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Randomized Controlled Trial
. 2025 May 1;8(5):e2513000.
doi: 10.1001/jamanetworkopen.2025.13000.

Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial

Nikhil Seval  1 , Prerana Roth  2   3 , Cynthia A Frank  4 , Angela Di Paola  4 , Alain H Litwin  2   3 , Brent Vander Wyk  4 , Victor Neirinckx  4 , Esther Schlossberg  4 , Patrick Lawson  2 , Michelle Strong  2 , Meredith A Schade  5 , Jonathan Nunez  5 , Frances R Levin  6   7 , Kathleen T Brady  8 , Edward V Nunes  6   7 , Sandra A Springer  4
Affiliations
Randomized Controlled Trial

Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial

Nikhil Seval et al. JAMA Netw Open. .

Abstract

Importance: Hospitalizations are increasing in the US due to infections related to opioid use disorder (OUD); however, few patients have treatment with medications for OUD (MOUD) initiated. Injectable long-acting buprenorphine (LAB) could help improve MOUD receipt and infection treatment completion.

Objective: To compare initiation of LAB combined with infectious disease (ID) management (ID-LAB) with treatment as usual (TAU) during inpatient medical hospitalization periods for improving receipt of MOUD at 12 weeks.

Design, setting, and participants: The Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (COMMIT) trial was a multisite randomized clinical trial with enrollment from August 19, 2020, through October 31, 2023, at 3 US hospital systems in Connecticut, Pennsylvania, and South Carolina. Eligible participants were individuals hospitalized with a diagnosis of moderate to severe OUD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) and concurrent infection. Intent-to-treat outcomes were assessed at the end of the 12-week intervention period.

Interventions: Participants were randomized 1:1 to receive ID-LAB or TAU during treatment for infection in a hospital setting or early after discharge. All participants received a nurse care medical management intervention.

Main outcomes and measures: The primary outcome was the proportion of patients who received any form of MOUD at 12 weeks after randomization. Models were adjusted by site, prescription of MOUD in the 30 days prior to hospitalization, and the baseline value of each outcome when assessable.

Results: Of the 171 participants who were enrolled, 86 were randomized to the ID-LAB arm and 85 to the TAU arm. A total of 88 participants (51.5%) were men, and median age was 39 (IQR, 33-47) years. At 12 weeks, there was no statistically significant difference in receipt of MOUD between the ID-LAB and TAU groups, with 51 patients (59.3%) and 46 (54.1%), respectively, receiving MOUD (adjusted rate ratio, 1.01; 95% CI, 0.78-1.30).

Conclusions and relevance: In this randomized clinical trial comparing initiation of LAB for OUD with ID management in the hospital setting compared with TAU, there was no difference between arms in the receipt of MOUD at 12 weeks. The TAU arm had higher retention than anticipated. These findings suggest that hospitalization with an infection related to drug use may present an opportunity to identify OUD and initiate MOUD that may include injectable LAB. The nurse case management services provided to all participants should be evaluated in future studies.

Trial registration: ClinicalTrials.gov Identifier: NCT04180020.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Seval reported receiving grants from the Pennsylvania Department of Health, the Pennsylvania Office of Drug Surveillance and Misuse Prevention, and the Hepatitis B Foundation outside the submitted work. Dr Litwin reported receiving a grant from NCATS during the conduct of the study; receiving grants and personal fees from and serving on the speaker’s bureau for Gilead Sciences outside the submitted work; and receiving personal fees from AbbVie outside the submitted work. Dr Nunez reported receiving grants from NCATS during the conduct of the study. Dr Levin reported receiving personal fees for being a consultant for Major League Baseball; receiving grants from NCATS, the Substance Abuse and Mental Health Services Administration, US WorldMeds, and the National Institute on Drug Abuse; and receiving research support from AELIS Pharmaceutical outside the submitted work and reported receiving royalties from the APA and Oxford University Press; serving without pay on advisory boards for atai Life Sciences, Boehringer Ingelheim, and Indivior; and serving on NCATS. Dr Nunes reported being an Indivior principal investigator on an NIH-funded study that received in-kind donation of medication (Suboxone) from Indivior and serving as a consultant for Indivior without compensation during the conduct of the study and being an Alkermes investigator on an NIH-funded study that received in-kind donation of medication from Alkermes, being a Braeburn investigator on an NIH-funded study that received in-kind donation of medication from Braeburn, being a Camurus investigator on an NIH-funded study that received in-kind donation of medication from Camurus, being a CHESS Health investigator on an NIH-funded study that received in-kind donation of a digital therapeutic from CHESS Health, being a Pear Therapeutics investigator on an NIH-funded study that received in-kind donation of a digital therapeutic from Pear Therapeutics, and serving as a consultant for Camurus without compensation outside the submitted work. Dr Springer reported receiving grants from the NIH during the conduct of the study, receiving paid honoraria from Alkermes Inc for scientific consultation outside the submitted work, and receiving in-kind study drug donations from Indivior and Alkermes for NIH-sponsored research. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
ID indicates infectious disease; ITT, intent to treat; LAB, long-acting buprenorphine; MOUD, medications for opioid use disorder; OUD, opioid use disorder; TAU, treatment as usual.
Figure 2.
Figure 2.. Interview and Study Medication Injection Retention
Details on interview retention are given in eTable 3 in Supplement 2.
See this image and copyright information in PMC

Comment in

  • doi: 10.1001/jamanetworkopen.2025.13010

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