NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Concentration of buprenorphine and metabolites in maternal plasma
研究概览
简要总结
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant 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 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
排除标准
- 未提供
研究组 & 干预措施
BUP-XR
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
干预措施: Buprenorphine Injection (Drug)
BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
干预措施: Buprenorphine Sublingual Product (Drug)
结局指标
主要结局
Concentration of buprenorphine and metabolites in maternal plasma
时间窗: Delivery
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Cmin of buprenorphine and metabolites in plasma
时间窗: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Fetal heart rate variability
时间窗: Estimated gestational age (EGA) approximately 36 weeks
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Cmax of buprenorphine and metabolites in plasma
时间窗: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Concentration of buprenorphine and metabolites in cord plasma
时间窗: Delivery
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Cmin of buprenorphine and metabolites in plasma
时间窗: 2 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Cmin of buprenorphine and metabolites in plasma
时间窗: 4 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
次要结局
未报告次要终点
研究者
T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
University of Cincinnati