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

ConditionsOpioid Withdrawal Opioid Use Disorder (OUD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPayel Roy

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

During tapering or detox from full agonist opioids.

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

Be 18 years old or older.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Sparrow Link (Active tAN)
Device
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.
Sparrow Link (Sham tAN)
Device
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Active tAN + Standard CareActive comparator 1 intervention

Group B: Sham tAN + Standard CareSham comparator 1 intervention

Trial outcomes

Primary outcomes

Device Usage Consistency (Percentage of Expected Wear Time Achieved)

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.

Time frame

From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

Early Device Discontinuation (Percentage of Participants)

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.

Time frame

From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

Clinical Opiate Withdrawal Scale (COWS)

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.

Time frame

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)

Secondary outcomes

Early Device Refusal Rate (Percentage)

Proportion of randomized participants who decline to initiate device use after allocation.

Time frame

Day 1

Device Discomfort Reported (Percentage)

Proportion of participants reporting discomfort or physical side effects while wearing the device, regardless of discontinuation.

Time frame

From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

Technical Issue Rate (Percentage)

Proportion of participants in the active arm who experience one or more technical issues (e.g., stimulation interruption, electrode detachment, app malfunction).

Time frame

From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).

Referral to Follow-Up Care Rate (Percentage)

Proportion of participants discharged (planned or unplanned) with a documented referral to outpatient treatment (Medications for Opioid Use Disorder, Medication-Assisted Treatment, or other follow-up addiction treatment.)

Time frame

Through study completion, an average of 5 days

Other outcomes

Subjective Opioid Withdrawal Scale (SOWS)

16-item participant-reported scale (0-64) assessing withdrawal severity.

Time frame

Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).

Numeric Pain Rating Scale (NPRS)

Participant-reported pain severity (0-10).

Time frame

Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).

Opioid Craving Scale (OCS-3)

3-item scale measuring craving frequency, intensity, and situational response (0-30 total).

Time frame

Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).

STAI-S (State-Trait Anxiety Inventory - State)

20-item scale measuring state anxiety (range 20-80).

Time frame

Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Payel Roy

Lead sponsor

University of Pittsburgh

Sponsor institution

UPMC Ladies Hospital Aid Society

Collaborator

Source ClinicalTrials.gov

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