Sparrow Link Device for Opioid Withdrawal in Hospitalized Adults with OUD
Sparrow Link (Active tAN)
+ Sparrow Link (Sham tAN)
Narcotic-Related Disorders+6
+ Anxiety Disorders
+ Behavior
Treatment Study
Summary
Study start date: February 21, 2026
Actual date on which the first participant was enrolled.The study is exploring a new device called the Sparrow Link to help manage opioid withdrawal symptoms in adults who are hospitalized and dealing with opioid use disorder. Opioid withdrawal can make it challenging for patients to start or stick with treatment, sometimes causing them to leave the hospital early. The Sparrow Link device uses a technique called transcutaneous auricular neurostimulation (tAN) to stimulate certain nerves in the ear, which may reduce withdrawal symptoms when used alongside standard treatment. This research is significant because finding effective ways to manage withdrawal could improve treatment outcomes and make hospital stays more manageable for patients. Participants in this study are randomly assigned to one of two groups: one group receives active nerve stimulation using the Sparrow Link device, while the other group receives a non-active version of the treatment for comparison, ensuring no bias in results. All participants continue to receive usual care for opioid withdrawal, including medications like methadone or buprenorphine. The study focuses on how well the device is used and its impact on withdrawal symptoms, pain, anxiety, and other related factors. Researchers also gather information on the device's ease of use and potential integration into hospital care routines. The device is applied during the day and monitored by trained staff, with outcomes measured using clinical scales and feedback from both patients and healthcare providers.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Eligible participants must meet at least ONE of the following criteria: 1. Are continuing to experience opioid withdrawal symptoms: 1. Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications, or 2. During tapering or detox from full agonist opioids. OR 2. 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. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location