[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07079826":3,"trial-entities:NCT07079826":150,"trial-summary:NCT07079826":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":54,"secondary_outcomes":66,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":15,"eligibility_criteria":94,"std_ages":113,"locations":116,"central_contacts":136,"overall_officials":141,"references":145,"see_also_links":146},"NCT07079826","STUDY24050080","Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder","Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)","RECRUITING","2027-12","2026-05","2026-06-01","2026-05-27","Payel Roy","OTHER",false,"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.\n\nThis 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.\n\nEligible 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.\n\nThe 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.",[19,20],"Opioid Withdrawal","Opioid Use Disorder (OUD)",[22,23,24,25,26,27,28,29,30,31,32,33,34],"transcutaneous auricular neurostimulation","Sparrow Link","tAN","vagus nerve stimulation","trigeminal nerve stimulation","neuromodulation","Clinical Opiate Withdrawal Scale","opioid craving","inpatient addiction care","withdrawal management","Addiction Medicine","anxiety","depression","INTERVENTIONAL","TREATMENT",[38],"NA",{"count":40,"type":41},50,"ESTIMATED",[43,49],{"type":44,"name":45,"description":46,"armGroupLabels":47},"DEVICE","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.",[48],"Active tAN + Standard Care",{"type":44,"name":50,"description":51,"armGroupLabels":52},"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.",[53],"Sham tAN + Standard Care",[55,59,62],{"measure":56,"description":57,"timeFrame":58},"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\u002Fremoval times.","From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).",{"measure":60,"description":61,"timeFrame":58},"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.",{"measure":63,"description":64,"timeFrame":65},"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.","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)",[67,71,74,77,81,85,88],{"measure":68,"description":69,"timeFrame":70},"Early Device Refusal Rate (Percentage)","Proportion of randomized participants who decline to initiate device use after allocation.","Day 1",{"measure":72,"description":73,"timeFrame":58},"Device Discomfort Reported (Percentage)","Proportion of participants reporting discomfort or physical side effects while wearing the device, regardless of discontinuation.",{"measure":75,"description":76,"timeFrame":58},"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).",{"measure":78,"description":79,"timeFrame":80},"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.)","Through study completion, an average of 5 days",{"measure":82,"description":83,"timeFrame":84},"Intent to Engage in Care Rate (Percentage)","Proportion of participants who express intent to attend follow-up treatment post-discharge.","Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).",{"measure":86,"description":87,"timeFrame":84},"Post-Discharge Engagement Composite (Percentage)","Composite outcome defined as presence of either: (a) documented referral or (b) participant-reported intent to engage in care.",{"measure":89,"description":90,"timeFrame":84},"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.","ALL","18 Years",null,{"inclusion":95,"exclusion":100,"raw_text":112},[96,97,98,99],"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.",[101,102,103,104,105,106,107,108,109,110,111],"History of or active seizure disorder.","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.","Inclusion Criteria:\n\nEligible participants must meet at least ONE of the following criteria:\n\n1. Are continuing to experience opioid withdrawal symptoms:\n\n   1. Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications,\n\n      or\n   2. During tapering or detox from full agonist opioids.\n\n   OR\n2. Have chosen to decline methadone or buprenorphine but still require support for withdrawal symptoms and\u002For pain management.\n\nAdditionally, participants must:\n\n* Be 18 years old or older.\n* Have active history of opioid use disorder.\n* Have a COWS score between 5-24 (Mild-moderate opioid withdrawal), indicating residual withdrawal symptoms.\n* Be able to provide informed consent.\n\nExclusion Criteria:\n\n* History of or active seizure disorder.\n* Presence of a cardiac device (e.g., pacemaker, defibrillator).\n* Presence of a neurostimulator (e.g., deep brain stimulator, spinal cord stimulator).\n* Pregnant or lactating individuals.\n* COWS score ≥ 25 (Severe Withdrawal), requiring medical stabilization.\n* Abnormal ear Anatomy, ear Infections, or skin Conditions at Electrode Sites, including congenital malformations, post-surgical changes, significant scarring, open wounds, or hypersensitivity.\n* 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.\n* Severe alcohol or benzodiazepine withdrawal that is not adequately controlled with medication, per investigator discretion.\n* Known or documented allergy to hydrocolloid adhesives, as evidenced in the medical record.\n* Evidence of active psychosis, as documented in the medical record or reported by clinical staff.\n* Non-English speakers, whose limited English proficiency precludes informed consent or meaningful participation in study assessments validated only in English.",[114,115],"ADULT","OLDER_ADULT",[117],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":133},"UPMC Presbyterian","Pittsburgh","Pennsylvania","15213","United States",[124,129],{"name":125,"role":126,"phone":127,"email":128},"Payel J Roy, MD, MSc","CONTACT","4126924473","payel.roy@pitt.edu",{"name":130,"role":126,"phone":131,"email":132},"Gagandeep S Shergill, MS","4125778978","gas246@pitt.edu",{"lat":134,"lon":135},40.44062,-79.99589,[137,139],{"name":125,"role":126,"phone":138,"email":128},"412-692-4473",{"name":130,"role":126,"phone":140,"email":132},"412-577-8978",[142],{"name":125,"affiliation":143,"role":144},"University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[],[147],{"label":148,"url":149},"Study device link","https:\u002F\u002Fwww.sparkbiomedical.com\u002Fresearch\u002Fsparrow-link",{"nct_id":4,"conditions":151,"biomarkers":154},[152,153],"Opioid Use Disorder","Opioid withdrawal",[],{"nct_id":4,"found":156,"summary":157,"prompt_version":167},true,{"design":158,"status":159,"heading":160,"summary":161,"follow_up":162,"word_count":163,"commitments":164,"compensation":165,"drugs_mentioned":166},"This is a double-blind, sham-controlled, randomized pilot study with 50 participants. This means participants are randomly assigned to receive either the active device or a non-active (sham) device, and neither they nor their doctors will know which one they are receiving.","completed","Sparrow Link Device for Opioid Withdrawal in Hospitalized Adults","This study is testing a wearable device called Sparrow Link, which uses gentle electrical signals (transcutaneous auricular neurostimulation, or tAN) on the outer ear. It aims to see if the device can help reduce opioid withdrawal symptoms in adults hospitalized for opioid use disorder (OUD). You might be eligible if you are still experiencing withdrawal symptoms despite standard medical care (like methadone or buprenorphine), or if you are tapering off opioids. Participants will receive either the active Sparrow Link device or a non-active (sham) version, along with their usual hospital care. Neither you nor your care team will know which device you receive. Researchers will look at how consistently the device is worn, if people stop using it early, and changes in withdrawal symptoms.","Your device usage and withdrawal symptoms will be monitored for up to 5 days, or until you stop using the device early.",124,"You would wear the Sparrow Link device for up to 5 days. Your withdrawal symptoms will be assessed multiple times on the first day and then daily for up to 5 days.","Not stated in the trial record.",[],"v2"]