# Improving Buprenorphine Retention with Transcutaneous Auricular Neurostimulation for Patients with Co-occurring Posttraumatic Stress Disorder and Opioid Use Disorder

> **NIH NIH UG3** · UNIVERSITY OF CINCINNATI · 2024 · $306,133

## Abstract

PROJECT SUMMARY
Background. Buprenorphine (BUP) is an effective medication for opioid use disorder (OUD) but dropout rates
are high during the stabilization phase (months 1-3). Posttraumatic stress disorder (PTSD) is common in
individuals with OUD and makes retention in treatment even more challenging because of hyperarousal and
intense negative affect that greatly increase risk for urges to “self-medicate”. Transcutaneous auricular
neurostimulation (tAN) of the vagus nerve has shown promise for alleviating symptoms of PTSD and opioid
withdrawal symptoms (OWS) but its effects have yet to be tested in a sample starting BUP therapy with these
co-occurring concerns.
Aims. We will conduct an open-label trial (Aim 1; 2-year UG3; N = 20) of the Sparrow Ascent System—a
patient-administered, ear worn device that delivers electrical stimulation to branches of the vagus and
trigeminal nerves—to evaluate the acceptability, tolerability, and feasibility of tAN for patients with co-occurring
PTSD/OUD in the context of BUP initiation. We anticipate that more than 50% of the sample will be retained in
BUP. Using data from the UG3 study, we will complete FDA pre-submission for the proposed UH3 study to
support a PTSD/OUD indication for Sparrow (Aim 2). Then, we will conduct a randomized, intent-to-treat,
sham-controlled Phase II clinical trial (Aim 3; 3-year UH3; N = 60) testing the effects of tAN on BUP retention
among PTSD/OUD patients to obtain realistic estimates of tAN’s effect size and inform development of a
subsequent full-scale clinical trial. We anticipate that active tAN will improve BUP retention relative to sham.
Methods. For both studies, we will recruit patients initiating BUP treatment in a community-based clinic and
confirm their PTSD/OUD diagnostic status using gold-standard measures. Patients will begin using the
Sparrow Ascent device within one week of BUP induction. Participants in the open-label (UG3) study and
active tAN (UH3) conditions will receive therapeutic stimulation from Sparrow; those in the sham condition
(UH3) will not. During the open-label trial, we will collect self- and provider-reported tolerability and feasibility
data. For both studies, we will obtain self-reported and UDS-confirmed substance use, BUP and Sparrow
compliance, and self-reported PTSD and OWS severity at weekly research visits over the 3-month active study
period.
Outcomes. The primary outcome in the UG3 and UH3 studies will be 3-month BUP retention (retained/not
retained) as defined by current BUP prescription at the time of data extraction. Key secondary outcomes for
the UG3 trial include the acceptability, tolerability, and feasibility of the Sparrow device as an adjunct
intervention alleviating symptoms of PTSD and OWS for patients initiating BUP. Key secondary outcomes for
the randomized Phase II clinical trial will include weekly substance use with timeline follow-back and UDS
results, PTSD symptom severity, opioid withdrawal and craving, and quality of...

## Key facts

- **NIH application ID:** 10936531
- **Project number:** 5UG3DA059409-02
- **Recipient organization:** UNIVERSITY OF CINCINNATI
- **Principal Investigator:** Joel Gregory Sprunger
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $306,133
- **Award type:** 5
- **Project period:** 2023-09-30 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10936531

## Citation

> US National Institutes of Health, RePORTER application 10936531, Improving Buprenorphine Retention with Transcutaneous Auricular Neurostimulation for Patients with Co-occurring Posttraumatic Stress Disorder and Opioid Use Disorder (5UG3DA059409-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10936531. Licensed CC0.

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