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

行为和强化围产期戒烟干预 (B-EPIC)：减少阿片类药物成瘾女性的烟草使用

基本信息

批准号：
9510661
负责人：
Kristin H. Ashford
金额：
$ 22.95万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2021-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9510661
关键词：
Accident and Emergency department Address Adoption Behavior Behavioral Birth Buprenorphine Child Childhood Cigarette Clinic Communities Control Groups Cotinine Counseling DSM-IV Data Diagnosis Ectopic Pregnancy Emergency department visit Epidemic Expenditure Feedback Fetal Growth Retardation Frequencies Gestational Age Goals Health Health Care Costs Health Expenditures Hemorrhage Hospitalization Illicit Drugs Infant Insurance Carriers Intervention Length Length of Stay Medicaid Medical Medical Records Morbidity - disease rate Morphine Neonatal Abstinence Syndrome Neonatal Intensive Care Units Opiate Addiction Opioid Outcome Outpatients Participant Patients Perinatal Pharmacology Pharmacotherapy Postpartum Women Pregnancy Pregnant Women Premature Birth Privatization Randomized Controlled Clinical Trials Readiness Research Respiratory Tract Infections Risk Risk Factors Services Severities Smoke Smoking Substance Use Disorder Sudden infant death syndrome Surveys Testing Third Pregnancy Trimester Time Tobacco Tobacco Dependence Tobacco use United States Urine Vagina Visit Woman adverse outcome biomarker validation cigarette smoke cigarette smoking cost cost-effectiveness ratio design ear infection effectiveness research evidence base experience health care service utilization hospital readmission illicit drug use illicit opioid incremental cost-effectiveness infant outcome maternal tobacco use medication-assisted treatment novel opioid use opioid use in pregnancy orofacial cleft perinatal intervention perinatal period pregnant prenatal prenatal exposure reduce tobacco use smoking cessation smoking during pregnancy standard care tobacco cessation intervention tobacco user treatment as usual

项目摘要

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.

抽象的：美国每年有 225,000 名婴儿在产前接触非法药物。有药物滥用的女性疾病，特别是那些阿片类药物依赖的疾病，在围产期很容易受到吸烟的影响时期。寻求药物辅助治疗 (MAT) 的怀孕阿片类药物依赖患者吸烟率很高，范围从 88% 到 95%。对于一些人来说，怀孕期间吸烟是一个独立的危险因素（非法药物使用除外）。不良后果包括宫外孕、早产、口颌裂和婴儿猝死综合症。非法的阿片类药物的使用会放大这些风险；在怀孕期间使用阿片类药物的女性中，罹患阿片类药物的风险增加 6 倍宫内生长受限、妊娠晚期阴道出血、早产，大多数人也会经历新生儿戒断综合症（NAS）。产前吸烟会显着增加 NAS 的严重程度和持续时间，但在接受 MAT 的阿片类药物依赖孕妇中，这种情况并不常见。平均而言，每人的医疗费用患有 NAS 的出院婴儿的费用从 39,400 美元到 53,400 美元不等； 77.6% 由医疗补助支付。 MAT 已被证明可以与不治疗相比，降低 NAS 的严重程度；然而，大多数 MAT 中的阿片类药物依赖女性仍然继续在整个怀孕期间吸烟，清楚地表明非常需要全面的证据- 基于烟草治疗的干预。迄今为止，还没有特定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针对怀孕、阿片类药物依赖的妇女的烟草治疗干预措施。这次试验的目的是测试一部小说戒烟干预措施，行为和强化围产期戒烟干预措施 (B-EPIC)，建立社区MAT诊所。 B-EPIC 旨在减少与烟草相关的发病率（例如早产、 NAS）和接受丁丙诺啡治疗阿片类药物的吸烟孕妇的医疗保健支出依赖性。这项两组随机对照临床试验（n = 100）将为测试提供关键的初步数据更大规模的试验。由于几乎所有 B-EPIC 服务都是通过公共和私人保险公司计费的服务；有高可持续性的可能性。