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

项目摘要 与产前阿片类药物依赖和新生儿相关的医疗、心理和经济问题 禁欲综合症(NAS)在美国已经达到了流行的程度。解决方案包括优化 治疗阿片类药物依赖孕妇，同时减轻NAS和其他严重程度 产前阿片类药物暴露的神经行为后果。目前，只提供美沙酮维持服务 标准情况是，由于NAS较温和，更多的供应商只在美国开丁丙诺啡处方。美沙酮 尽管治疗对许多妇女有利，但由于其频率和严重程度，治疗是一个困难的选择。 NAS。丁丙诺啡-仅有很高的转移/滥用潜力，并不总是容易获得，并且可以 对某些女性有令人不快的副作用。丁丙诺啡-纳洛酮(B+N)治疗妊娠妇女 可能是一个有吸引力和有效的策略，因为拮抗剂成分，可以导致减少 滥用责任，减少转移的风险，并通过增加服药依从性提高药物有效性， 所有这些都可以帮助降低NAS的严重性。然而，目前还没有发布的报告表明 对产妇、胎儿和婴儿的功能进行前瞻性评估，并维持产妇的B+N水平。 同样，目前还没有数据支持哺乳--这是降低NAS严重程度的另一种策略 B+N中的快速型女性。 本机制研究的目的是评估母体B+N维持对健康的影响。 胎儿和婴儿的神经行为发育。为了做到这一点，我们将研究120个阿片类药物的样本 依赖的孕妇将接受B+N作为药物滥用治疗的一部分 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 并将在4点通过已建立的母胎数据采集系统评估产妇生理。 孕期评分：24周、28周、32周、36周。婴儿出生参数和NAS频谱显示将 在出生时进行评估，婴儿神经发育将在生命的第一个月进行评估。我们会比较一下 单用美沙酮和丁丙诺啡对B+N暴露胎儿和婴儿神经发育的影响 暴露的胎儿和婴儿。此外，母乳、母婴血浆中的B+N浓度 在母乳喂养的妇女中维持B+N将被确定。NAS参数与神经行为 B+N母乳喂养婴儿的情况将与B+N暴露配方奶粉喂养的婴儿进行比较。

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.