Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Description

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

Withdrawal Symptoms, Opioid Use Disorder, Opioid Use

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Study Overview

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Study Details

Study overview

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.

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Condition
Withdrawal Symptoms
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University Clinical Research Network, Atlanta, Georgia, United States, 30322

Atlanta

Health Sciences Research Building, Atlanta, Georgia, United States, 30322

Atlanta

Rollins School of Public Health, Atlanta, Georgia, United States, 30322

Atlanta

12 Executive Park Drive, Atlanta, Georgia, United States, 30329

Atlanta

Emory Univeristy, Atlanta, Georgia, United States, 30329

Atlanta

Georgia Institute of Technology, Atlanta, Georgia, United States, 30332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 lofexidine 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

James D Bremner, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-12