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NCT04214834 · ClinicalTrials.gov registry record · Phase 3

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

A Phase 3 study of Neonatal Opioid Withdrawal Syndrome, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.

Active
Registry status
Phase 3
Development phase
189
Enrollment target
20
Study locations

NCT04214834 is a Phase 3 study of Neonatal Opioid Withdrawal Syndrome that is active but no longer recruiting, run by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program. The registered enrollment target is 189 participants, roughly in line with the 207-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target. The trial reports 20 study locations across 14 states.

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The verdict

NCT04214834, a Phase 3 study of Neonatal Opioid Withdrawal Syndrome, is active but no longer recruiting, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
189 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome (NOWS).

Conditions Studied

Neonatal Opioid Withdrawal Syndrome

Interventions

  • DRUG Methadone
  • DRUG Morphine

Study Locations (20)

Louisiana

  • Ochsner Medical Regional Hospital - Kenner
  • Tulane University Health Science Center - New Orleans
  • Ochsner Baptist Clinical Trials Unit - New Orleans

Ohio

  • Metrohealth - Cleveland
  • Nationwide Childeren's Hospital - Columbus
  • Ohio State University Hospital - Columbus

California

  • Loma Linda University Medical Center - Loma Linda
  • Sharp Mary Birch Hospital for Women and Newborns - San Diego

Missouri

  • Children's Mercy Hospital - Kansas City
  • Washington University School of Medicine - St Louis

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • University of Arizona - Tucson

Arkansas

  • University of Arkansas Medical Sciences - Little Rock

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 189 participants
Start Date 2020-09-28
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04214834

The ClinicalTrials.gov registry entry for NCT04214834 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 207-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target. The listed sponsor is Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Methadone is the first listed.

NCT04214834 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Louisiana, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT04214834 about?

NCT04214834 is a clinical study titled "Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)". The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as...

What is the current status of trial NCT04214834?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 189 participants. The study started on 2020-09-28. Estimated completion is 2026-06-30.

What conditions does trial NCT04214834 study?

This clinical trial studies the following conditions: Neonatal Opioid Withdrawal Syndrome.

What interventions are being tested in trial NCT04214834?

The interventions under investigation include: Methadone (DRUG), Morphine (DRUG).

Who is sponsoring clinical trial NCT04214834?

This trial is sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04214834 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.