# An Innovative Intervention for OUD Treatment

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2020 · $774,845

## Abstract

This application proposes to conduct a randomized, controlled clinical trial to test the efficacy and safety of the
Bridge Device (BD) when used for the treatment of opioid withdrawal. The BD is an FDA cleared tool that is
currently marketed for the treatment of opioid withdrawal; preliminary evidence suggests it is effective and has
a low risk for adverse effects. However, the product has not been tested against a sham control condition when
used for opioid withdrawal treatment. Descriptive data provide evidence that it has effectiveness in suppressing
opioid withdrawal, but there is a need to test the device under controlled conditions. In addition to testing the
BD to a sham condition (SBD), the study includes a third condition – lofexidine. This is an FDA-approved
medication for the treatment of opioid withdrawal, and this study will be the first direct comparison of two
available non-mu opioid approaches that can be used to help transition patients off of opioid physical
dependence. Novel mechanisms that assist in transitioning a person from physical dependence on opioids to a
non-dependent state are needed – to address a patient-centered desire to live without maintenance on opioid
agonist treatment (OAT), and/or to aid in the transition to antagonist treatment. Given the accumulating
evidence for the efficacy of naltrexone (NTX), and especially extended release NTX, new and innovative ways
to help patient stabilize on antagonist treatment are needed. The BD may serve a useful role in this process.
The device is a percutaneous nerve field stimulator that has 4 electrodes placed on/near the ear, with wires to
a small device that is worn behind the ear. The device targets 4 cranial nerves (V, VII, IX, and X) that have
auricular branches, and it provides alternating low-grade electrical frequencies to these nerves as a means for
peripheral stimulation of the specific cranial nerves. Stimulation by the device is hypothesized to provide
central nervous modulation of pain paths. When used clinically, the device is worn continuously for 5 days, and
reports of its use indicate that it provides relief of opioid withdrawal within approximately an hour of placement.
The primary goal of this study is to demonstrate that the BD is more effective than a sham control condition in
suppressing opioid withdrawal signs and symptoms, and a secondary aim is to determine its relative efficacy
compared to lofexidine. Participants will be persons physically dependent on opioids, with a diagnosis of OUD,
and who agree to reside on a residential unit for the study duration. At the end of the residential stay,
participants will be offered oral naltrexone treatment, and the option of transition on to XR-NTX. Given the
magnitude of the opioid crisis in the United States, and the need to both expand treatment options as well as
mechanisms that can facilitate the transition on to antagonist treatments, the BD has the potential to have
substantial impact and public health...

## Key facts

- **NIH application ID:** 9962630
- **Project number:** 1R01DA048761-01A1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Eric C. Strain
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $774,845
- **Award type:** 1
- **Project period:** 2020-08-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9962630

## Citation

> US National Institutes of Health, RePORTER application 9962630, An Innovative Intervention for OUD Treatment (1R01DA048761-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9962630. Licensed CC0.

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