Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
- Conditions
- Drug AbusePregnancy RelatedNeonatal Opiate Withdrawal SyndromeDrug AddictionNeonatal Abstinence SyndromeOpioid-Related DisordersSubstance AbuseDrug Abuse in Pregnancy
- Interventions
- Registration Number
- NCT03911739
- Lead Sponsor
- T. John Winhusen, PhD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BUP-XR Buprenorphine Injection 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.). BUP-SL Buprenorphine Sublingual Product 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.).
- Primary Outcome Measures
Name Time Method Bayley Scales of Infant Development 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.
- Secondary Outcome Measures
Name Time Method Bayley Scales of Infant Development 12 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.
Child Behavior Checklist 24 months post-partum The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Trial Locations
- Locations (10)
Gateway Community Services
🇺🇸Jacksonville, Florida, United States
Massachusetts General Hospital HOPE Clinic
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CODA, Inc.
🇺🇸Portland, Oregon, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah SUPeRAD Clinic
🇺🇸Salt Lake City, Utah, United States
Addiction Recovery Services (ARS), Swedish Medical Center
🇺🇸Seattle, Washington, United States
Marshall Health MARC Program
🇺🇸Huntington, West Virginia, United States