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

Running, not enrolling · Phase 3

Conditions studied: Neonatal Opioid Withdrawal Syndrome

In brief

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).

Key facts

Study ID

NCT04214834

Run by

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

People needed

189

Starts

2020-09-28

Expected to finish

2026-06-30

Last updated by the study team

2026-06-30

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospital Level
• Hospital provides pharmacologic treatment to at least an average of 12 opioid exposed infants each year
• Hospital uses a scoring system to assess for signs of NOWS (original or modified Finnegan Neonatal Abstinence Scoring system, Eat-Sleep or Console)
• Hospital provides opioid replacement therapy with either morphine or methadone as part of pharmacologic treatment of NOWS
• Infant Level
• Gestational age ≥ 36 weeks
• Receiving scheduled pharmacological therapy with morphine or methadone as the primary drug treatment for NOWS secondary to maternal opioid use
• Tolerating enteral feeds and medications by mouth

You may not qualify if…

• Hospital Level
• Hospitals discharge > 10% of infants from the hospital on opioid replacement therapy on average per year
• Infant Level
• Major birth defect (e.g. gastroschisis)
• Any major surgery (minor surgery [e.g., circumcision, digit ligation, frenulectomy] is not an exclusion criterion)
• Hypoxic-ischemic encephalopathy
• Seizures from etiologies other than NOWS
• Treatment with opioids for reasons other than NOWS
• Respiratory support (nasal cannula or greater) for > 72 hours
• Planned discharge from the hospital on opioids
• Use of other opioids (e.g., buprenorphine) as primary drugs for treatment of NOWS
• Weaning of morphine or methadone as the primary treatment of NOWS has started

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of Arkansas Medical Sciences — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• University of Iowa — Iowa City, Iowa, United States
• Ochsner Medical Regional Hospital — Kenner, Louisiana, United States
• Tulane University Health Science Center — New Orleans, Louisiana, United States
• Ochsner Baptist Clinical Trials Unit — New Orleans, Louisiana, United States
• MedStar Franklin Square — Hyattsville, Maryland, United States
• University of Massachusetts Memorial Medical Center-West Campus — Worcester, Massachusetts, United States
• Central Michigan University — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• RTI International — Durham, North Carolina, United States
• Metrohealth — Cleveland, Ohio, United States
• Nationwide Childeren's Hospital — Columbus, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• Sanford Health — Sioux Falls, South Dakota, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• The University of Tennessee Health Science Center — Memphis, Tennessee, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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