SWIFT
Trial question
What is the role of rapid initiation procedure of injectable naltrexone extended-release in patients with opioid use disorder?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 415
415 patients (210 female, 205 male).
Inclusion criteria: patients admitted with opioid use disorder.
Key exclusion criteria: disabling or terminal medical illness; severe untreated or inadequately treated mental disorder; maintenance treatment with methadone; presence of pain of sufficient severity to require ongoing pain management with opioids; incarceration; pregnancy.
Interventions
N=225 rapid initiation (oral buprenorphine on day 1, followed by one opioid-free day, then oral naltrexone titration plus adjunctive medications for 3-4 days).
N=190 standard procedure (oral buprenorphine taper for 3-5 days, followed by a opioid-free period of 7-10 days).
Primary outcome
Successful initiation of extended-release injectable naltrexone
62.7%
35.8%
62.7 %
47.0 %
31.4 %
15.7 %
0.0 %
Rapid
initiation
Standard
procedure
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in successful initiation of extended-release injectable naltrexone (62.7% vs. 35.8%; OR 3.6, 95% CI 2.12 to 6.1).
Secondary outcomes
No significant difference in second extended-release injectable naltrexone (31.7% vs. 21.3%; AD 10.4%, 95% CI -2.36 to 23.16).
Safety outcomes
No significant differences in targeted safety events, serious adverse events.
Significant difference in acute psychiatric symptoms (3.6% vs. 0%).
Conclusion
In patients admitted with opioid use disorder, rapid initiation was noninferior to standard procedure with respect to successful initiation of extended-release injectable naltrexone.
Reference
Matisyahu Shulman, Miranda G Greiner, Hiwot M Tafessu et al. Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249744.
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