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, Mishka Terplan, Elisha M. Wachman, Frankie Kropp, Jeff Theobald, Mitra Lewis, Abigail G. Matthews, Connie Guille, Michael Silverstein, Carmen Rosa

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

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.

Original languageEnglish
Article number106014
JournalContemporary Clinical Trials
Volume93
DOIs
StatePublished - Jun 2020

Bibliographical note

Publisher Copyright:
© 2020 Elsevier Inc.

Keywords

  • Buprenorphine
  • Extended-release
  • Infant
  • Neurodevelopment
  • Opioid
  • Pregnant

ASJC Scopus subject areas

  • Pharmacology (medical)

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