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

基本信息

批准号：
10062932
负责人：
LAUREN M JANSSON
金额：
$ 58.29万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/10062932
关键词：
Acute Adherence Adverse effects Age-Months Birth Brain Breast Feeding Breastfed infant Buprenorphine Caring Child Rearing Comprehensive Health Care Data Development Drug Prescriptions 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

项目摘要

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.

项目概要与产前阿片类药物依赖和新生儿相关的医疗、社会心理和财务问题戒断综合症 (NAS) 在美国已达到流行病的程度，解决方案包括优化系统。对阿片类药物依赖孕妇进行治疗，同时减轻 NAS 和其他疾病的严重程度目前，仅提供美沙酮维持治疗。标准情况下，由于美沙酮较温和，美国有更多的医疗服务提供者仅开出丁丙诺啡处方。治疗虽然对许多女性有利，但由于治疗的频率和严重程度而成为一个困难的选择仅丁丙诺啡具有很高的转移/滥用潜力，并不总是容易获得，并且可以丁丙诺啡-纳洛酮（B+N）治疗孕妇有令人不快的副作用。由于拮抗剂成分，这可能是一种有吸引力且有效的策略，这可以减少滥用倾向，降低转移风险并通过增加用药依从性提高药物有效性，所有这些都可以降低 NAS 的严重程度，但是目前还没有发表的报告。通过母体 B+N 维持对母体、胎儿和婴儿功能进行前瞻性评估。同样，目前没有数据支持哺乳——降低 NAS 严重程度的另一种策略表达——B+N 维持的女性。这项机制研究的目的是评估母亲 B+N 维持对胎儿的影响为了实现这一目标，我们将研究 120 种阿片类药物的样本。作为药物滥用治疗的一部分，将在综合机构接受 B+N 的受抚养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。将通过已建立的母胎数据采集系统在 4 点对母体生理机能进行评估妊娠期间的点：24、28、32和36周将显示婴儿出生参数和NAS频谱。我们将在出生时进行评估，并在出生后第一个月进行婴儿神经发育评估。暴露于 B+N 的胎儿和婴儿的神经发育与仅使用美沙酮和丁丙诺啡的神经发育的关系此外，母乳、母亲和婴儿血浆中 B+N 的浓度。将确定维持 B+N 的母乳喂养妇女的 NAS 参数和神经行为。 B+N 母乳喂养婴儿的概况将与 B+N 暴露配方奶喂养的婴儿进行比较。