc. (formerly Reckitt-Benckiser) and Braeburn-Camurus, Inc. (CAM-2038), and donated digital therapeutic from Pear Therapeutics and CHESS Health. Dr. Nunes has served as an uncompensated consultant to Alkermes, Inc., Braeburn-Camurus Inc., Indivior, and Pear Therapeutics. He has no relevant equity, intellectual property, compensated consulting, travel, or other arrangements with any of these entities. Dr. John Rotrosen has been a Principal Investigator or a Co-Investigator on studies for which support in the form of donated or discounted medication, smartphone apps, and/or funds has been, or is provided by Alkermes, Inc. (Vivitrol®, extended-release injectable naltrexone), Indivior, Inc. (formerly Reckitt-Benckiser; Suboxone®, buprenorphine/naloxone combination), Braeburn-Camurus, Inc. (extended-release injectable buprenorphine), Pear Therapeutics (smartphone apps ReSET and ReSET-O), CHESS Health (Connections smartphone app), and Data Cubed (smartphone apps SOAR and mSAPPORT). None of this support has gone, or will go, directly to Dr. Rotrosen, rather to either NYU, or to NIDA/NIH, or to NIDA's contractor Emmes, Inc. Dr. Rotrosen recently served in a non-paid capacity as a member of an Alkermes, Inc. study Steering Committee. He has no relevant equity, intellectual property, compensated consulting, travel or other arrangements with any of these entities. Dr. Marc Fishman has served as a consultant for Alkermes, Inc. and Drug Delivery LLC, and an investigator on a study funded by Alkermes, Inc. The remaining authors have no conflicts of interest to report.