Recruiting

Sparrow Link

Sponsor:

Payel Roy

Code:

NCT07079826

Conditions

Opioid Withdrawal

Opioid Use Disorder (OUD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sparrow Link (Active tAN)

Sparrow Link (Sham tAN)

Study Details

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)

Study ID

NCT07079826

Start date

May 27, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tAN + Standard Care

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

sham comparator: Sham tAN + Standard Care

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

Interventions

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.

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.

Primary outcome measure

  • Device Usage Consistency (Percentage of Expected Wear Time Achieved) [ 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) [ 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) [ 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) ]

Central Contacts and Locations

Central contacts

Payel J Roy, MD, MSc

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

Gagandeep S Shergill, MS

412-577-8978gas246@pitt.edu

Locations

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Payel J Roy, MD, MSc

4126924473payel.roy@pitt.edu

Gagandeep S Shergill, MS

4125778978gas246@pitt.edu

More Information

Sponsor

Payel Roy

Last update posted

Jun 1, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Payel Roy on 2026-06-01.