ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04214834

Public ClinicalTrials.gov record NCT04214834. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 11:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Study identification

NCT ID
NCT04214834
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Enrollment
189 participants

Conditions and interventions

Interventions

  • Methadone Drug
  • Morphine Drug

Drug

Eligibility (public fields only)

Age range
36 Weeks and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 27, 2020
Primary completion
Jan 30, 2024
Completion
Jun 29, 2026
Last update posted
Mar 12, 2025

2020 – 2026

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
21
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35249
University of Arizona Tucson Arizona 85724
University of Arkansas Medical Sciences Little Rock Arkansas 72202
Loma Linda University Medical Center Loma Linda California 92354
Sharp Mary Birch Hospital for Women and Newborns San Diego California 92123
University of Iowa Iowa City Iowa 52242
Ochsner Medical Regional Hospital Kenner Louisiana 70065
Tulane University Health Science Center New Orleans Louisiana 70001
Ochsner Baptist Clinical Trials Unit New Orleans Louisiana 70115
MedStar Franklin Square Hyattsville Maryland 20782
University of Massachusetts Memorial Medical Center-West Campus Worcester Massachusetts 01605
Central Michigan University Detroit Michigan 48201
Children's Mercy Hospital Kansas City Missouri 64108
Washington University School of Medicine St Louis Missouri 63110
University of New Mexico Albuquerque New Mexico 87131
RTI International Durham North Carolina 27705
Metrohealth Cleveland Ohio 44109
Nationwide Childeren's Hospital Columbus Ohio 43205
Ohio State University Hospital Columbus Ohio 43210
Women & Infants Hospital of Rhode Island Providence Rhode Island 02905
Sanford Health Sioux Falls South Dakota 57104
University of Tennessee Health Science Center Memphis Tennessee 38119
The University of Tennessee Health Science Center Memphis Tennessee 38163
West Virginia University Hospital Morgantown West Virginia 26506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04214834, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 12, 2025 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04214834 live on ClinicalTrials.gov.

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