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Could a neck device curb opioid withdrawal?

NCT ID NCT05834478

Symptom relief Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a non-invasive device that stimulates the vagus nerve in the neck can reduce withdrawal symptoms in people with opioid use disorder. About 103 participants will stay in the hospital for a week, receive either active or sham stimulation, and have brain scans. The goal is to see if the device makes withdrawal less severe and helps people stick with treatment.

What this could mean

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

Active substance
transcutaneous cervical vagal nerve stimulation (tcVNS) device
What this could lead to
If it works, this could offer a drug-free way to reduce opioid withdrawal symptoms and help people stay in treatment.
What could go wrong
This is still a small, early-phase trial with only 103 participants, and the device may not work better than a sham. The study also requires an inpatient stay and MRI, which may limit who can take part.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

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 75 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: * Meet criteria for OUDs based on the DSM5 criteria * Willing to undergo supervised withdrawal * Willing to be transitioned to a MOUD or behavioral management during treatment aftercare Exclusion Criteria: * Positive pregnancy test or breastfeeding for women * History of meningitis * Traumatic brain injury * Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration * History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to overdose in the judgment of the study physician * Past year moderate to severe non-opioid use disorders that would require separate withdrawal management * Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia * History of serious medical or neurological illness or organic mental disorder, including liver disease, but also including cardiovascular, gastrointestinal, hepatic, renal, neurologic, or other systemic illness, including liver enzymes aspartate transaminase (AST) and alanine transaminase (ALT) more than three times upper limit of normal, that would preclude involvement based on the clinical judgment of the study psychiatrist * Lack of venous access that would preclude PET imaging * Active implantable device (i.e. pacemaker) or other VNS device exclusion * History of shrapnel or other foreign bodies that would preclude MRI scanning * Positive test for COVID-19

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Conditions

The condition(s) this trial relates to.

opiate dependence opioid abuse substance withdrawal syndrome

As listed by the trial registrant

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

Opioid use Opioid use disorder Withdrawal symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 12 Executive Park Drive

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Emory University Clinical Research Network

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Georgia Institute of Technology

    RECRUITING

    Atlanta, Georgia, 30332, United States

  • Health Sciences Research Building

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Rollins School of Public Health

    RECRUITING

    Atlanta, Georgia, 30322, United States

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