Fallin-Bennett Amanda, Lofwall Michelle, Waters Teresa, Nuzzo Paul, Barnett Janine, Ducas Letitia, McCubbin Andrea, Chavan Niraj, Blair Lisa, Ashford Kristin
University of Kentucky College of Nursing, Perinatal Research and Wellness Center, Kentucky (KY), USA.
University of Kentucky Department of Behavioral Science & Psychiatry, Center on Drug and Alcohol Research, Kentucky (KY), USA.
Contemp Clin Trials Commun. 2020 Nov 7;20:100657. doi: 10.1016/j.conctc.2020.100657. eCollection 2020 Dec.
Opioid use during pregnancy is a significant public health issue. The standard of care for treating opioid use disorder during pregnancy includes medications for opioid disorder (MOUD). However, tobacco use often goes unaddressed among pregnant women on MOUD. In 2018, our team received a National Institute on Drug Abuse (NIDA) funded R34 to conduct a three year-randomized trial to test the feasibility of a novel tobacco intervention for pregnant women receiving MOUD.
The aims of this study are: (1) to determine the impact of the B-EPIC intervention on maternal tobacco use and stage of change; (2) to determine the impact of B-EPIC on tobacco-related maternal and infant health outcomes including gestational age at birth, birthweight, NAS diagnosis and severity, and number of ear and respiratory infections during the first six months; (3) to compare healthcare utilization and costs incurred by pregnant patients that receive the B-EPIC intervention versus TAU.
We plan to enroll 100 pregnant women on MOUD for this randomized controlled trial (B-EPIC intervention n = 50 and treatment as usual n = 50). A major strength of this study is its wide range of health and economic outcomes assessed on mother, neonate and the infant.
Despite the very high rates of smoking among pregnant women with OUD, there are few tobacco treatment interventions that have been tailored for this high - risk population. The overall goal of this study is to move towards a tobacco treatment standard for pregnant women receiving treatment for OUD.
孕期使用阿片类药物是一个重大的公共卫生问题。孕期治疗阿片类药物使用障碍的护理标准包括使用治疗阿片类药物障碍的药物(MOUD)。然而,接受MOUD治疗的孕妇中的烟草使用问题往往未得到解决。2018年,我们的团队获得了美国国立药物滥用研究所(NIDA)资助的R34项目,以开展一项为期三年的随机试验,测试一种针对接受MOUD治疗的孕妇的新型烟草干预措施的可行性。
本研究的目的是:(1)确定B-EPIC干预对孕妇烟草使用和改变阶段的影响;(2)确定B-EPIC对与烟草相关的母婴健康结局的影响,包括出生时的孕周、出生体重、新生儿戒断综合征(NAS)的诊断和严重程度,以及前六个月内耳部和呼吸道感染的次数;(3)比较接受B-EPIC干预的孕妇与接受常规治疗(TAU)的孕妇的医疗保健利用率和费用。
我们计划为这项随机对照试验招募100名接受MOUD治疗的孕妇(B-EPIC干预组n = 50,常规治疗组n = 50)。本研究的一个主要优势是对母亲、新生儿和婴儿评估了广泛的健康和经济结局。
尽管患有阿片类药物使用障碍的孕妇吸烟率非常高,但针对这一高危人群量身定制的烟草治疗干预措施却很少。本研究的总体目标是朝着为接受阿片类药物使用障碍治疗的孕妇制定烟草治疗标准迈进。