Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
Key facts
- Who runs it
- T. John Winhusen, PhD
- Where
- Boston, Charleston, Huntington, Jacksonville, Nashville, Pittsburgh, Portland, Salt Lake City, and Seattle, United StatesSee the 10 sites
- Trial code
- Status
- Completed
- People taking part
- 71 people enrolled
- Started
- 14 Jun 2021
- Ended
- 30 Dec 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Buprenorphine Injection
- Buprenorphine Sublingual Product
- Record updated
- 16 March 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1)
Who cannot take part
- -
Where in United States
- Boston Medical CenterBoston, United States
- Massachusetts General Hospital HOPE ClinicBoston, United States
- Medical University of South CarolinaCharleston, United States
- Marshall Health MARC ProgramHuntington, United States
- Gateway Community ServicesJacksonville, United States
- Vanderbilt University Medical CenterNashville, United States
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMCPittsburgh, United States
- CODA, Inc.Portland, United States
- University of Utah SUPeRAD ClinicSalt Lake City, United States
- Addiction Recovery Services (ARS), Swedish Medical CenterSeattle, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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.).
Treatment: Buprenorphine Injection
- 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.).
Treatment: Buprenorphine Sublingual Product
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study
- Record updated
- 16 March 2026