Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder

Summary

This study is evaluating the Sparrow Link, a wearable device that delivers gentle electrical signals to nerves in the outer ear (a technique known as transcutaneous auricular neurostimulation, or tAN). The goal is to assess whether the device is feasible to use, acceptable to patients, and may help reduce opioid withdrawal symptoms in hospitalized adults being treated for opioid use disorder (OUD). Participants will be randomly assigned to receive either the active device or a sham (inactive) version. Neither participants nor their clinical teams will know which version is used. All participants will continue receiving standard hospital care for opioid withdrawal. Researchers will collect information on how long participants use the device, whether they stop using it early, and changes in withdrawal severity. The study will also examine pain, craving, mood, anxiety, heart rate variability, and opioid use during hospitalization.

Eligibility

Inclusion Criteria:

Eligible participants must meet at least ONE of the following criteria:

1. Are continuing to experience opioid withdrawal symptoms:

   1. Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications,

      or
   2. During tapering or detox from full agonist opioids.

   OR
2. Have chosen to decline methadone or buprenorphine but still require support for withdrawal symptoms and/or pain management.

Additionally, participants must:

* Be 18 years old or older.
* Have active history of opioid use disorder.
* Have a COWS score between 5-24 (Mild-moderate opioid withdrawal), indicating residual withdrawal symptoms.
* Be able to provide informed consent.

Exclusion Criteria:

* History of or active seizure disorder.
* Presence of a cardiac device (e.g., pacemaker, defibrillator).
* Presence of a neurostimulator (e.g., deep brain stimulator, spinal cord stimulator).
* Pregnant or lactating individuals.
* COWS score ≥ 25 (Severe Withdrawal), requiring medical stabilization.
* Abnormal ear Anatomy, ear Infections, or skin Conditions at Electrode Sites, including congenital malformations, post-surgical changes, significant scarring, open wounds, or hypersensitivity.
* Active neurological disorders, such as traumatic brain injury, stroke, multiple sclerosis, or other conditions that may interfere with neurostimulation effects or autonomic regulation as assessed at the investigator's discretion.
* Severe alcohol or benzodiazepine withdrawal that is not adequately controlled with medication, per investigator discretion.
* Known or documented allergy to hydrocolloid adhesives, as evidenced in the medical record.
* Evidence of active psychosis, as documented in the medical record or reported by clinical staff.
* Non-English speakers, whose limited English proficiency precludes informed consent or meaningful participation in study assessments validated only in English.

Conditions4

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