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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Payel Roy
Study ID
NCT07079826
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder (OUD)
  • Opioid Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 27, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC PresbyterianPittsburghPennsylvania15213
Payel J Roy, MD, MSc
[email protected]
4126924473
Gagandeep S Shergill, MS
[email protected]
4125778978

Find similar trials in Pittsburgh, PA

By research site
UPMC Presbyterian· Pittsburgh, PA

Related Studies