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Could a quicker wean reduce opioid exposure in newborns?

NCT ID NCT04214834

Disease control Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study compares a rapid weaning schedule to a slower one for newborns being treated with morphine or methadone for neonatal opioid withdrawal syndrome (NOWS). The goal is to see if a faster wean can reduce the number of days babies need opioid medication. The trial includes full-term infants from hospitals that routinely treat opioid-exposed newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
morphine or methadone
What this could lead to
If successful, this could lead to shorter hospital stays and less opioid exposure for newborns with opioid withdrawal.
What could go wrong
The trial is relatively small and results may not apply to all hospitals or infants. Faster weaning might not be safe for all babies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

189 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

36 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Hospital Level 1. Hospital provides pharmacologic treatment to at least an average of 12 opioid exposed infants each year 2. Hospital uses a scoring system to assess for signs of NOWS (original or modified Finnegan Neonatal Abstinence Scoring system, Eat-Sleep or Console) 3. Hospital provides opioid replacement therapy with either morphine or methadone as part of pharmacologic treatment of NOWS * Infant Level 1. Gestational age ≥ 36 weeks 2. Receiving scheduled pharmacological therapy with morphine or methadone as the primary drug treatment for NOWS secondary to maternal opioid use 3. Tolerating enteral feeds and medications by mouth Exclusion Criteria: * Hospital Level 1\. Hospitals discharge \> 10% of infants from the hospital on opioid replacement therapy on average per year * Infant Level 1. Major birth defect (e.g. gastroschisis) 2. Any major surgery (minor surgery \[e.g., circumcision, digit ligation, frenulectomy\] is not an exclusion criterion) 3. Hypoxic-ischemic encephalopathy 4. Seizures from etiologies other than NOWS 5. Treatment with opioids for reasons other than NOWS 6. Respiratory support (nasal cannula or greater) for \> 72 hours 7. Planned discharge from the hospital on opioids 8. Use of other opioids (e.g., buprenorphine) as primary drugs for treatment of NOWS 9. Weaning of morphine or methadone as the primary treatment of NOWS has started

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal opioid withdrawal syndrome

Contacts and locations

Locations

  • Central Michigan University

    Detroit, Michigan, 48201, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

  • MedStar Franklin Square

    Hyattsville, Maryland, 20782, United States

  • Metrohealth

    Cleveland, Ohio, 44109, United States

  • Nationwide Childeren's Hospital

    Columbus, Ohio, 43205, United States

  • Ochsner Baptist Clinical Trials Unit

    New Orleans, Louisiana, 70115, United States

  • Ochsner Medical Regional Hospital

    Kenner, Louisiana, 70065, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Sanford Health

    Sioux Falls, South Dakota, 57104, United States

  • Sharp Mary Birch Hospital for Women and Newborns

    San Diego, California, 92123, United States

  • The University of Tennessee Health Science Center

    Memphis, Tennessee, 38163, United States

  • Tulane University Health Science Center

    New Orleans, Louisiana, 70001, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72202, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Massachusetts Memorial Medical Center-West Campus

    Worcester, Massachusetts, 01605, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38119, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.