NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 10
- 主要终点
- Bayley Scales of Infant Development
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). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must be the caretaker of an infant that was delivered as part of 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
Bayley Scales of Infant Development
时间窗: 24 months post-partum
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
次要结局
- Bayley Scales of Infant Development(12 months post-partum)
- Child Behavior Checklist(24 months post-partum)
研究者
T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
University of Cincinnati