CompletedPhase 4

Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal

31 participantsStarted 2011-01

Plain-language summary

Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.

Who can participate

Age range

2 Hours – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores \> 8 in an 8 hour time period, AND ii. Gestation =\> 35 weeks at entry defined by best obstetrical and physical exam criteria, AND iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine. Exclusion Criteria: i. Gestation \< 35 weeks at entry defined by best obstetrical and physical exam criteria. ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected, iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU. iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course v. Mother consistently taking prescribed benzodiazepine at the time of delivery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Days of Treatment With Opioid Medication

Timeframe: From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months

Trial details

NCT IDNCT01804075

SponsorEastern Maine Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2017-07-27

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials

Who can participate

Age range

2 Hours – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.