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Opioid Agonist

Morphine vs Methadone for Neonatal Opioid Withdrawal Syndrome

Phase 3
Waitlist Available
Led By Abhik Das, PhD
Research Sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant Level: Tolerating enteral feeds and medications by mouth
Infant Level: Gestational age ≥ 36 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of birth until hospital discharge or 1 year whichever comes first
Awards & highlights

Study Summary

This trial will compare the effect of two different weaning methods on the number of days of opioid treatment for infants with NOWS.

Who is the study for?
This trial is for newborns with Neonatal Opioid Withdrawal Syndrome (NOWS) who are at least 36 weeks gestational age, can take oral feeds and medications, and are receiving morphine or methadone. Hospitals must treat an average of 12 opioid-exposed infants yearly. Infants with seizures not due to NOWS, needing significant respiratory support, already weaning off opioids, having major surgery or defects, or planned discharge on opioids cannot participate.Check my eligibility
What is being tested?
The study aims to compare two methods of reducing opioid treatment in infants with NOWS: a rapid wean versus a slow-wean approach. It measures the time from starting to reduce the dose until stopping it completely using either morphine or methadone as primary treatments.See study design
What are the potential side effects?
Possible side effects include symptoms related to withdrawal management such as irritability, sleep disturbances, feeding difficulties and potential respiratory issues. The specific side effects will depend on whether morphine or methadone is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My infant can take food and medicine by mouth.
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My baby was born at or after 36 weeks of pregnancy.
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My baby is on a treatment plan with morphine or methadone for withdrawal symptoms due to my opioid use.
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My hospital offers morphine or methadone for withdrawal treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of birth until hospital discharge or 1 year whichever comes first
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of birth until hospital discharge or 1 year whichever comes first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of days of opioid treatment
Secondary outcome measures
Infant development
Infant growth
Infant wellness
+10 more

Trial Design

2Treatment groups
Active Control
Group I: Rapid-weanActive Control2 Interventions
15% decrements from the stabilization dose of morphine/methadone
Group II: Slow-weanActive Control2 Interventions
10% decrements from the stabilization dose of morphine/methadone

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,551 Total Patients Enrolled
1 Trials studying Neonatal Opioid Withdrawal Syndrome
300 Patients Enrolled for Neonatal Opioid Withdrawal Syndrome
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) ProgramLead Sponsor
2 Previous Clinical Trials
1,605 Total Patients Enrolled
1 Trials studying Neonatal Opioid Withdrawal Syndrome
300 Patients Enrolled for Neonatal Opioid Withdrawal Syndrome
Abhik Das, PhDPrincipal InvestigatorRTI International
30 Previous Clinical Trials
181,479 Total Patients Enrolled

Media Library

Methadone (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04214834 — Phase 3
Neonatal Opioid Withdrawal Syndrome Research Study Groups: Rapid-wean, Slow-wean

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the conditions that Rapid-wean is mostly used to treat?

"Rapid-wean is an effective therapeutic procedure for patients struggling with pain and opioid addiction."

Answered by AI

How often are there side effects associated with Rapid-wean?

"There is some evidence, from both Phase 3 clinical trials and other data sources, to support the Rapid-wean intervention's safety."

Answered by AI

Are there any geographical restrictions to participating in this research?

"There are 28 enrolling patients for this trial at locations including University of Arizona in Tucson, Ochsner Baptist Clinical Trials Unit in New Orleans, and University of Massachusetts Memorial Medical Center-West Campus in Worcester."

Answered by AI

Are people with the required medical condition still able to enroll in this research trial?

"That is correct, the online information from clinicaltrials.gov affirms that this clinical trial is still looking for willing participants. September 8th, 2020 is when the study was first announced, with the latest update happening on June 22nd, 2022. So far, 502 individuals are needed for the 28 different sites."

Answered by AI

What other medical studies have included Rapid-wean in their research?

"As of now, there are 69 ongoing clinical trials for Rapid-wean, 18 of which are in the third and final phase. Most of the research is conducted in Amersfoort, Noord Holland, but there are a total of 165 locations running trials for Rapid-wean."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Loma Linda University Medical Center
University of New Mexico
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
2020. "Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04214834.
~41 spots leftby Apr 2025
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