CTN-0097: Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): Improving the Real-World Effectiveness of Injection Naltrexone for Opioid Use Disorder
Adam Bisaga, MD
Lead Investigator
New York State Psychiatric Institute
Division on Substance Abuse
adam.bisaga@nyspi.columbia.edu
Edward V. Nunes, Jr., MD
Lead Investigator
Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute
nunesed@pi.cpmc.columbia.edu
Inpatient programs are important portals for increasing access to treatment. However, most individuals with opioid use disorder are detoxified but not offered medications to prevent relapse. This randomized-controlled trial will examine whether a rapid-transition protocol to inducting extended release naltrexone (XR-NTX) following detoxification yields a higher proportion of patients successfully receiving the first injection of XR-NTX compared to standard detoxification and naltrexone initiation. This study will also assess facilitators and barriers to implementing rapid XR-NTX initiation. The overall goal is to foster widespread adoption of a 5-7-day protocol for initiation of treatment with XR-NTX at Inpatient/Residential programs.
Funded by the NIH HEAL InitiativeSM.
Primary Findings
In this trial, the rapid procedure for 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.
Primary Outcomes Article: Shulman M, et al. Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Network Open 2024;7(5):e249744. [get article]
Related Resources
Node Involvement
Lead Node(s):
All Participating Nodes: