# Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS)

> **NIH NIH UG1** · INDIANA UNIVERSITY INDIANAPOLIS · 2021 · $468,862

## Abstract

PROJECT SUMMARY / ABSTRACT
The nationwide opioid epidemic includes women of child birthing age accounting for a dramatically
increased number of infants being born with neonatal opioid withdrawal syndrome (NOWS). Currently there
is no uniformly accepted treatment strategy for NOWS and the choice of primary medication, criteria for
treatment, and dosing/weaning schedules vary between centers. Morphine is by far the most commonly
used medication for NOWS treatment, followed by methadone. Buprenorphine is a promising drug but with
limited studied in this patient population. Additionally, the screening tools used to diagnose NOWS and the
appropriate threshold to initiate drug therapy have not been conclusively evaluated. When historical
empirically derived drug treatment and weaning protocols have been modified and standardized, reductions
of length of stay have been observed. Additionally, nonpharmalogical methods appear to be successful in
reducing the symptoms of NOWS. In this application we present preliminary data of a pilot randomized
controlled trial currently in progress in our nursery. It includes identifying infants with severe symptoms of
NOWS via modified Finnegan scoring, then randomizing them to a standard morphine dosing/weaning
schedule, or to an optimal morphine dosing strategy. The optimal morphine dosing strategy does not
provide a scheduled dose of morphine, but only provides a dose of morphine when the withdrawal
symptoms cannot be satiated through nonpharmacological means. Both study groups received all optimized
nonpharmacological methods available to them. In the optimal morphine arm, we observed a large
reduction in the use of morphine and in the duration of days receiving pharmacologic therapy. We speculate
that the use of the optimal morphine dosing strategy limited the use of pharmacologic treatment to only
times when nonpharmacologic interventions were not sufficient. This essentially provided the mother or
other care givers time to recognize and adapt to the infant's withdrawal behaviors, enabling them to
extinguish them via nonpharmacological means. The optimal morphine dosing strategy also prevented the
infant's withdrawal from becoming too symptomatic by allowing morphine to be used when needed, yet not
committing the infant to a prolonged scheduled course of morphine treatment and weaning when
nonpharmacological measures could have sufficed. Thus, we favor a clinical trial that emphasizes the use
of nonpharmacological methods to control withdrawal symptoms irrespective of the drug arm the infant is
assigned. However, we favor including a more novel optimal dosing strategy arm rather than limiting the
investigation to standard scheduled dosing/weaning arms.

## Key facts

- **NIH application ID:** 10380398
- **Project number:** 1UG1HD107653-01
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Gregory M. Sokol
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $468,862
- **Award type:** 1
- **Project period:** 2021-09-17 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10380398

## Citation

> US National Institutes of Health, RePORTER application 10380398, Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS) (1UG1HD107653-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10380398. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*