An observational study in Opioid-Related Disorders, Drug Addiction and Pregnancy Related, sponsored by T. John Winhusen, PhD. Completed at 10 sites in United States. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by T. John Winhusen, PhD · Observational
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.
Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.
Exclusion Criteria:
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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.).
Drug: Buprenorphine Injection
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.).
Drug: Buprenorphine Sublingual Product
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Also known as: CAM2038
Sublingual buprenorphine (BUP-SL), administered daily.
Also known as: Subutex, Suboxone
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
Supporting information: Study protocol
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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T. John Winhusen, PhD