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New treatment option for Opioid Withdrawal
Official title Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder
ClinicalTrials.gov ID: NCT07079826
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Have chosen to decline methadone or buprenorphine but still require support for withdrawal symptoms and/or pain management. Additionally...
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.