NCT00067184已完成不适用
Methadone, Buprenorphine and Fetal Development
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- fetal heart rate
研究概览
简要总结
The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.
详细描述
This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.
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
- •Maternal age 18-40 years
- •Single intrauterine fetus
- •Estimated gestational age of 32 weeks
- •DSMIV criteria for opioid dependence according to e-module of the SCID
- •Daily methadone maintenance at a stable dose for greater than a week
排除标准
- •Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
- •Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
- •Evidence of preterm labor
- •Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
- •Presence of major congenital fetal malformation
- •Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
- •Split methadone dosing schedule
结局指标
主要结局
fetal heart rate
时间窗: 120 minutes
fetal movement
时间窗: 120 minutes
次要结局
- neonatal abstinence syndrome(4 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Fetal Neurobehavior in Poly-drug Dependent WomenPoly Drug Exposed PregnanciesNCT00653692Johns Hopkins University29
已完成
2 期
Fetal and Infant Effects of Maternal Buprenorphine TreatmentNeonatal Abstinence SyndromeNCT01561079Johns Hopkins University127
已完成
不适用
Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse TreatmentPregnancyDrug AbuseNCT00522626Johns Hopkins University19
已完成
不适用
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1Opiate DependencePregnancyNCT00218621Johns Hopkins University20
已完成
不适用
Neonatal and Maternal Effects of Buprenorphine and MethadoneOpioid-maintained Pregnant WomenNCT03024736St. Louis University40