跳至主要内容
临床试验/NCT00218010
NCT00218010已完成不适用

Breastfeeding Among Methadone Maintained Women

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2000年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
methadone concentrations in maternal plasma

研究概览

简要总结

Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant. Currently, it is the treatment of choice for this group of people. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

详细描述

Methadone is a drug that is commonly used to treat opiate addiction, usually as part of a detoxification and maintenance program. Methadone offers significant therapeutic benefits to pregnant women who are opiate dependent, and it is currently the treatment of choice for this group of people. In general, breast milk is beneficial for infants. However, there is some concern as to whether it is safe for women who are taking methadone to breastfeed their babies. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Participants will be assigned to one of two groups: women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies. On Days 1, 2, 3, 4, 14, and 30, following infant delivery, plasma will be collected from both groups and breast milk will be collected from the breastfeeding group. These samples will be quantitatively analyzed for methadone. Infants will undergo neurobehavioral assessments on Days 3, 14, and 30, following birth. Rates and severity of neonatal abstinence syndrome will also be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Generally healthy methadone-maintained women electing to either exclusively breastfeed or bottle-feed their infants for 1 month after delivery

排除标准

  • Relapse to illicit drugs or alcohol at any time during the study
  • Positive maternal or infant urine toxicology test at birth
  • Serious medical or psychiatric illness requiring medication or medical intervention
  • HIV infected
  • Currently dependent on alcohol
  • Major birth defect in the infant
  • Significant medical problems in the infant, including premature birth, sepsis, or other infections

结局指标

主要结局

methadone concentrations in maternal plasma

时间窗: 1-30 days after delivery

methadone concentrations in breast milk

时间窗: 1-30 days after delivery

次要结局

  • methadone concentrations in infant plasma(1-30 days after delivery)

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Associate Professor of Pediatrics

National Institute on Drug Abuse (NIDA)

研究点 (1)

Loading locations...

相似试验