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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

PA