Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Public ClinicalTrials.gov record NCT03911466. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. 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).
Study identification
- NCT ID
- NCT03911466
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 97 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 41 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 20, 2020
- Primary completion
- Nov 5, 2024
- Completion
- Nov 5, 2024
- Last update posted
- Mar 15, 2026
2020 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gateway Community Services | Jacksonville | Florida | 32204 | — |
| Massachusetts General Hospital HOPE Clinic | Boston | Massachusetts | 02114 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of New Mexico Milagro Clinic | Albuquerque | New Mexico | 87106 | — |
| University of Cincinnati Health Perinatal Addictions Program | Cincinnati | Ohio | 45229 | — |
| CODA, Inc. | Portland | Oregon | 97214 | — |
| Pregnancy Recovery Center at Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Utah SUPeRAD Clinic | Salt Lake City | Utah | 84108 | — |
| Addiction Recovery Services (ARS), Swedish Medical Center | Seattle | Washington | 98107 | — |
| Marshall Health MARC Program | Huntington | West Virginia | 25701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03911466, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03911466 live on ClinicalTrials.gov.