Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder (NCT07079826)
Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (12 items).
Location: UPMC Presbyterian — Pittsburgh, Pennsylvania
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UPMC Presbyterian — Pittsburgh, Pennsylvania
📞 Contact the Study Coordinator
Phone: (412) 692-4473
Email: payel.roy@pitt.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: All participants will receive standard hospital-based opioid withdrawal management, including pharmacologic treatment as clinically indicated (e.g., methadone, buprenorphine, or full opioid agonists).
More studies in Opioid Withdrawal
- Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder — Center City, Minnesota
- ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain — Charleston, South Carolina
- Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain — Galveston, Texas
- Assessing a Clinically-meaningful Opioid Withdrawal Phenotype — Baltimore, Maryland
Explore by condition: All Opioid Withdrawal clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.