TY - JOUR
T1 - Medication treatment for opioid use disorder in expectant mothers (MOMs)
T2 - Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations
AU - Winhusen, Theresa
AU - Lofwall, Michelle
AU - Jones, Hendrée E.
AU - Wilder, Christine
AU - Lindblad, Robert
AU - Schiff, Davida M.
AU - Wexelblatt, Scott
AU - Merhar, Stephanie
AU - Murphy, Sean M.
AU - Greenfield, Shelly F.
AU - Terplan, Mishka
AU - Wachman, Elisha M.
AU - Kropp, Frankie
AU - Theobald, Jeff
AU - Lewis, Mitra
AU - Matthews, Abigail G.
AU - Guille, Connie
AU - Silverstein, Michael
AU - Rosa, Carmen
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/6
Y1 - 2020/6
N2 - 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.
AB - 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.
KW - Buprenorphine
KW - Extended-release
KW - Infant
KW - Neurodevelopment
KW - Opioid
KW - Pregnant
UR - http://www.scopus.com/inward/record.url?scp=85084196720&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85084196720&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106014
DO - 10.1016/j.cct.2020.106014
M3 - Article
C2 - 32353544
AN - SCOPUS:85084196720
SN - 1551-7144
VL - 93
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106014
ER -