# Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome

> **NIH NIH R44** · SPARK BIOMEDICAL INC · 2022 · $1,248,001

## Abstract

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition in which infants undergo withdrawal after
exposure to prescription or non-prescription opioids such as methadone or heroin in utero. NOWS babies exhibit
hyperirritability of the central nervous system and respiratory, gastrointestinal, and autonomic symptoms. These
symptoms usually appear within 48 to 72 hours after birth. As of 2012, an infant with NOWS was born every 25
minutes in the US, accounting for more than $1.5 billion in national healthcare expenditures. Between 2000–
2012, national rates of NOWS increased 383% from 1.2 per 1000 births to 5.8 per 1000 births. These infants
frequently require hospital stay in a neonatal intensive care unit (NICU) with an average hospital stay of 25 days
at an average treatment cost of $66K.
Currently, no nationwide standard of care exists for managing NOWS. Treatment of NOWS usually follows a
multimodal regime centered on controlled withdrawal and replacement drug therapy with oral morphine.
However, treatments that reduce the need for neurotoxic opioids are a high priority in this vulnerable population.
In fact, a large multicenter randomized study of 898 infants demonstrated that, although morphine is effective in
decreasing clinical signs of pain, it can cause significant acute adverse effects such as changes in heart and
respiratory rate, hypotension, nasogastric feeds, and need for intravenous supplemental nutrition. Based on the
vulnerability of the population and the potential for adverse effects, morphine should be used judiciously and
cautiously.
The American Academy of Pediatrics recommends attempting the use of non-pharmacologic treatment, which
includes placing the infant in a dark and quiet environment, swaddling, rocking, breastfeeding, and providing
high-calorie nutrition in frequent small feedings (known as Eat, Sleep, Console or ESC), among other techniques.
When used appropriately, such non-pharmacological interventions have resulted in a reduction in length of stay,
length of treatment (LOT), and percentage of infants requiring pharmacotherapy. With NOWS babies already
under stress from opioid withdrawal, a non-pharmacological treatment may greatly benefit these patients,
lowering the need for additional medications and potentially reducing their hospital stay.
Our Phase I effort was the first study investigating the effects of transcutaneous auricular neurostimulation (tAN),
as an adjunct therapy to oral morphine, in the reduction of the opioid withdrawal signs and symptoms in newborns
with NOWS. Across all study participants, tAN was shown to be safe, well-tolerated, and facilitate the rapid
weaning of oral morphine. If proven safe and effective in future trials, tAN may expand non-pharmacological
treatment options for these infants. Building on our Phase I success, we propose to use our Roo™ tAN system
as an adjunct therapy to reduce the signs and symptoms associated with NOWS.

## Key facts

- **NIH application ID:** 10491343
- **Project number:** 5R44DA050360-03
- **Recipient organization:** SPARK BIOMEDICAL INC
- **Principal Investigator:** DOROTHEA DENISE JENKINS
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,248,001
- **Award type:** 5
- **Project period:** 2019-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10491343

## Citation

> US National Institutes of Health, RePORTER application 10491343, Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome (5R44DA050360-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10491343. Licensed CC0.

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