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

NCT07079826 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY24050080
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Withdrawal; Opioid Use Disorder (OUD)

Keywords

transcutaneous auricular neurostimulation; Sparrow Link; tAN; vagus nerve stimulation; trigeminal nerve stimulation; neuromodulation; Clinical Opiate Withdrawal Scale; opioid craving; inpatient addiction care; withdrawal management; Addiction Medicine; anxiety; depression

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 (7)

• Early Device Refusal Rate (Percentage)

  Day 1

• Device Discomfort Reported (Percentage)

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

• Technical Issue Rate (Percentage)

  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)

  Through study completion, an average of 5 days

• Intent to Engage in Care Rate (Percentage)

  Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).

Other Outcomes (7)

• Subjective Opioid Withdrawal Scale (SOWS)

  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)

  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)

  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).

Study Arms (2)

Active tAN + Standard Care

ACTIVE COMPARATOR

Active tAN stimulation in addition to standard of care for opioid withdrawal management

Device: Sparrow Link (Active tAN)

Sham tAN + Standard Care

SHAM COMPARATOR

Sham tAN stimulation in addition to standard of care for opioid withdrawal management

Device: Sparrow Link (Sham tAN)

Interventions

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.

Active tAN + Standard Care

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.

Sham tAN + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants must meet at least ONE of the following criteria:
• Are continuing to experience opioid withdrawal symptoms:
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Payel Roy: lead
• UPMC Ladies Hospital Aid Society: collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Study device link

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Payel J Roy, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Payel J Roy, MD, MSc

CONTACT

412-692-4473; payel.roy@pitt.edu

Gagandeep S Shergill, MS

CONTACT

412-577-8978; gas246@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 23, 2025
• Study Start: February 21, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)