Breastfeeding Among Methadone Maintained Women
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
- 否
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
Associate Professor of Pediatrics
National Institute on Drug Abuse (NIDA)
