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NCT00218621 · ClinicalTrials.gov registry record

The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1

A clinical trial, sponsored by Johns Hopkins University.

Completed
Registry status
20
Enrollment target

NCT00218621: Completed study, sponsored by Johns Hopkins University.

NCT00218621 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00218621 has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
20 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.

Interventions

  • PROCEDURE Buprenorphine / methadone

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2005-09
Est. Completion 2009-02
Johns Hopkins University

1,448 total trials

What the finished NCT00218621 record still lists

NCT00218621 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Buprenorphine / methadone is the first listed.

NCT00218621 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00218621 about?

NCT00218621 is a clinical study titled "The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1". The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment ...

What is the current status of trial NCT00218621?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2005-09. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00218621?

The interventions under investigation include: Buprenorphine / methadone (PROCEDURE).

Who is sponsoring clinical trial NCT00218621?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00218621, the US trial registry maintained by the National Library of Medicine. NCT00218621 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.