Evidence map›Paper›PMID 38857827›Full record

Trial reportJournal of substance use and addiction treatment2024

Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial.

Dylan Rose Balter, Lisa B Puglisi, James Dziura, David A Fiellin, Benjamin A Howell

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in Journal of substance use and addiction treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Dylan Rose BalterYale School of Medicine, New Haven, CT, United States of America.
Lisa B PuglisiSEICHE Center for Health and Justice, Yale School of Medicine, New Haven, CT, United States of America; Section of General Medicine, Yale School of Medicine, New Haven, CT, United States of America; Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, United States of America.
James DziuraDepartment of Emergency Medicine, Yale School of Medicine, New Haven, CT, United States of America.
David A FiellinSection of General Medicine, Yale School of Medicine, New Haven, CT, United States of America; Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, United States of America; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, United States of America.
Benjamin A HowellSEICHE Center for Health and Justice, Yale School of Medicine, New Haven, CT, United States of America; Section of General Medicine, Yale School of Medicine, New Haven, CT, United States of America; Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, United States of America.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Drug use, Addiction and HIV Research Scholars (DAHRS)K12DA033312 · NIDA · YALE UNIVERSITY · PI Gail D'Onofrio, Patrick O'Connor · 2013 to 2026
$7.2M
NIAAA Short-Term Training: Students in Health Professional SchoolsT35AA023760 · NIAAA · YALE UNIVERSITY · PI HERZOG, ERICA L, KRYSTAL, JOHN H. · 2017 to 2021
$314k
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS T35 AA023760NIDA NIH HHS K12 DA033312
6 · The paper itself

Abstract

introductionThere is uncertainty about whether criminal legal involvement (CLI) impacts the effectiveness of medications for opioid use disorder (MOUD). We aimed to determine whether CLI modifies the association between buprenorphine-naloxone (BUP-NX) vs. extended-release naltrexone (XR-NTX) and MOUD treatment outcomes.

methodsWe conducted a secondary analysis of X:BOT, a 24-week multi-center randomized controlled trial comparing treatment outcomes between BUP-NX (n = 287) and XR-NTX (n = 283) in the general population. We used baseline Additional Severity-Index Lite responses to identify patients with recent CLI (n = 342), defined as active CLI and/or CLI in the past 30 days, and lifetime incarceration (n = 328). We explored recent CLI and lifetime incarceration as potential effect modifiers of BUP-NX vs. XR-NTX effectiveness on relapse, induction, and overdose. We conducted both intention-to-treat and per-protocol analyses for each outcome.

resultsIn intention-to-treat analyses, recent CLI modified the effect of BUP-NX vs. XR-NTX on odds of successful induction (p = 0.03) and hazard of overdose (p = 0.04), but it did not modify the effect on hazard of relapse (p = 0.23). All participants experienced lower odds of successful induction with XR-NTX compared to BUP-NX, but the relative likelihood of successful induction with BUP-NX was lower than XR-NTX among individuals with recent CLI (OR: 0.25, 95 % CI: 0.13-0.47, p < 0.001) compared to those without recent CLI (OR: 0.04, 95 % CI: 0.01-0.19, p < 0.001). Participants with recent CLI experienced similar hazard of overdose with XR-NTX and BUP-NX (HR: 1.12, 95 % CI: 0.42-3.01, p = 0.82), whereas those without recent CLI experienced greater hazard of overdose with XR-NTX compared to BUP-NX (HR: 12.60, 95 % CI: 1.62-98.03, p = 0.02). In per-protocol analyses, recent CLI did not modify the effect of MOUD on hazard of overdose (p = 0.10) or relapse (p = 0.41). Lifetime incarceration did not modify any outcome.

conclusionsCompared to individuals without recent CLI, individuals with recent CLI experienced decreased relative effectiveness of BUP-NX compared to XR-NTX for induction and overdose outcomes. This highlights the importance of considering the impact of recent CLI on opioid use disorder treatment outcomes. Future research should explore the mechanisms through which recent CLI modifies MOUD effectiveness and aim to improve MOUD effectiveness for individuals with recent CLI.

Indexed as

Buprenorphine, Naloxone Drug CombinationDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsOpioid-Related DisordersAdultCriminalsDrug OverdoseFemaleHumansMaleMiddle AgedOpiate Substitution TreatmentRecurrenceTreatment OutcomeBuprenorphine, Naloxone Drug CombinationDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsAddiction treatmentCriminal legal involvementIncarcerationOpioid use disorder

Identifiers

PMID38857827
PMCPMC11300157

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.