Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco use among Opioid Addicted Women

摘要： 每年，美国有225，000名婴儿在产前接触非法药物。使用药物的妇女 疾病，特别是那些阿片类药物依赖，是非常容易受到吸烟在围产期 期寻求药物辅助治疗（MAT）的妊娠阿片类药物依赖患者吸烟率高， 从88%到95%。怀孕期间吸烟是一个独立的风险因素（非法药物使用以外）， 不良后果包括宫外孕、早产、口面裂和婴儿猝死综合征。非法 阿片类药物的使用放大了这些风险;在怀孕期间使用阿片类药物的妇女中， 胎儿宫内生长受限，妊娠晚期阴道出血，早产，大多数也会经历 新生儿戒断综合征（NAS）。产前烟草使用显著增加了NAS的严重程度和持续时间， 在接受MAT的阿片类药物依赖孕妇中不常接受治疗。平均而言，每个人的医疗保健费用 NAS出院婴儿的费用从39，400美元到53，400美元不等; 77.6%由医疗补助支付。MAT已被证明 与未治疗相比，降低NAS的严重程度;然而，MAT中的大多数阿片类药物依赖女性仍然继续 在整个怀孕期间吸烟，这清楚地表明，有一个全面的，证据， 烟草治疗干预。到目前为止，还没有具体的药理学或非药理学烟草- MAT中阿片类药物依赖孕妇的治疗标准。需要更多的研究来开发和测试定制的 对孕妇和阿片类药物依赖妇女的烟草治疗干预。这次审判的目的是为了测试一部小说 戒烟干预，行为和加强围产期戒烟干预（B-EPIC），在一个 建立社区MAT诊所。B-EPIC旨在降低烟草相关的发病率（例如，早产， NAS）和接受丁丙诺啡作为阿片类药物的烟草使用者孕妇的医疗保健支出 依赖这项两组随机对照临床试验（n =100）将提供关键的初步数据， 更大规模的试验。由于几乎所有的B-EPIC服务都是通过公共和私人保险公司付费的服务， 可持续性的可能性。

ABSTRACT: Each year, 225,000 infants in the United States are exposed prenatally to illicit drugs. Women with substance use disorders, particularly those with opioid dependence, are highly vulnerable to cigarette smoking during the perinatal period. Pregnant opioid dependent patients seeking medication-assisted treatment (MAT) have high rates of smoking, ranging from 88% to 95%. Smoking during pregnancy is an independent risk factor (outside of illicit drug use) for several adverse outcomes including ectopic pregnancy, premature birth, orofacial clefts, and sudden infant death syndrome. Illicit opioid use magnifies these risks; among women who use opioids during pregnancy, there is a 6-fold greater risk for intrauterine growth restriction, third trimester vaginal bleeding, preterm delivery, and a majority also will experience neonatal abstinence syndrome (NAS). Prenatal tobacco use significantly increases the severity and duration of NAS, yet is not commonly treated among opioid dependent pregnant women receiving MAT. On average, the healthcare cost per discharged infant with NAS ranges from $39,400 to $53,400; and 77.6% is paid for by Medicaid. MAT has been shown to decrease the severity of NAS compared to no treatment; yet, most opioid dependent women in MAT still continue to smoke cigarettes throughout pregnancy, clearly suggesting that there is a significant need for a comprehensive, evidence- based tobacco treatment intervention. To date, there is no specific pharmacologic or non-pharmacologic tobacco- treatment standard for opioid dependent pregnant women in MAT. More research is needed to develop and test tailored tobacco treatment interventions for pregnant, opioid dependent women. The purpose of this trial is to test a novel intervention for tobacco cessation, Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC), in an established community MAT clinic. B-EPIC is designed to reduce tobacco-associated morbidity (e.g., preterm birth, NAS) and healthcare expenditures in pregnant women who are tobacco users receiving buprenorphine for opioid dependence. This two-group randomized and controlled clinical trial (n =100) will provide critical preliminary data to test larger-scale trials. As nearly all B-EPIC services are billable services via public and private insurers; there is high likelihood for sustainability.