NCT07079826

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

Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Payel Roy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Opioid withdrawal is a major barrier to the initiation and continuation of treatment for opioid use disorder (OUD), particularly during hospitalization. Symptoms of withdrawal may lead patients to decline initiation of treatment or leave against medical advice. Neuromodulation strategies, such as transcutaneous auricular neurostimulation (tAN), are emerging as potential adjuncts to standard pharmacologic management. tAN targets cranial nerves via stimulation of the auricular branch of the vagus nerve and other nerve branches in the external ear. The Sparrow Link is a wearable tAN device intended for short-term use in clinical environments and is being evaluated in this study for its role in reducing withdrawal symptoms and enhancing the inpatient care experience. This is a double-blind, sham-controlled, randomized pilot trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of the Sparrow Link device in hospitalized adults with OUD undergoing opioid withdrawal. The study is being conducted at UPMC Presbyterian and Montefiore hospitals with clinical oversight by the STARS (Substance Treatment and Recovery Service) addiction medicine consult team. Eligible participants will be randomized 1:1 to receive either active or sham tAN stimulation. All participants will receive standard hospital-based opioid withdrawal management, including pharmacologic treatment as clinically indicated (e.g., methadone, buprenorphine, or full opioid agonists). The device is applied and monitored by trained research staff during daytime hours. The study includes both implementation and effectiveness endpoints. Primary implementation outcomes include device usage consistency and early device discontinuation. The primary effectiveness outcome is change in opioid withdrawal severity, as measured by the Clinical Opiate Withdrawal Scale (COWS). The study also includes secondary measures of pain, anxiety, depressive symptoms, craving, heart rate variability, and opioid use during hospitalization. Exploratory outcomes include referral to follow-up care, intent to continue device use, and qualitative feedback from providers regarding device feasibility and integration into clinical workflow.

Conditions

• Opioid Withdrawal
• Opioid Use Disorder (OUD)

Interventions

Type	Name	Description
DEVICE	Sparrow Link (Active tAN)	Participants will receive the Sparrow Link device with active transcutaneous auricular neurostimulation (tAN) in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated.
DEVICE	Sparrow Link (Sham tAN)	Participants will receive the Sparrow Link device with sham (non-active) stimulation in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated.

Timeline

• Start date: 2026-09-21
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-07-23
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study