CTN-0097: Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone: Improving the Real-World Effectiveness of Injection Naltrexone for Opioid Use Disorder (SWIFT)
Investigator: Adam Bisaga, M.D.
Release Date: TBA
Objective: The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid method of initiating treatment with extended-release injection naltrexone (XR-NTX) is non-inferior to a standard method on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection) when implemented at community-based inpatient or residential programs.
Significance/Impact: This study will be to foster widespread adoption of a protocol for rapid initiation of treatment with XR-NTX at inpatient or residential Community Treatment Programs (CTPs). If widely adopted, such a protocol would have a substantial public health impact by expanding medication treatment options offered to patients with OUD to include XR-NTX.
Study Design/Methodology: The proposed study is an open-label, multi-center, stepped-wedge cluster randomized trial. It will be conducted in 6 CTN-affiliated CTPs that are able to provide inpatient or residential detoxification services and have the capacity for an ongoing outpatient treatment with XR-NTX.
As part of the stepped-wedge design proposed for this trial, one site, randomly chosen, will start implementing the Rapid protocol procedure and will remain in this arm for the rest of the study, the next 4 sites randomly chosen will first implement the control procedure (Standard, 13-day procedure; SP), to establish the within-site comparison condition, and then at selected staggered time-points (steps) will switch to implementing only the experimental (Rapid, 5-7-day procedure; RP), and the 6th site (after 5 sites have been randomized to RP) will remain in the SP protocol arm throughout the whole duration of the study. Implementation of RP at study sites will be staggered by 14 weeks and the order in which sites will cross-over from SP to RP will be randomly chosen.
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