Opioid Withdrawal study: Sparrow Link
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 checks if a wearable device that sends gentle electrical signals to the ear is easy to use and if it helps reduce withdrawal symptoms.
- Who it's for
- The study is looking for adults who are currently in the hospital being treated for opioid use disorder.
- What's involved
- Participants will wear a small device on their ear for a set time. They will also answer questions about their pain, mood, and cravings while receiving standard hospital care.
- Time commitment
- The study lasts for the duration of the hospital stay, with no extra visits required.
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
- Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications, or
- During tapering or detox from full agonist opioids. OR
- 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.
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
- Despite Maximal medical therapy with methadone, buprenorphine, full agonist opioids, or non-opioid medications, or
- During tapering or detox from full agonist opioids. OR
- 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 is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.