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Sparrow Link Device for Opioid Withdrawal in Hospitalized Adults with OUD

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What is being tested

Sparrow Link (Active tAN)

+ Sparrow Link (Sham tAN)
Device
Who is being recruted

Opioid Withdrawal

+ Opioid Use Disorder (OUD)
Over 18 Years
+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorPayel Roy
Study ContactPayel J Roy, MD, MSc
Last updated: August 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 21, 2025Actual 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.

Official TitleSparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service) 
Principal SponsorPayel Roy
Study ContactPayel J Roy, MD, MSc
Last updated: August 8, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Opioid Withdrawal
Opioid Use Disorder (OUD)
Criteria
10 inclusion criteria required to participate
ligible 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

Show More Criteria

11 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Active tAN stimulation in addition to standard of care for opioid withdrawal management
Group II
Sham
Sham tAN stimulation in addition to standard of care for opioid withdrawal management
Study Objectives
Primary Objectives

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.

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.

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.
Secondary Objectives

Proportion of randomized participants who decline to initiate device use after allocation.

Proportion of participants reporting discomfort or physical side effects while wearing the device, regardless of discontinuation.

Proportion of participants in the active arm who experience one or more technical issues (e.g., stimulation interruption, electrode detachment, app malfunction).

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.)

Proportion of participants who express intent to attend follow-up treatment post-discharge.

Composite outcome defined as presence of either: (a) documented referral or (b) participant-reported intent to engage in care.

Proportion of active-arm participants expressing desire to use the device again in the future for opioid withdrawal management.

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
Suspended
UPMC PresbyterianPittsburgh, United StatesSee the location
Recruiting soonOne Study Center