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.
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 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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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.
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.
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Device Usage Consistency (Percentage of Expected Wear Time Achieved)
Device usage consistency is defined as the total number of hours the device was actively worn divided by the total number of hours the device was expected to be worn, multiplied by 100. Calculated using stimulation logs and staff-logged application/removal times.
Time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Early Device Discontinuation (Percentage of Participants)
Proportion of participants who permanently discontinue device use prior to reaching protocol-defined endpoints: (1) meeting 3 of 4 clinical criteria, (2) completion of 5 study days, or (3) hospital discharge. Calculated as number discontinued divided by number who initiated use times 100.
Time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Clinical Opiate Withdrawal Scale (COWS)
Opioid withdrawal severity using the Clinical Opiate Withdrawal Scale (COWS), an 11-item clinician-rated tool with scores ranging from 0-48. The primary outcome is change from pre-device baseline to 1-hour post-device placement. Higher COWS scores indicate greater opioid withdrawal severity.
Time frame: Pre-device baseline, 1-hour post-initiation, 2-hour post-initiation, and end-of-day on Day 1; then on each subsequent device wear day (Days 2-5 or until study exit), at three timepoints: pre-device, 1-hour post-device, and end-of-day (up to 5 days total)
Early Device Refusal Rate (Percentage)
Proportion of randomized participants who decline to initiate device use after allocation.
Time frame: Day 1
Device Discomfort Reported (Percentage)
Proportion of participants reporting discomfort or physical side effects while wearing the device, regardless of discontinuation.
Time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Technical Issue Rate (Percentage)
Proportion of participants in the active arm who experience one or more technical issues (e.g., stimulation interruption, electrode detachment, app malfunction).
Time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Referral to Follow-Up Care Rate (Percentage)
Proportion of participants discharged (planned or unplanned) with a documented referral to outpatient treatment (Medications for Opioid Use Disorder, Medication-Assisted Treatment, or other follow-up addiction treatment.)
Time frame: Through study completion, an average of 5 days
Intent to Engage in Care Rate (Percentage)
Proportion of participants who express intent to attend follow-up treatment post-discharge.
Time frame: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Post-Discharge Engagement Composite (Percentage)
Composite outcome defined as presence of either: (a) documented referral or (b) participant-reported intent to engage in care.
Time frame: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Desire to Continue Device Use (Percentage) - Active Arm Only
Proportion of active-arm participants expressing desire to use the device again in the future for opioid withdrawal management.
Time frame: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
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