Evidence map›Paper›PMID 40645369›Full record

ArticleContemporary clinical trials2025

Injectable buprenorphine during transition out of prison: A pilot partially randomized preference trial protocol.

Justin Berk, Max Cook, Megan Martin, Joshua D Lee, Daphne Koinis-Mitchell, Lauren Brinkley-Rubinstein, Mari-Lynn Drainoni, Josiah Rich

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Justin BerkAlpert Medical School at Brown University; Providence, RI 02905, United States of America. Electronic address: justin_berk@brown.edu.
Max CookTufts University; Department of Psychology; Medford, MA 02155, United States of America.
Megan MartinAlpert Medical School at Brown University; Providence, RI 02905, United States of America.
Joshua D LeeNew York University Grossman School of Medicine; Departments of Population Health and Medicine; New York, NY 11016, United States of America.
Daphne Koinis-MitchellAlpert Medical School at Brown University; Providence, RI 02905, United States of America.
Lauren Brinkley-RubinsteinDuke University; Department of Population Health Sciences, United States of America.
Mari-Lynn DrainoniSection of Infectious Diseases, Department of Medicine, Boston Medical Center & Boston University Chobanian & Avedisian School of Medicine, United States of America; Department of Health Law Policy & Management, Boston University School of Public Health, United States of America; Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University Chobanian & Avedisian School of Medicine, United States of America.
Josiah RichAlpert Medical School at Brown University; Providence, RI 02905, United States of America.

Funding

Science CoreP2CHD065563 · NICHD · DUKE UNIVERSITY · PI James Moody · 2015 to 2026
$5.7M
Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: A Pilot Randomized Controlled TrialK23DA055695 · NIDA · RHODE ISLAND HOSPITAL · PI Justin Berk · 2022 to 2026
$1.0M
NICHD NIH HHS P2C HD065563NIDA NIH HHS K23 DA055695
6 · The paper itself

Abstract

backgroundIndividuals involved in the criminal legal system represent one of the most disproportionately affected populations in the opioid overdose crisis. Despite evidence of medications for opioid use disorder (MOUD) reducing overdose mortality, illicit opioid use, and recidivism, most correctional facilities do not offer these treatments. Sublocade and Brixadi, two distinct, branded, formulations of extended-release buprenorphine (XR-B), offer a promising approach to improving MOUD treatment adherence and reducing post-release overdose deaths.

methodsThis hybrid pilot study will utilize a partially randomized preference trial (PRPT) design to compare the preliminary effectiveness, feasibility, acceptability and other outcomes between Sublocade and Brixadi initiation. We aim to enroll 60 incarcerated individuals with opioid use disorder who are interested in XR-B and have a scheduled release within 120 days. Participants will choose their preferred injectable treatment or, if ambivalent, be randomly assigned. All participants will receive monthly XR-B injections pre-release and continue for three months post-release, with additional administrative follow-up for another three months. The primary outcome is post-release treatment retention; other outcomes will be assessed using the Proctor taxonomy. Data will be collected using clinical assessments, surveys, and administrative databases. DISCUSSION: This study explores differences in XR-B formulations during the high-risk time of transition out of prison. It combines a hybrid implementation science and preference trial design-two methodologies that can help address the specific challenges of research in carceral environments. By understanding implementation of XR-B in a prison setting, findings can provide valuable insights to guide other facilities in adopting this life-saving treatment.

Indexed as

BuprenorphineNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPrisonersAdultDelayed-Action PreparationsFemaleHumansMaleMedication AdherencePilot ProjectsPrisonsRandomized Controlled Trials as TopicBuprenorphineDelayed-Action PreparationsNarcotic AntagonistsCriminal justice systemExtended-release buprenorphineOpioid use disorderPartially randomized preference trialPrison

Identifiers

PMID40645369
PMCPMC12900163

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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.