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Sparrow Link Device for Opioid Withdrawal in Hospitalized Adults

This study is testing a wearable device called Sparrow Link, which uses gentle electrical signals (transcutaneous auricular neurostimulation, or tAN) on the outer ear. It aims to see if the device can help reduce opioid withdrawal symptoms in adults hospitalized for opioid use disorder (OUD). You might be eligible if you are still experiencing withdrawal symptoms despite standard medical care (like methadone or buprenorphine), or if you are tapering off opioids. Participants will receive either the active Sparrow Link device or a non-active (sham) version, along with their usual hospital care. Neither you nor your care team will know which device you receive. Researchers will look at how consistently the device is worn, if people stop using it early, and changes in withdrawal symptoms.

Study design
This is a double-blind, sham-controlled, randomized pilot study with 50 participants. This means participants are randomly assigned to receive either the active device or a non-active (sham) device, and neither they nor their doctors will know which one they are receiving.
What's involved
You would wear the Sparrow Link device for up to 5 days. Your withdrawal symptoms will be assessed multiple times on the first day and then daily for up to 5 days.
Compensation
Not stated in the trial record.
Follow-up
Your device usage and withdrawal symptoms will be monitored for up to 5 days, or until you stop using the device early.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07079826

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

Recruiting
NAAges 18+InterventionalTreatment
Payel Roy
~50 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Sparrow Link (Active tAN)Sparrow Link (Sham tAN)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Usage Consistency (Percentage of Expected Wear Time Achieved)
Measured over From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
+2 more outcomes measured

Conditions

Opioid Withdrawal
Opioid Use Disorder (OUD)

Explore related trials

Opioid Use DisorderOpioid withdrawal

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Payel J Roy, MD, MSc · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Payel J Roy, MD, MSc
[email protected]
412-692-4473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Device Usage Consistency (Percentage of Expected Wear Time Achieved)From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

    Device usage consistency is defined as the total number of hours the device was actively worn divided by the total number of hours the device was expected to be worn, multiplied by 100. Calculated using stimulation logs and staff-logged application/removal times.

  • Early Device Discontinuation (Percentage of Participants)From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

    Proportion of participants who permanently discontinue device use prior to reaching protocol-defined endpoints: (1) meeting 3 of 4 clinical criteria, (2) completion of 5 study days, or (3) hospital discharge. Calculated as number discontinued divided by number who initiated use times 100.

  • Clinical Opiate Withdrawal Scale (COWS)Pre-device baseline, 1-hour post-initiation, 2-hour post-initiation, and end-of-day on Day 1; then on each subsequent device wear day (Days 2-5 or until study exit), at three timepoints: pre-device, 1-hour post-device, and end-of-day (up to 5 days total)

    Opioid withdrawal severity using the Clinical Opiate Withdrawal Scale (COWS), an 11-item clinician-rated tool with scores ranging from 0-48. The primary outcome is change from pre-device baseline to 1-hour post-device placement. Higher COWS scores indicate greater opioid withdrawal severity.