PHARMACOKINETICS OF METHADONE

这是一项进行美沙酮药代动力学和药效学研究的建议。口服剂量为0.2毫克/公斤，将由同等数量的健康男性和女性志愿者(男女各6名)在单一场合服用。在服药后96小时内的多个时间点采血，用于实验室测定美沙酮的分离异构体的血浆浓度及其与血浆蛋白结合的程度。这项研究的首要目标是根据从女性怀孕早期随机采集的血液样本获得的数据，预测个别怀孕成瘾者的美沙酮剂量，这将导致最小限度的新生儿戒断综合征，同时保持母亲对阿片类药物的依赖。目前提出的这项研究将收集实现这一目标的初步试点数据。

This is a proposal to conduct a pharmacokinetic and pharmacodynamic study of methadone. An oral dose, 0.2 mg/kg, will be taken by an equal number of healthy male and female volunteers (6 of each gender) on a single occasion. Blood will be sampled at multiple time points out of 96 hours after the dose for lab mesurement of the plasma concentration of methadone's seperate isomers and the extent of their plasma protein binding. The overarching goal of this research is to predict the dose of methadone for an individual pregnant addict based on data obtained from randomly collected blood samples early in the women's pregnancy that would result in a mimimal neonatal withdrawal syndrome while maintaining the mother's opiate dependence. This currently proposed study will collect the initial pilot data toward achieving this goal.