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Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
NCT03911739 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Buprenorphine Injection
- DRUG Buprenorphine Sublingual Product
Study Locations (10)
Massachusetts
- Massachusetts General Hospital HOPE Clinic — Boston
- Boston Medical Center — Boston
Florida
- Gateway Community Services — Jacksonville
Oregon
- CODA, Inc. — Portland
Pennsylvania
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMC — Pittsburgh
South Carolina
- Medical University of South Carolina — Charleston
Tennessee
- Vanderbilt University Medical Center — Nashville
Utah
- University of Utah SUPeRAD Clinic — Salt Lake City
Washington
- Addiction Recovery Services (ARS), Swedish Medical Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2024-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03911739
The ClinicalTrials.gov registry entry for NCT03911739 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is T. John Winhusen, PhD, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions — of which Buprenorphine Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03911739 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, Florida, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03911739 about?
NCT03911739 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study". 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 evaluat...
What is the current status of trial NCT03911739?
This trial is currently completed. The enrollment target is 71 participants. The study started on 2021-06-14. Estimated completion is 2024-12-30.
What conditions does trial NCT03911739 study?
This clinical trial studies the following conditions: Pregnancy Related, Substance Abuse, Opioid-Related Disorders, Drug Abuse, Neonatal Abstinence Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03911739?
The interventions under investigation include: Buprenorphine Injection (DRUG), Buprenorphine Sublingual Product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03911739?
This trial is sponsored by T. John Winhusen, PhD, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03911739 being conducted?
This trial has 10 study locations across Florida, Massachusetts, Oregon, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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