Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder
NCT ID: NCT07079826
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-02-21
2026-08-31
Brief Summary
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Detailed Description
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This is a double-blind, sham-controlled, randomized pilot trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of the Sparrow Link device in hospitalized adults with OUD undergoing opioid withdrawal. The study is being conducted at UPMC Presbyterian and Montefiore hospitals with clinical oversight by the STARS (Substance Treatment and Recovery Service) addiction medicine consult team.
Eligible participants will be randomized 1:1 to receive either active or sham tAN stimulation. All participants will receive standard hospital-based opioid withdrawal management, including pharmacologic treatment as clinically indicated (e.g., methadone, buprenorphine, or full opioid agonists). The device is applied and monitored by trained research staff during daytime hours.
The study includes both implementation and effectiveness endpoints. Primary implementation outcomes include device usage consistency and early device discontinuation. The primary effectiveness outcome is change in opioid withdrawal severity, as measured by the Clinical Opiate Withdrawal Scale (COWS). The study also includes secondary measures of pain, anxiety, depressive symptoms, craving, heart rate variability, and opioid use during hospitalization. Exploratory outcomes include referral to follow-up care, intent to continue device use, and qualitative feedback from providers regarding device feasibility and integration into clinical workflow.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active tAN + Standard Care
Active tAN stimulation in addition to standard of care for opioid withdrawal management
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.
Sham tAN + Standard Care
Sham tAN stimulation in addition to standard of care for opioid withdrawal management
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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UPMC Ladies Hospital Aid Society
UNKNOWN
Payel Roy
OTHER
Responsible Party
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Payel Roy
Associate Professor
Principal Investigators
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Payel J Roy, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Payel J Roy, MD, MSc
Role: primary
Gagandeep S Shergill, MS
Role: backup
Related Links
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Study device link
Other Identifiers
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STUDY24050080
Identifier Type: -
Identifier Source: org_study_id