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

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

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations
Creator	Murphy, Sean Greenfield, Shelly Guille, Connie Jones, Hendrée Kropp, Frankie Lewis, Mitra Lindblad, Robert Lofwall, Michelle Matthews, Abigail Merhar, Stephanie Rosa, Carmen Schiff, Davida Silverstein, Michael Terplan, Mishka Theobald, Jeff Wachman, Elisha Wexelblatt, Scott Wilder, Christine Winhusen, Theresa
source	Elsevier; Medline; PMC
abstract	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.
has issue date	2020-04-27(xsd:dateTime)
bibo:doi	10.1016/j.cct.2020.106014
bibo:pmid	32353544
has license	els-covid
sha1sum (hex)	f9cbfa0038f5a26e987a18e29f7e54ac177f5a0b
schema:url	https://doi.org/10.1016/j.cct.2020.106014
resource representing a document's title	Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations
has PubMed Central identifier	PMC7184985
has PubMed identifier	32353544
schema:publication	Contemp Clin Trials
resource representing a document's body	covid:f9cbfa0038f5a26e987a18e29f7e54ac177f5a0b#body_text
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