CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 189 enrolled / 189 target
Drug / intervention
Morphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04214834
NCT04214834Phase 3ActiveUpdate Overdue (2.7/mo)Completion was 29mo ago
CompareCT.gov

Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program·interventional·Posted Jan 2, 2020·Updated Jun 30, 2026

In Brief

A Phase 3 clinical trial evaluating Morphine and Methadone for Neonatal Opioid Withdrawal Syndrome. Active but no longer recruiting, targeting 189 participants across 24 sites.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Opioid Withdrawal Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3ActiveOverdue
2020202120222023202420252026
First PostedJan 2, 2020
Enrollment StartSep 28, 2020
Primary CompletionJan 31, 2024
Study CompletionJun 30, 2026
TodayJul 1, 2026
Enrollment to primary: 3.3 yearsPosted 6.5 years ago

Arms & Interventions

Rapid-weanactive_comparator

15% decrements from the stabilization dose of morphine/methadone

Drug: MorphineDrug: Methadone
Slow-weanactive_comparator

10% decrements from the stabilization dose of morphine/methadone

Drug: MorphineDrug: Methadone

Interventions

Morphinedrug

The dose interval for morphine will be either every 3 or 4 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.

Methadonedrug

The dose interval for methadone will be every 8 or 12 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.