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Opioid Agonist

Morphine vs Methadone for Neonatal Opioid Withdrawal Syndrome

Phase 3

Waitlist Available

Led By Abbot Laptook, MD

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

Must not have

Infant Level: Planned discharge from the hospital on opioids

Infant Level: Hypoxic-ischemic encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of birth until hospital discharge or 1 year whichever comes first

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant is being discharged on opioid medication.

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My infant has brain damage due to lack of oxygen.

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My infant is being treated with opioids other than methadone for withdrawal.

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My infant has not had any major surgeries.

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My baby has begun treatment to stop dependency on morphine or methadone.

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My infant is being treated with opioids not for withdrawal symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of birth until hospital discharge or 1 year whichever comes first

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.