Maternal buprenorphine-naloxone treatment during the perinatal period: Fetal and infant effects

围产期母亲丁丙诺啡-纳洛酮治疗：对胎儿和婴儿的影响

• 批准号: 9557471
• 负责人: LAUREN M JANSSON
• 金额: $ 58.57万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9557471
• 关键词: Acute; Adherence; Adverse effects; Age-Months; Birth; Brain; Breast Feeding; Breastfed infant; Buprenorphine; Caring; Child Rearing; Comprehensive Health Care; Data; Development; Effectiveness; Epidemic; Evaluation; Fetal Development; Fetus; Frequencies; Goals; Hospitalization; Human Milk; Incidence; Infant; Infant Care; Knowledge; Lactation; Life; Maintenance; Maternal Physiology; Medicaid; Medical; Methadone; Mothers; Naloxone; Neonatal Abstinence Syndrome; Newborn Infant; Opiate Addiction; Opioid; Pharmaceutical Preparations; Physiological; Plasma; Pregnancy; Pregnant Women; Provider; Publishing; Relapse; Reporting; Research; Risk; Sampling; Severities; Societies; Suboxone; Substance Use Disorder; System; Time; Woman; Work; antenatal; base; care costs; cohort; data acquisition; design; fetal; fetal opioid exposure; medication compliance; medication-assisted treatment; methadone treatment; neonate; neurobehavior; neurobehavioral; neurodevelopment; offspring; opioid use; opioid use disorder; perinatal period; pregnant; prenatal; prevent; prospective; psychosocial; side effect; substance abuse treatment; treatment choice; treatment optimization

Project Summary Medical, psychosocial and financial problems associated with prenatal opioid dependency and Neonatal Abstinence Syndrome (NAS) have reached epidemic proportions in the US. Solutions include optimizing the treatment for opioid dependent pregnant women while mitigating the severity of NAS and other neurobehavioral consequences of prenatal opioid exposure. Currently, only methadone maintenance is offered standardly, with more providers prescribing buprenorphine-only in the US due to milder NAS. Methadone treatment, although advantageous for many women, is a difficult choice due to the frequency and severity of the NAS. Buprenorphine-only has a high diversion/abuse potential, is not always readily availble, and can have unpleasant side effects in some women. Buprenorphine-naloxone (B+N) treatment of pregnant women may be an attractive and effective strategy due to the antagonist component, which can result in reduced abuse liability, reduced risk of diversion and increased drug effectiveness by increasing medicaiton adherence, all of which can serve to decrease NAS severity. However, there are currently no published reports that provide a prospective assessment of maternal, fetal and infant functioning with maternal B+N maintenance. Similarly, there is no data available today to support lactation – another strategy to reduce the severity of NAS expresssion - in B+N maintained women. The purpose of this mechanistic study is to evaluate the effects that maternal B+N maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, we will study a sample of 120 opioid dependent pregnant women that will receive B+N as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and NAS spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life. We will compare the neurodevelopment of the B+N-exposed fetuses and infants to that of methadone and buprenorphine-only exposed fetuses and infants. In addition, concentrations of B+N in breast milk, maternal and infant plasma among breastfeeding women maintained on B+N will be determined. NAS parameters and neurobehavioral profiles of B+N breastfed infants will be compared to B+N exposed formula fed infants.

项目摘要 与产前阿片类药物依赖和新生儿相关的医疗、社会心理和经济问题 禁欲综合症（NAS）在美国已经达到流行病的程度。解决方案包括优化 治疗阿片类药物依赖的孕妇，同时减轻NAS和其他 产前阿片类药物暴露的神经行为后果目前只提供美沙酮维持治疗 在美国，由于更温和的NAS，更多的供应商仅处方丁丙诺啡。美沙酮 治疗，虽然对许多妇女有利，是一个困难的选择，由于频率和严重性， NAS。仅丁丙诺啡具有很高的转移/滥用潜力，并不总是容易获得， 对某些女性有不良的副作用丁丙诺啡-纳洛酮（B+N）治疗孕妇 由于拮抗剂组分，可能是一种有吸引力的有效策略， 滥用倾向，减少转移的风险，并通过增加药物依从性来提高药物有效性， 所有这些都可以用于降低NAS严重性。然而，目前没有任何公开报道称， 提供母体B+N维持的母体、胎儿和婴儿功能的前瞻性评估。 同样，目前也没有数据支持哺乳--这是另一种降低NAS严重程度的策略 B+N维持组女性表达率为100%。 本机制研究的目的是评价母体B+N维持对水稻生长发育的影响。 胎儿和婴儿的神经行为发育。为了实现这一目标，我们将研究120种阿片类药物的样本 将接受B+N作为药物滥用治疗的一部分的依赖性孕妇， 为患有药物使用障碍的孕妇和育儿妇女提供护理治疗设施。胎儿神经行为 和母体生理学将通过建立的母胎数据采集系统在4 妊娠期间的时间点：24、28、32和36周。婴儿出生参数和NAS频谱显示将 在出生时进行评估，婴儿的神经发育将在出生后的第一个月进行评估。我们将比较 B+ N暴露的胎儿和婴儿的神经发育与仅美沙酮和丁丙诺啡的神经发育相比 暴露的胎儿和婴儿。此外，母乳、母亲和婴儿血浆中的B+N浓度 将确定维持B+N的母乳喂养妇女中的比例。NAS参数和神经行为 将比较B+N母乳喂养婴儿与接触B+N配方奶粉喂养婴儿的情况。