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Ear-Zapping device aims to keep opioid users on track

NCT ID NCT06130501

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times

Summary

This study tests a small ear device that gently stimulates nerves to see if it helps people with both PTSD and opioid use disorder stay on buprenorphine therapy. Twenty participants will use either the active device or a placebo for 12 weeks. Researchers will check if they keep their buprenorphine prescription and how well they tolerate the device.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sparrow Ascent device (transcutaneous auricular neurostimulation)
What this could lead to
If it works, this could offer a drug-free way to help people with PTSD and opioid use disorder stick with buprenorphine therapy, improving recovery chances.
What could go wrong
This is a very small early study with only 20 people, so results may not apply widely. The device may be no better than a placebo, and some may find it uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jul 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18-65. * Patient seeking buprenorphine therapy (BUP) for opioid use disorder and able to be randomized within 28 calendar days of induction on BUP. * Meets Diagnostic and Statistical Manual - 5 (DSM-5) diagnostic criteria for moderate to severe opioid use disorder with induction on buprenorphine. This includes volunteers who have taken buprenorphine in the past and are re-starting, are currently receiving non-buprenorphine medication for opioid use disorder, or have taken non-buprenorphine medication for opioid use disorder in the past and are transitioning to buprenorphine therapy for the first time. * Meets DSM-5 diagnostic criteria for posttraumatic stress disorder (PTSD). * Is able to understand the study, and having understood, provide written informed consent in English. * Provides permission to extract data from the participant's electronic medical record. Exclusion Criteria: * Unable to provide sufficient contact information (must provide at least two reliable indicators). * Volunteers who will not undergo induction on BUP within the eligibility window for randomization. * Volunteers who intend to, or will receive, inpatient substance use disorder (SUD) care at the time of randomization. Volunteers receiving inpatient detoxification care at the time of screening or baseline assessment are eligible if they will no longer be receiving inpatient care when they would be randomized for the study. * Volunteers actively participating in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, etc.). * Volunteers who will not have been stable on medications that affect PTSD (i.e., sertraline, paroxetine, venlafaxine, prazosin, or trazodone) for at least four weeks before they could be randomized. * Volunteer presents current evidence of an uncontrolled and/or clinically significant medical or psychiatric condition that will impact their ability to comply with the study requirements or would make their study participation unsafe. This includes unmedicated bipolar disorder with a manic episode in the past month or unmedicated psychotic disorder. * Volunteer has a history of epileptic seizure. * Volunteer has a history of neurological disorder or traumatic brain injury with significant lasting effects (e.g., memory problems, emotional changes, behavioral changes). * Volunteer had a suicide attempt leading to hospital admission in the past month or suicidal ideation with a plan and intent to act upon it in the past month. * Volunteer has the presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators). * Volunteer has abnormal ear anatomy or an ear infection is present. * Volunteer is pregnant or lactating. * Volunteers of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study's active participation period (i.e., 12 weeks following randomization). * Volunteer has any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the project's trial. These include circumstances such as impending incarceration, moving out of the area, or a general history of noncompliance.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Gibson Center for Behavioral Change

    Cape Girardeau, Missouri, 63703, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.