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 language | English |
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Article number | 106014 |
Journal | Contemporary Clinical Trials |
Volume | 93 |
DOIs | |
State | Published - Jun 2020 |
Bibliographical note
Funding Information:This work was supported by the National Institute on Drug Abuse , United States of America, National Drug Abuse Treatment Clinical Trials Network , National Institutes of Health , by grants: UG1DA013732 to the University of Cincinnati (Theresa Winhusen), UG1DA015831 (Roger Weiss and Kathleen Carroll), UG1DA015815 (James Sorensen and Todd Korthuis), UG1DA013720 (Jose Szapocznik, Daniel Feaster, and Lisa Metsch), UG1DA013727 (Kathleen Brady and Matthew Carpenter), UG1DA049436 (Jane Liebschutz and Judith Feinberg), UG1DA013714 (Dennis Donovan and Mary Hatch-Maillette), UG1DA049468 (Kimberly Page), UG1DA049444 (Adam Gordon, Gerald Cochran, and Jon-Kar Zubieta), UG1DA040317 (Li-Tzy Wu). The work was also supported by NIDA contracts to the Clinical Trials Network Clinical Coordinating Center (CCC) (HHSN271201500065C) and Clinical Trials Network Data and Statistics Center (DSC) (HHSN271201400028C). The Publications Committee of the National Drug Abuse Treatment Clinical Trials Network reviewed and gave approval for submission of this manuscript.
Funding Information:
This work was supported by the National Institute on Drug Abuse, United States of America, National Drug Abuse Treatment Clinical Trials Network, National Institutes of Health, by grants: UG1DA013732 to the University of Cincinnati (Theresa Winhusen), UG1DA015831 (Roger Weiss and Kathleen Carroll), UG1DA015815 (James Sorensen and Todd Korthuis), UG1DA013720 (Jose Szapocznik, Daniel Feaster, and Lisa Metsch), UG1DA013727 (Kathleen Brady and Matthew Carpenter), UG1DA049436 (Jane Liebschutz and Judith Feinberg), UG1DA013714 (Dennis Donovan and Mary Hatch-Maillette), UG1DA049468 (Kimberly Page), UG1DA049444 (Adam Gordon, Gerald Cochran, and Jon-Kar Zubieta), UG1DA040317 (Li-Tzy Wu). The work was also supported by NIDA contracts to the Clinical Trials Network Clinical Coordinating Center (CCC) (HHSN271201500065C) and Clinical Trials Network Data and Statistics Center (DSC) (HHSN271201400028C). The Publications Committee of the National Drug Abuse Treatment Clinical Trials Network reviewed and gave approval for submission of this manuscript.
Publisher Copyright:
© 2020 Elsevier Inc.
Keywords
- Buprenorphine
- Extended-release
- Infant
- Neurodevelopment
- Opioid
- Pregnant
ASJC Scopus subject areas
- Pharmacology (medical)