# HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site

> **NIH NIH UG1** · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · 2024 · $222,694

## Abstract

Project Summary/Abstract
The Neonatal Opioid Withdrawal Syndrome (NOWS) Pharmacological Treatments Comparative
Effectiveness Trial is a multisite study that examine the long- and short-term outcomes for neonates with
NOWS that require pharmacological treatment. The neonates will be randomized to three medications:
buprenorphine, methadone and morphine. Short term outcomes are anticipated to include length of hospital
stay and length of pharmacological treatment, with longer term outcomes including neonatal growth and
neurodevelopment. The common protocol will be developed by a steering committee composed of the
principal investigators from each participating clinical center. The trial will be designed to control for relevant
clinical variables including the type of maternal opioid used, maternal polysubstance use including tobacco,
the use of nonpharmacological treatments for NOWS, and the use of adjunctive nonopioid medications. The
follow-up plan will be developed as part of the protocol and will extend until at least 24 months of age and
include the use of specific neurodevelopmental assessment tools including the Bayley Scales of Infant and
Toddler Development 4th Edition. The trial is designed to determine the optimal pharmacological treatment
including the specific medication dosing and weaning regimen. The University of New Mexico Clinical Center
will include infants treated for NOWS across all neonatal care sites including the mother baby unit where
dyadic room-in care is provided, the intermediate care nursery, and the neonatal intensive care unit. The
standardization of pharmacological treatment for NOWS is anticipated to have significant public health
benefits including decreasing length of hospital stay, decreasing cost of treatment, and potentially improving
long term neurodevelopmental outcomes.

## Key facts

- **NIH application ID:** 10917399
- **Project number:** 5UG1HD107627-03
- **Recipient organization:** UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
- **Principal Investigator:** LAWRENCE M LEEMAN
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $222,694
- **Award type:** 5
- **Project period:** 2021-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10917399

## Citation

> US National Institutes of Health, RePORTER application 10917399, HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site (5UG1HD107627-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10917399. Licensed CC0.

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