Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Device Usage Consistency (Percentage of Expected Wear Time Achieved)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •During tapering or detox from full agonist opioids.
- •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.
排除标准
- •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.
研究组 & 干预措施
Active tAN + Standard Care
Active tAN stimulation in addition to standard of care for opioid withdrawal management
干预措施: Sparrow Link (Active tAN) (Device)
Sham tAN + Standard Care
Sham tAN stimulation in addition to standard of care for opioid withdrawal management
干预措施: Sparrow Link (Sham tAN) (Device)
结局指标
主要结局
Device Usage Consistency (Percentage of Expected Wear Time Achieved)
时间窗: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
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.
Early Device Discontinuation (Percentage of Participants)
时间窗: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
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.
Clinical Opiate Withdrawal Scale (COWS)
时间窗: 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)
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.
次要结局
- Early Device Refusal Rate (Percentage)(Day 1)
- Device Discomfort Reported (Percentage)(From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).)
- Technical Issue Rate (Percentage)(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)(Through study completion, an average of 5 days)
- Intent to Engage in Care Rate (Percentage)(Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).)
- Post-Discharge Engagement Composite (Percentage)(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(Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).)
研究者
Payel Roy
Associate Professor
University of Pittsburgh