PHARMACOKINETICS OF METHADONE

本文拟对美沙酮进行药代动力学和药效学研究。将由同等数量的健康男性和女性志愿者（男女各6人）一次口服剂量为0.2 mg/kg。在给药后96小时内的多个时间点取血，用于实验室测量美沙酮不同异构体的血浆浓度及其血浆蛋白结合程度。本研究的首要目标是根据从妇女妊娠早期随机采集的血液样本中获得的数据，预测怀孕成瘾者个体的美沙酮剂量，这将导致最小的新生儿戒断综合征，同时保持母亲的阿片类药物依赖。目前提出的这项研究将收集初步试点数据，以实现这一目标。

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.