Morphine vs Methadone for Neonatal Opioid Withdrawal Syndrome
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if participants must stop taking their current medications. However, it focuses on infants already receiving morphine or methadone for neonatal opioid withdrawal syndrome, so these medications will continue as part of the study.
What data supports the effectiveness of morphine and methadone for treating Neonatal Opioid Withdrawal Syndrome (NOWS)?
Research shows that both morphine and methadone are used to treat NOWS, but there is no clear evidence that one is more effective than the other. A study found no significant differences in therapeutic response among infants treated with methadone, phenobarbital, and diazepam, suggesting methadone can be effective. However, another study indicated that morphine treatment did not significantly reduce withdrawal symptoms in methadone- and buprenorphine-exposed infants.12345
Is methadone or morphine safe for treating neonatal opioid withdrawal syndrome?
Methadone is commonly used to treat opioid dependence in pregnant women and is generally considered safe, but it can lead to neonatal abstinence syndrome (withdrawal symptoms in newborns). Morphine has been used to treat these withdrawal symptoms in newborns, and studies suggest it is safe for this purpose. Both medications have been studied in various settings and are generally safe when used under medical supervision.26789
How do methadone and morphine differ as drugs for treating neonatal opioid withdrawal syndrome?
Methadone and morphine are both used to treat neonatal opioid withdrawal syndrome, but methadone may offer a more stable treatment due to its longer half-life, which means it stays in the body longer and may require less frequent dosing compared to morphine. This can potentially lead to a shorter hospital stay and treatment duration for newborns.2341011
Research Team
Abbot R Laptook, MD
Principal Investigator
Women and Infants Hospital of Rhode Island
Abhik Das, PhD
Principal Investigator
RTI International
Adam Czynski, DO
Principal Investigator
Connecticut Children's Medical Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Stabilization
Infants are stabilized with an opioid to control NOWS signs before weaning begins
Weaning
Infants undergo either rapid or slow weaning of opioid treatment
Post-weaning Observation
Infants are observed in the hospital for at least 48 hours after cessation of opioid treatment
Follow-up
Participants are monitored for neurodevelopment and caregiver well-being at multiple intervals post-discharge
Treatment Details
Interventions
- Methadone
- Morphine
Methadone is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
- Pain management
- Opioid use disorder
- Pain management
- Opioid dependence
- Pain management
- Opioid use disorder
- Pain management
- Pain management
- Opioid dependence
Find a Clinic Near You
Who Is Running the Clinical Trial?
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator