Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Neonatal Opioid Withdrawal Syndrome, sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The number of days of opioid treatment (used as primary treatment), including escalation, resumption, and spot treatment, from the first weaning dose to cessation of opioid. From the start of opioid study medication until weaning. Infants will exit the study intervention without unblinding (remain in the trial) if they have not weaned off study drug by 35 days (inclusive of the 35th day) form the first weaning dose. Outcome will be truncated at 35 days regardless of the study arm.We note that pr
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04214834 still lists
NCT04214834 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 207-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target.
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Neonatal Opioid Withdrawal Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Medication Treatment for Opioid Use Disorder in Expectant Mothers
COMPLETED · Phase 3
-
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
RECRUITING
-
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
RECRUITING
-
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
ACTIVE NOT RECRUITING
-
Neurostimulation to Improve NOWS Outcomes
ACTIVE NOT RECRUITING · NA
-
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02734537 · 189 participants · Phase 2
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
- NCT05058651 · 189 participants · Phase 2
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
- NCT05673408 · 189 participants
NIBP Validation Study
- NCT05994209 · 189 participants · Phase 1
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI