Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Withdrawal Symptoms, Opioid Use Disorder, Opioid Use

In brief

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.

Key facts

Study ID

NCT05834478

Run by

Emory University

People needed

103

Starts

2024-02-20

Expected to finish

2027-04-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Emory University Clinical Research Network — Atlanta, Georgia, United States (enrolling)
• Rollins School of Public Health — Atlanta, Georgia, United States (enrolling)
• 12 Executive Park Drive — Atlanta, Georgia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Georgia Institute of Technology — Atlanta, Georgia, United States (enrolling)
• Health Sciences Research Building — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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