Non-invasive treatment for opioid withdrawal using vagal nerve stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of non-invasive Vagal Nerve Stimulation (VNS) on withdrawal symptoms in individuals with Opioid Use Disorders (OUDs). Participants will undergo a one-week inpatient stay where they will receive VNS treatment, complete psychiatric assessments, and undergo brain imaging. The study aims to determine how VNS can alleviate withdrawal symptoms and cravings associated with opioid cessation. Follow-up assessments will occur 1-3 months post-treatment to evaluate long-term effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University Clinical Research Network
  Atlanta, Georgia, United States Recruiting
• Rollins School of Public Health
  Atlanta, Georgia, United States Recruiting
• 12 Executive Park Drive
  Atlanta, Georgia, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Georgia Institute of Technology
  Atlanta, Georgia, United States Recruiting
• Health Sciences Research Building
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: James D Bremner, MD — Emory University
• Study coordinator: James D Bremner, MD
• Email: jdbremn@emory.edu
• Phone: 404-712-9569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.