# Delivering Transcutaneous Auricular Neurostimulation to Improve Treatment Retention in Opioid Use Disorder

> **NIH NIH R44** · SPARK BIOMEDICAL INC · 2022 · $1,246,700

## Abstract

Currently, the United States is experiencing an opioid epidemic in the use of prescription and non-prescription
drugs that has continued to rise since the 1990’s. In 2005, there were an estimated 10 million chronic pain
participants receiving daily, long-term treatment with opioids. The continuing increase in opioid consumption
from 2005 to 2017 suggests that the number may now exceed 11 million. Unfortunately, the need for safe and
effective opioid withdrawal treatment is demanding and largely unmet.
A primary constraint on the overall percentage of pharmacotherapy treatment recipients is the limited availability
of licensed physicians that can prescribe opioid-based pharmacotherapies. Prescription opioids pose a variable
level of risk on respiratory depression and abnormal cardiac activity and can only be obtained from licensed
opioid treatment programs. In contrast, non-opioid pharmacotherapies (lofexidine and naltrexone) do not require
a license, and have the potential to be more widely administered. However, the treatment efficacy and retention
of these medications are limited, thus significantly fewer patients utilize non-opioid vs opioid pharmacotherapies.
Due to inadequate and scarce treatment options finding an effective, non-pharmacological approach that would:
1) require minimal training, 2) be readily available to physicians and advanced care providers, 3) have a minimal
side effects profile, 4) prevent or eliminate the use of opioids, and 5) remove the fear of experiencing
acute/precipitated withdrawal would be critical in improving and expanding treatment for opioid addiction.
Abundant clinical evidence exists for the rapid and effective reduction of signs and symptoms associated with
opioid withdrawal through various approaches of non-invasive neurostimulation.
We propose using transcutaneous auricular neurostimulation (tANTM) as an adjuvant to non-opioid
pharmacotherapies to improve treatment retention by further reducing opioid withdrawal symptoms and cravings.
Spark Biomedical Inc., has developed a tAN system, that removes the limitations of percutaneous
neurostimulation systems. Spark’s SparrowTM Therapy System utilizes a flexible Earpiece with embedded
hydrogel electrodes that adhere to the skin, the Earpiece is disposable after use, and delivers a more comfortable
and practical therapy. Additionally, this system is capable of fully customizing stimulation parameters to match
each participants’ therapeutic requirements. It was hypothesized that activating auricular cranial nerve branches
via tAN would confer a similar reduction in opioid withdrawal symptoms, minus the drawbacks of percutaneous
neurostimulation.
The Sparrow System is a wearable, battery-operated, neurostimulation device intended to transcutaneously
stimulate nerves in and/or around the ear. The Sparrow is currently indicated as a transcutaneous nerve
stimulator that aids in the reduction of opioid withdrawal symptoms. The goal of this proposed effort is to expa...

## Key facts

- **NIH application ID:** 10456147
- **Project number:** 5R44DA053876-02
- **Recipient organization:** SPARK BIOMEDICAL INC
- **Principal Investigator:** Navid Khodaparast
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,246,700
- **Award type:** 5
- **Project period:** 2021-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10456147

## Citation

> US National Institutes of Health, RePORTER application 10456147, Delivering Transcutaneous Auricular Neurostimulation to Improve Treatment Retention in Opioid Use Disorder (5R44DA053876-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10456147. Licensed CC0.

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