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COMPLETED

MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

NCT03718104 · View on ClinicalTrials.gov ↗

Study Summary

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.

Interventions

  • OTHER Pharmacokinetic analysis
  • OTHER Safety and Efficacy
  • GENETIC Genetic and epigenetic analysis
  • OTHER Breast milk analysis

Study Locations (2)

Massachusetts

  • Boston Medical Center — Boston

North Carolina

  • University of North Carolina Chapel Hill — Carrboro

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2018-12-01
Est. Completion 2024-05-08

Sponsor

Boston Medical Center

192 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03718104

The ClinicalTrials.gov registry entry for NCT03718104 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 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 192 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 4 interventions — of which Pharmacokinetic analysis 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: NCT03718104 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, North Carolina. 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 NCT03718104 about?

NCT03718104 is a clinical study titled "MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study". This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared...

What is the current status of trial NCT03718104?

This trial is currently completed. The enrollment target is 46 participants. The study started on 2018-12-01. Estimated completion is 2024-05-08.

What conditions does trial NCT03718104 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Opioid-use Disorder, Pregnancy, High Risk, 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 NCT03718104?

The interventions under investigation include: Pharmacokinetic analysis (OTHER), Safety and Efficacy (OTHER), Genetic and epigenetic analysis (GENETIC), Breast milk analysis (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03718104?

This trial is sponsored by Boston Medical Center, which has 192 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03718104 being conducted?

This trial has 2 study locations across Massachusetts, North Carolina. 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