Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)
Payel Roy
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.
Description
Opioid withdrawal is a major barrier to the initiation and continuation of treatment for opioid use disorder (OUD), particularly during hospitalization. Symptoms of withdrawal may lead patients to decline initiation of treatment or leave against medical advice. Neuromodulation strategies, such as transcutaneous auricular neurostimulation (tAN), are emerging as potential adjuncts to standard pharmacologic management. tAN targets cranial nerves via stimulation of the auricular branch of the vagus nerve and other nerve branches in the external ear. The Sparrow Link is a wearable tAN device intend…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sc…
Interventions
- DeviceSparrow 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.
- DeviceSparrow 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.
Location
- UPMC PresbyterianPittsburgh, Pennsylvania