Evidence map›Paper›PMID 33838307›Full record

ArticleContemporary clinical trials2021

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.

Nikhil Seval, Cynthia A Frank, Alain H Litwin, Prerana Roth, Meredith A Schade, Martina Pavlicova, Frances R Levin, Kathleen T Brady, Edward V Nunes, Sandra A Springer

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% of its field
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  7. Review
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  12. HIV and liver disease: a comprehensive update.Topics in antiviral medicine · 2022
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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

10 authors at 5 institutions in 1 country.

Nikhil SevalYale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA.
Cynthia A FrankYale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA.
Alain H LitwinUniversity of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA; Department of Medicine, University of South Carolina School of Medicine- Greenville, Greenville, SC, USA.
Prerana RothUniversity of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA.
Meredith A SchadePenn State Milton S. Hershey Medical Center, Department of Medicine, Division of Infectious Diseases, Hershey, PA, USA.
Martina PavlicovaColumbia University Mailman School of Public Health, Department of Biostatistics, New York, NY, USA.
Frances R LevinCollege of Physicians and Surgeons of Columbia University, New York State Psychiatric Institute/Division on Substance Use Disorders, New York, NY, USA.
Kathleen T BradyDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Edward V NunesCollege of Physicians and Surgeons of Columbia University, New York State Psychiatric Institute/Division on Substance Use Disorders, New York, NY, USA.
Sandra A SpringerYale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. Electronic address: Sandra.springer@yale.edu.
Columbia University · USMedical University of South Carolina · USPenn State Milton S. Hershey Medical Center · USPrisma Health · USUniversity of South Carolina · US

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Southern Consortium Node of the Clinical Trials Network (Varenicline)UG1DA013727 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI KATHLEEN T. BRADY, Kelly S. Barth · 2015 to 2026
$24.8M
TRAINING IN THE PATHOGENESIS OF INFECTIOUS DISEASEST32AI007517 · NIAID · YALE UNIVERSITY · PI Jaimie Meyer, Albert C Shaw · 1997 to 2026
$6.1M
Coordinated medical treatment of opioid use disorder and infectious diseaseU01TR002763 · NCATS · YALE UNIVERSITY · PI BRADY, KATHLEEN T., LEVIN, FRANCES RUDNICK · 2019 to 2022
$5.4M
Medication Assisted Therapy as a Conduit to Care for HIV+ CJS Populations TransitK02DA032322 · NIDA · YALE UNIVERSITY · PI SPRINGER, SANDRA ANN · 2011 to 2022
$1.3M
NCATS NIH HHS U01 TR002763NCATS NIH HHS UL1 TR001863NIAID NIH HHS T32 AI007517NIDA NIH HHS K02 DA032322NIDA NIH HHS UG1 DA013035NIDA NIH HHS UG1 DA013727
6 · The paper itself

Abstract

backgroundHospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge.

methodsA randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose.

resultsWe describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial.

conclusionsStudy findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.

Indexed as

BuprenorphineDelivery of Health Care, IntegratedOpioid-Related DisordersAdultHumansNeoplasm Recurrence, LocalOpiate Substitution TreatmentRandomized Controlled Trials as TopicBuprenorphineBuprenorphineHospitalInfectious diseaseOpioid use disorderRandomized controlled trial

Identifiers

PMID33838307
PMCPMC8172465
OpenAlexW3142604409

What OpenQuestion holds

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Registered trials

None linked

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.