Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Key facts
- Who runs it
- T. John Winhusen, PhD
- Where
- Albuquerque, Boston, Charleston, Cincinnati, Huntington, Jacksonville, Nashville, Pittsburgh, Portland, Salt Lake City, and Seattle, United StatesSee the 12 sites
- Trial code
- Status
- Completed
- People taking part
- 97 people enrolled
- Started
- 21 Jul 2020
- Ended
- 6 Nov 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Buprenorphine Injection
- Buprenorphine Sublingual Product
- Record updated
- 16 March 2026
Who can take part
- Age
- 18 years to 41 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
Who cannot take part
- -
Where in United States
- University of New Mexico Milagro ClinicAlbuquerque, United States
- Boston Medical CenterBoston, United States
- Massachusetts General Hospital HOPE ClinicBoston, United States
- Medical University of South CarolinaCharleston, United States
- University of Cincinnati Health Perinatal Addictions ProgramCincinnati, 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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
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It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
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): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
- Record updated
- 16 March 2026