Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations
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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DOI：
10.1016/j.cct.2020.106014
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发表时间：
2020-06-01
影响因子：
2.2
通讯作者：
Rosa, Carmen
中科院分区：
文献类型：
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作者：
Winhusen, Theresa;Lofwall, Michelle;Rosa, Carmen
近年来，孕妇中的阿片类药物使用障碍(OUD)显著增加。维持这些妇女的舌下(SL)丁丙诺啡(BUP)是一种循证的做法，但BUP-SL与几个缺点有关，缓释(XR)BUP配方可以消除。国家药物滥用治疗临床试验网络(CTN)正在进行一项意向治疗、双臂、开放标签、务实的随机对照试验，针对阿片类药物依赖的准妈妈进行药物治疗，以比较使用BUD-XR的孕妇和使用BUP-SL的孕妇的母婴结局。第二个目标是确定利用BUP-XR的相对经济价值。从12个地点招募的大约300名估计孕周(EGA)为6-30周的孕妇将按1：1的比例与BUP-XR或BUP-SL随机分组，在随机时平衡现场、EGA和BUP-SL状态(服用/不服用)。参与者将被提供学习药物，并在产后12个月内每周接受药物访问。参与者将被邀请参加两个子研究，以评估：1)BUP-XR可能改善母婴结局的机制；以及2)产前暴露于BUP-XR与BUP-SL对婴儿神经发育的影响。本文描述了在协议开发过程中主要试验的关键设计决策。这项研究新药(IND)试验在可行的情况下独一无二地使用了实用功能，以最大限度地提高外部有效性，从而增加了为临床实践指南提供信息的可能性，并解决了治疗这一患者群体的多种知识差距。
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.