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COMPLETED

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

NCT03911466 · 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). 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).

Interventions

  • DRUG Buprenorphine Injection
  • DRUG Buprenorphine Sublingual Product

Study Locations (12)

Massachusetts

  • Massachusetts General Hospital HOPE Clinic — Boston
  • Boston Medical Center — Boston

Florida

  • Gateway Community Services — Jacksonville

New Mexico

  • University of New Mexico Milagro Clinic — Albuquerque

Ohio

  • University of Cincinnati Health Perinatal Addictions Program — Cincinnati

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

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2020-07-21
Est. Completion 2024-11-06

Sponsor

T. John Winhusen, PhD

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03911466

The ClinicalTrials.gov registry entry for NCT03911466 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 97 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: NCT03911466 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Massachusetts, Florida, New Mexico. 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 NCT03911466 about?

NCT03911466 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments 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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanism...

What is the current status of trial NCT03911466?

This trial is currently completed. The enrollment target is 97 participants. The study started on 2020-07-21. Estimated completion is 2024-11-06.

What conditions does trial NCT03911466 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 NCT03911466?

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 NCT03911466?

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 NCT03911466 being conducted?

This trial has 12 study locations across Florida, Massachusetts, New Mexico, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial