Evidence map›Paper›PMID 32353544›Full record

ArticleContemporary clinical trials2020

Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.

Theresa Winhusen, Michelle Lofwall, Hendrée E Jones, Christine Wilder, Robert Lindblad, Davida M Schiff, Scott Wexelblatt, Stephanie Merhar, Sean M Murphy, Shelly F Greenfield and 9 more

Open access · greenAbstract readClinical Trial ProtocolMulticenter Study
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
5.6field-weighted citation impact, top 4% 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

20 citing papers in PubMed, 36 citations in OpenAlex.

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  18. Neonatal opioid withdrawal syndrome: a review of the science and a look toward the use of buprenorphine for affected infants.Journal of perinatology : official journal of the California Perinatal Association · 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

19 authors at 11 institutions in 1 country.

Theresa WinhusenDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.
Michelle LofwallDepartments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.
Hendrée E JonesUNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.
Christine WilderDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.
Robert LindbladThe Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.
Davida M SchiffDivision of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.
Scott WexelblattPerinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.
Stephanie MerharPerinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.
Sean M MurphyDepartment of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.
Shelly F GreenfieldDepartment of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.
Mishka TerplanFriends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.
Elisha M WachmanDepartment of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.
Frankie KroppDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.
Jeff TheobaldDepartment of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.
Mitra LewisThe Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.
Abigail G MatthewsThe Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.
Connie GuilleDepartment of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.
Michael SilversteinDepartment of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.
Carmen RosaCenter for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.
University of Cincinnati Medical Center · USEmmes (United States) · USBoston Medical Center · USCincinnati Children's Hospital Medical Center · USCornell University · USFriends Research Institute · USHarvard University · USMaineGeneral Medical Center · USMedical University of South Carolina · USNational Institute on Drug Abuse · USUniversity of Kentucky · US

Funding

The National Drug Abuse Treatment Clinical Trials NetworkUG1DA015831 · NIDA · YALE UNIVERSITY · PI Gail D'Onofrio, Roger D. Weiss · 2015 to 2026
$110.8M
The Florida Node Alliance of the National Drug Abuse Treatment Clinical Trials NetworkUG1DA013720 · NIDA · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI Daniel J Feaster, Viviana Elizabeth Horigian · 2015 to 2026
$50.6M
Clinical Trials Network, Ohio Valley Node U10DA013732U10DA013732 · NIDA · UNIVERSITY OF CINCINNATI · PI WINHUSEN, T JOHN · 2000 to 2015
$45.0M
The Ohio Valley Node of the Clinical Trials Network (CTN-0153)UG1DA013732 · NIDA · UNIVERSITY OF CINCINNATI · PI T John WINHUSEN · 2015 to 2026
$42.5M
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
Western States Node of the National Drug Abuse Treatment Clinical Trials Network (TMS for CUD) UG1DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Keith N. Humphreys, Philip Todd Korthuis · 2015 to 2026
$24.6M
Clinical Trials Network: Pacific Northwest Node (CTN-0082, -0131, -0139 and dissemination library)UG1DA013714 · NIDA · UNIVERSITY OF WASHINGTON · PI Mary Akiko Hatch, John M. Roll · 2015 to 2026
$19.8M
Greater Intermountain Node (CTN-0151)UG1DA049444 · NIDA · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Gerald T. Cochran, Gerald T. Cochran · 2019 to 2026
$16.8M
Southwest Clinical Trials Node: Clinical Research and Practice to Address Substance Use in Diverse, Rural, and Underserved PopulationsUG1DA049468 · NIDA · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI MARIA ADELA GRANDO, Kimberly Page · 2019 to 2026
$12.5M
Project-008UG1DA049436 · NIDA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jane M. Liebschutz, Erin L Winstanley · 2019 to 2026
$10.5M
Project-003UG1DA040317 · NIDA · DUKE UNIVERSITY · PI WU, LI-TZY · 2015 to 2019
$9.0M
Career Development Program in Substance Use and Addiction MedicineK12DA043490 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI A EDEN EVINS, NANCY A RIGOTTI · 2017 to 2026
$4.7M
NIDA NIH HHS HHSN271201400028CNIDA NIH HHS HHSN271201500065CNIDA NIH HHS K12 DA043490NIDA NIH HHS U10 DA013732NIDA NIH HHS UG1 DA013714NIDA NIH HHS UG1 DA013720NIDA NIH HHS UG1 DA013727NIDA NIH HHS UG1 DA013732NIDA NIH HHS UG1 DA015815NIDA NIH HHS UG1 DA015831NIDA NIH HHS UG1 DA040317NIDA NIH HHS UG1 DA049436NIDA NIH HHS UG1 DA049444NIDA NIH HHS UG1 DA049468
6 · The paper itself

Abstract

Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.

Indexed as

Administration, SublingualBuprenorphineDelayed-Action PreparationsFemaleHumansNarcotic AntagonistsOpioid-Related DisordersPragmatic Clinical Trials as TopicPregnancyResearch DesignBuprenorphineDelayed-Action PreparationsNarcotic AntagonistsBuprenorphineExtended-releaseInfantNeurodevelopmentOpioidPregnant

Identifiers

PMID32353544
PMCPMC7184985
OpenAlexW3020278298

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.