Opioid WithdrawalNCT07079826
Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder
A study testing Sparrow Link (Active tAN) in people with Opioid Withdrawal and Opioid Use Disorder (OUD), run by Payel Roy at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Withdrawal, Opioid Use Disorder (OUD)
- What is being tested?
- Sparrow Link (Active tAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- or
- During tapering or detox from full agonist opioids.
- OR
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Payel J Roy, MD, MSc, 4126924473, payel.roy@pitt.edu
Gagandeep S Shergill, MS, 4125778978, gas246@pitt.edu
About this study
Official title: Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)
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.
Read the detailed description
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.
- Conditions
- Opioid Withdrawal, Opioid Use Disorder (OUD)
- Being tested
- Sparrow Link (Active tAN), Sparrow Link (Sham tAN)
- Keywords
- transcutaneous auricular neurostimulation, Sparrow Link, tAN, vagus nerve stimulation, trigeminal nerve stimulation, neuromodulation, Clinical Opiate Withdrawal Scale, opioid craving, inpatient addiction care, withdrawal management, Addiction Medicine, anxiety, depression
- Medical subject headings
- Opioid-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow Link (Active tAN)Device
Participants will receive the Sparrow Link device with active transcutaneous auricular neurostimulation (tAN) in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated.
Sparrow Link (Sham tAN)Device
Participants will receive the Sparrow Link device with sham (non-active) stimulation in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN + Standard Care | Active comparator | Active tAN stimulation in addition to standard of care for opioid withdrawal management Receives: Device: Sparrow Link (Active tAN) |
| Sham tAN + Standard Care | Sham comparator | Sham tAN stimulation in addition to standard of care for opioid withdrawal management Receives: Device: Sparrow Link (Sham tAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Usage Consistency (Percentage of Expected Wear Time Achieved)
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.
Measured: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Early Device Discontinuation (Percentage of Participants)
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.
Measured: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Clinical Opiate Withdrawal Scale (COWS)
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.
Measured: 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)
Secondary outcomes (7)
Early Device Refusal Rate (Percentage)
Proportion of randomized participants who decline to initiate device use after allocation.
Measured: Day 1
Device Discomfort Reported (Percentage)
Proportion of participants reporting discomfort or physical side effects while wearing the device, regardless of discontinuation.
Measured: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Technical Issue Rate (Percentage)
Proportion of participants in the active arm who experience one or more technical issues (e.g., stimulation interruption, electrode detachment, app malfunction).
Measured: 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)
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.)
Measured: Through study completion, an average of 5 days
Intent to Engage in Care Rate (Percentage)
Proportion of participants who express intent to attend follow-up treatment post-discharge.
Measured: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Post-Discharge Engagement Composite (Percentage)
Composite outcome defined as presence of either: (a) documented referral or (b) participant-reported intent to engage in care.
Measured: 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
Proportion of active-arm participants expressing desire to use the device again in the future for opioid withdrawal management.
Measured: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start27 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Payel Roy
- Sponsor type
- University, hospital or other
- Collaborators
- UPMC Ladies Hospital Aid Society
- Responsible party
- Sponsor-investigator, Payel Roy, University of Pittsburgh
- Investigators
- Payel J Roy, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079826
- Sponsor's protocol ID
- STUDY24050080
- Status last verified
- May 2026
- First submitted
- 20 Jun 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data (IPD) from this early-phase feasibility study will not be shared due to participant confidentiality concerns, consent limitations, and the exploratory nature of the trial. Given the small sample size and potential re-identifiability of participants, especially within a high-risk inpatient population, sharing IPD could pose privacy risks. Additionally, the consent form does not explicitly authorize future data sharing, and the study's non-powered design limits generalizability of individual-level findings.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sparrow Link Device for Opioid Withdrawal Management at UPMC Presbyterian With the Substance Treatment and Recovery Service (STARS; Formerly Addiction Medicine Consult Service)
- ClinicalTrials.gov ID
- NCT07079826
- Acronym / sponsor ID
- STUDY24050080
- Conditions
- Opioid Withdrawal, Opioid Use Disorder (OUD)
- Keywords
- transcutaneous auricular neurostimulation, Sparrow Link, tAN, vagus nerve stimulation, trigeminal nerve stimulation, neuromodulation, Clinical Opiate Withdrawal Scale, opioid craving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Payel RoyUniversity, hospital or other
- Collaborators
- UPMC Ladies Hospital Aid Society
- Study start
- 27 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tAN + Standard Care | Active comparator | Device: Sparrow Link (Active tAN)Active tAN stimulation in addition to standard of care for opioid withdrawal management |
| Sham tAN + Standard Care | Sham comparator | Device: Sparrow Link (Sham tAN)Sham tAN stimulation in addition to standard of care for opioid withdrawal management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Are continuing to experience opioid withdrawal symptoms:
- or
- OR
- Have chosen to decline methadone or buprenorphine but still require support for withdrawal symptoms and/or pain management.
- Be 18 years old or older.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow Link (Active tAN)Participants will receive the Sparrow Link device with active transcutaneous auricular neurostimulation (tAN) in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated. | Device | Active tAN + Standard Care |
| Sparrow Link (Sham tAN)Participants will receive the Sparrow Link device with sham (non-active) stimulation in addition to standard hospital-based opioid withdrawal management. Standard care may include pharmacologic treatments such as methadone, buprenorphine, full agonist opioids (e.g., oxycodone), and non-opioid medications, as clinically indicated. | Device | Sham tAN + Standard Care |
Primary outcome
Device Usage Consistency (Percentage of Expected Wear Time Achieved)
Time frame: 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)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Early Device Refusal Rate (Percentage)
Time frame: Day 1
Device Discomfort Reported (Percentage)
Time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).
Technical Issue Rate (Percentage)
Time frame: 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)
Time frame: Through study completion, an average of 5 days
Intent to Engage in Care Rate (Percentage)
Time frame: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Post-Discharge Engagement Composite (Percentage)
Time frame: 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
Time frame: Assessed once at the final study exit interview (interview may occur for up to 5 days post-discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Study device linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) from this early-phase feasibility study will not be shared due to participant confidentiality concerns, consent limitations, and the exploratory nature of the trial. Given the small sample size and potential re-identifiability of participants, especially within a high-risk inpatient population, sharing IPD could pose privacy risks. Additionally, the consent form does not explicitly authorize future data sharing, and the study's non-powered design limits generalizability of individual-level findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Payel J Roy, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Link (Active tAN) in people with Opioid Withdrawal and Opioid Use Disorder (OUD), run by Payel Roy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Payel J Roy, MD, MSc (412-692-4473, payel.roy@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Usage Consistency (Percentage of Expected Wear Time Achieved) (time frame: From Day 1 through the final day of device wear or early device discontinuation (up to 5 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.