Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Maternal drug use relapse
研究概览
简要总结
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.
详细描述
Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
- •Plan to deliver infant at BMC or UNC
- •Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
- •English speaking
- •Singleton pregnancy
排除标准
- •OUD on prescribed methadone, or no maintenance medication
- •OUD on Subutex formulation of buprenorphine
- •Severe psychiatric illness or cognitively impairing ability to provide informed consent
- •Current maternal incarceration
- •Women who present for care >31 0/7 weeks
- •Multiple gestation pregnancy
结局指标
主要结局
Maternal drug use relapse
时间窗: up to 12 months post-delivery
Maternal relapse of illicit and/or unprescribed drug use from maternal/provider report and or from urine toxicology testing at any point during the pregnancy and up to 12 months after delivery
次要结局
- Fetal heart rate monitoring from NST(27- 41 weeks gestation)
- Infant hair cortisol levels(Birth and 4 weeks post-delivery)
- Naltrexone side effects or adverse events(up to 12 months post-delivery)
- Congenital fetal anomalies by ultrasound(18 - 41 weeks gestation)
- Infant weight(Birth, 4 weeks, and 12 months)
- Congenital anomalies by physical examination(Birth)
- Diagnosis of Neonatal Abstinence Syndrome (NAS)(From birth to 30 days)
- Infant need for adjunctive agent(From birth to 30 days)
- Infant opioid replacement pharmacologic treatment(From birth to 30 days)
- Biophysical profile score calculated from NST(27 - 41 weeks gestation)
- Fetal growth based on ultrasound measurements(18 - 41 weeks gestation)
- Infant need for pharmacologic treatment(From birth to 30 days)
- Infant length(Birth, 4 weeks, and 12 months)
- Infant head circumference(Birth, 4 weeks, and 12 months)
- Pharmacokinetic analysis of infant naltrexone levels(Delivery, 2-4 days after delivery, 4 weeks post-delivery)
- Maternal hair cortisol levels(Birth and 4 weeks post-delivery)
- Infant birth hospitalization length of stay(From birth to 30 days)
- Infant neurobehavior-function assessed by the NNNS(4 weeks of age)
- Pharmacokinetic analysis of maternal naltrexone levels(2nd trimester, 3rd trimester, delivery, 2-4 days after delivery, 4 weeks post-delivery)
- Infant neurodevelopment assessed by Bayley III(12 months of age)