Sparrow Link Device for Opioid Withdrawal Syndrome

Overseen By Payel J Roy, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Payel Roy

Must be taking: Methadone, Buprenorphine

Disqualifiers: Seizure disorder, Cardiac device, Neurostimulator, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device called the Sparrow Link to determine its effectiveness in reducing withdrawal symptoms in individuals treated for opioid use disorder (OUD). The device sends small electrical signals to nerves in the outer ear. Researchers aim to assess its ease of use, comfort, and impact on symptoms such as pain, cravings, and mood. Participants will use either the active device or a sham (inactive) version while continuing their regular hospital care. The study seeks adults with an active history of OUD who experience withdrawal symptoms despite treatment or who have chosen not to use medications like methadone or buprenorphine. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options for OUD.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. Participants will continue receiving standard hospital care for opioid withdrawal, which may include medications you are already taking.

What prior data suggests that the Sparrow Link device is safe for opioid withdrawal syndrome?

Research has shown that the Sparrow Link device, which employs transcutaneous auricular neurostimulation (tAN), is safe for people. In one study, tAN provided a non-drug method to ease opioid withdrawal symptoms. This effectiveness contributed to the device receiving FDA approval, indicating its likely safety. Previous research found that participants experienced mild or no withdrawal symptoms after just 60 minutes of therapy. These results suggest that tAN is well-tolerated, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sparrow Link device because it offers a novel approach to managing opioid withdrawal syndrome. Unlike traditional treatments that often rely on medications like methadone or buprenorphine, this device uses transcutaneous auricular neurostimulation (tAN) to potentially ease withdrawal symptoms. By stimulating nerves in the ear, Sparrow Link could provide a non-pharmacological alternative, reducing the risk of dependency associated with medication-based therapies. This new method might offer quicker relief from withdrawal symptoms, which could be a game-changer for individuals seeking to overcome opioid addiction.

What evidence suggests that the Sparrow Link device is effective for opioid withdrawal?

Research shows that transcutaneous auricular neurostimulation (tAN), as used in the Sparrow Link device, is a promising non-drug method to reduce symptoms of opioid withdrawal syndrome (OWS). Studies have found that tAN can safely manage withdrawal symptoms by sending gentle electrical signals to nerves in the outer ear. This method has proven effective enough to receive FDA clearance for similar devices. In this trial, participants will receive either active tAN stimulation with the Sparrow Link device or a sham tAN stimulation, both alongside standard care for opioid withdrawal management. The Sparrow Link aims to balance the body's nervous system, potentially easing the difficult effects of withdrawal. These findings suggest that the device could be a useful tool in reducing opioid withdrawal symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Payel J Roy, MD, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for hospitalized adults with opioid use disorder (OUD) who are experiencing withdrawal. It's designed to see if a wearable device can help manage their symptoms alongside standard care. Participants must be undergoing treatment for OUD, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Be able to provide informed consent

Have a COWS score between 5-24 (Mild-moderate opioid withdrawal), indicating residual withdrawal symptoms

I am 18 years old or older.

Exclusion Criteria

Presence of a cardiac device (e.g., pacemaker, defibrillator)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either active or sham tAN stimulation in addition to standard care for opioid withdrawal management

5 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including referral to follow-up care

Up to 5 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Sparrow Link

Trial Overview The Sparrow Link device, which uses transcutaneous auricular neurostimulation (tAN), is being tested. This non-invasive technique involves sending electrical signals to nerves in the ear to potentially ease opioid withdrawal symptoms. Patients will either get an active device or a sham version without knowing which one they have.

How Is the Trial Designed?

Group I: Active tAN + Standard Care Active Control 1 Intervention

Active tAN stimulation in addition to standard of care for opioid withdrawal management

Group II: Sham tAN + Standard Care Placebo Group 1 Intervention

Sham tAN stimulation in addition to standard of care for opioid withdrawal management

Who Is Running the Clinical Trial?

Payel Roy

Lead Sponsor

UPMC Ladies Hospital Aid Society

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07079826

Sparrow Link Neuromodulation Device for Opioid ... The primary effectiveness outcome is change in opioid withdrawal severity, as measured by the Clinical Opiate Withdrawal Scale (COWS). The study also includes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385243/

Delivering transcutaneous auricular neurostimulation (tAN) to ... Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.

3. sparkbiomedical.com sparkbiomedical.com/veterans-administration

Effective Opioid Withdrawal Solution for Veterans Sparrow Ascent utilizes Transcutaneous Auricular Neurostimulation (tAN®) to balance the autonomic nervous system and manage the effects of withdrawal symptoms.

4. ctv.veeva.com ctv.veeva.com/study/sparrow-link-neuromodulation-device-for-opioid-withdrawal-management-in-hospitalized-adults-with-opi

Sparrow Link Neuromodulation Device for Opioid Withdrawal ... This study is evaluating the Sparrow Link, a wearable device that delivers gentle electrical signals to nerves in the outer ear (a technique ...

5. patlynk.com patlynk.com/trial/NCT07079826

Sparrow Link Device for Opioid Withdrawal in Hospitalized ... 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 ...

6. sparkbiomedical.com sparkbiomedical.com/healthcare-providers/neurological-health

A Better Way Forward in Opioid Withdrawal Management Clinical Results at a Glance · 0%. of participants experienced mild or no withdrawal symptoms after 60 minutes of therapy. · 0%. of participants sustained a ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230796.pdf

June 20, 2023 Spark Biomedical, Inc. Allison Komiyama, PhD ... The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in ...