An interventional study of Sparrow Link (Active tAN) and Sparrow Link (Sham tAN) in Opioid Withdrawal and Opioid Use Disorder (OUD), sponsored by Payel Roy. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Payel Roy · Not applicable, Interventional, and Treatment
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 50 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Payel Roy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Eligible participants must meet at least ONE of the following criteria:
Are continuing to experience opioid withdrawal symptoms:
Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications,
or
OR
Additionally, participants must:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active tAN stimulation in addition to standard of care for opioid withdrawal management
Device: Sparrow Link (Active tAN)
Sham tAN stimulation in addition to standard of care for opioid withdrawal management
Device: Sparrow Link (Sham 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.
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.
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).
Subjective Opioid Withdrawal Scale (SOWS)
16-item participant-reported scale (0-64) assessing withdrawal severity.
Time frame: Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).
Numeric Pain Rating Scale (NPRS)
Participant-reported pain severity (0-10).
Time frame: Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).
Opioid Craving Scale (OCS-3)
3-item scale measuring craving frequency, intensity, and situational response (0-30 total).
Time frame: Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).
STAI-S (State-Trait Anxiety Inventory - State)
20-item scale measuring state anxiety (range 20-80).
Time frame: Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).
MADRS (Montgomery-Åsberg Depression Rating Scale)
Clinician-rated 10-item depression severity scale (0-60 total).
Time frame: Assessed at baseline and final study assessment (Day 5 or early discontinuation).
Heart Rate Variability (HRV)
RMSSD from 5-min resting ECG using wrist wearable; reflects autonomic tone.
Time frame: Pre-device baseline, 1-hour post-device, 2- hour post device, and end-of-day on Day 1; then pre-device, 1- hour post-device, end-of-day on Days 2-5 or until study exit (up to 5 days).
Mean MME per 24-Hour Period Anchored to Device Wear (Normalized)
Mean morphine milligram equivalents (MME) administered per 24-hour window anchored to device placement time. Normalized using: (Total MME divided by hours covered) times 24.
Time frame: Day 0 through up to Day 5
Plan to share: No — Individual Participant Data (IPD) from this early-phase feasibility study will not be shared due to participant confidentiality concerns, consent limitations, and the exploratory nature of the trial. Given the small sample size and potential re-identifiability of participants, especially within a high-risk inpatient population, sharing IPD could pose privacy risks. Additionally, the consent form does not explicitly authorize future data sharing, and the study's non-powered design limits generalizability of individual-level findings.
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