Fetal and Infant Neurobehavior in Opiate Dependent Women

阿片类药物依赖妇女的胎儿和婴儿神经行为

• 批准号: 7107294
• 负责人: LAUREN M JANSSON
• 金额: $ 38.14万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7107294
• 关键词: behavioral /social science research tag; buprenorphine; clinical research; clinical trials; data collection methodology /evaluation; dosage; drug abuse; drug abuse chemotherapy; drug screening /evaluation; embryo /fetus drug adverse effect; human pregnant subject; human therapy evaluation; methadone; neuropsychology; newborn human (0-6 weeks); outcomes research; patient oriented research; psychological tests

DESCRIPTION (provided by applicant): Methadone is widely used for the treatment of opioid dependent pregnant women, yet little is known about its effects on the developing fetus. Previous research by this group of investigators found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Maternal methadone administration was associated with significant depression in fetal neurobehaviors. This proposal seeks to: 1) Determine the effect of methadone treatment during pregnancy on maternal and fetal neurobehavioral functioning at trough and peak maternal methadone levels using single dose methadone therapy. This includes controlling for covariates such as individual maternal and fetal factors, which mediate or moderate these effects, and of factors that may potentiate the expression of neonatal abstinence syndrome. 2) Determine whether split dose methadone therapy for pregnant women lessens or ameliorates the previously observed deleterious effects of single dose treatment on maternal physiologic and fetal neurobehavioral functioning. 3) Determine the effects of buprenorphine treatment on maternal physiologic and fetal neurobehavioral functioning and compare them to those found in opioid dependent pregnant women treated with methadone. This aspect of the proposal will be in collaboration with the NIDA funded multi-site, double blind, randomized controlled study evaluating the effect of buprenoprphine versus methadone on neonatal outcome. The project will utilize a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate, the interaction between the two (coupling) and maternal physiologic parameters; build upon pilot data obtained from a Mentored Clinical Scientist award received by the PI, and bring together the expertise of three established research teams. Information gained from this proposal has the potential to significantly impact the way in which we treat the difficult and high-risk population of opiate dependent pregnant women.

描述（由申请人提供）： 美沙酮广泛用于治疗阿片类药物依赖孕妇，但对其对发育中胎儿的影响知之甚少。这组研究人员之前的研究发现，怀孕期间的美沙酮治疗直接影响胎儿的神经生理学，独立于母体生理学。母亲服用美沙酮与胎儿神经行为的显着抑制有关。该提案旨在： 1) 使用单剂量美沙酮治疗确定妊娠期间美沙酮治疗对母体美沙酮谷值和峰值水平下母体和胎儿神经行为功能的影响。这包括控制协变量，例如介导或减轻这些影响的个体母体和胎儿因素，以及可能增强新生儿戒断综合征表达的因素。 2) 确定孕妇分次剂量美沙酮治疗是否会减轻或改善先前观察到的单剂量治疗对母体生理和胎儿神经行为功能的有害影响。 3) 确定丁丙诺啡治疗对母体生理和胎儿神经行为功能的影响，并将其与接受美沙酮治疗的阿片类药物依赖孕妇的影响进行比较。该提案的这方面将与 NIDA 资助的多中心、双盲、随机对照研究合作，评估丁丙诺啡与美沙酮对新生儿结局的影响。该项目将利用最先进的计算机化胎儿心电图和数据分析程序来同时评估胎儿运动和心率、两者之间的相互作用（耦合）以及母体生理参数；以 PI 获得的指导临床科学家奖获得的试点数据为基础，并汇集了三个已建立的研究团队的专业知识。从该提案中获得的信息有可能对我们治疗阿片类药物依赖孕妇的困难和高风险人群的方式产生重大影响。