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COMPLETED Phase 3

Medication Treatment for Opioid Use Disorder in Expectant Mothers

NCT03918850 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

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 140 participants
Start Date 2020-07-21
Est. Completion 2025-01-31
Phase Phase 3

Sponsor

T. John Winhusen, PhD

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03918850

The ClinicalTrials.gov registry entry for NCT03918850 describes a study currently listed as completed. It is categorized as Phase 3, 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 140 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: NCT03918850 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 NCT03918850 about?

NCT03918850 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers". The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not h...

What is the current status of trial NCT03918850?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2020-07-21. Estimated completion is 2025-01-31.

What conditions does trial NCT03918850 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 NCT03918850?

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 NCT03918850?

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 NCT03918850 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