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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Sublingual buprenorphine (BUP-SL), administered daily.
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
Bayley Scales of Infant Development
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.
Time frame: 24 months post-partum
Bayley Scales of Infant Development
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.
Time frame: 12 months post-partum
Child Behavior Checklist
The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
Time frame: 24 months post-partum
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