Sparrow Link device to help with opioid withdrawal in hospitalized adults with OUD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled pilot trial evaluating the Sparrow Link transcutaneous auricular neurostimulation device in hospitalized adults with opioid withdrawal. Participants are assigned to active or sham stimulation in addition to standard withdrawal management. The study measures feasibility, acceptability, withdrawal severity, pain, craving, mood, anxiety, heart rate variability, and in-hospital opioid use. It is conducted at UPMC Presbyterian and Montefiore with oversight from a dedicated addiction medicine team. The goal is to see if short-term tAN stimulation is a practical and potentially helpful adjunct to pharmacologic treatment for OUD in the inpatient setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• UPMC Presbyterian
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Payel J Roy, MD, MSc — University of Pittsburgh
• Study coordinator: Payel J Roy, MD, MSc
• Email: payel.roy@pitt.edu
• Phone: 412-692-4473

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.