Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05834478

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Led by Emory University · Updated on 2026-03-27

103

Participants Needed

6

Research Sites

162 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.

CONDITIONS

Official Title

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet criteria for Opioid Use Disorders based on DSM5 criteria
  • Willing to undergo supervised withdrawal
  • Willing to transition to medication for opioid use disorder (MOUD) or behavioral management during treatment aftercare
Not Eligible

You will not qualify if you...

  • Positive pregnancy test or breastfeeding for women
  • History of meningitis
  • Traumatic brain injury
  • Current treatment with methadone, naltrexone, or Suboxone or medications contraindicated with hydromorphone or clonidine
  • History of head trauma with loss of consciousness over one minute not related to overdose
  • Moderate to severe non-opioid use disorders in the past year requiring separate withdrawal
  • Current or lifetime schizophrenia, schizoaffective disorder, or bulimia
  • Serious medical or neurological illness including liver disease or elevated liver enzymes (AST, ALT) over three times normal
  • Lack of venous access preventing PET imaging
  • Active implantable device like pacemaker or other VNS device
  • History of shrapnel or foreign bodies preventing MRI scanning
  • Positive COVID-19 test

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Emory University Clinical Research Network

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Health Sciences Research Building

Atlanta, Georgia, United States, 30322

Not Yet Recruiting

3

Rollins School of Public Health

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

12 Executive Park Drive

Atlanta, Georgia, United States, 30329

Actively Recruiting

5

Emory University

Atlanta, Georgia, United States, 30329

Actively Recruiting

6

Georgia Institute of Technology

Atlanta, Georgia, United States, 30332

Actively Recruiting

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Research Team

J

James D Bremner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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