Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Launched by EMORY UNIVERSITY · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how a treatment called Vagal Nerve Stimulation (VNS) can help people experiencing withdrawal symptoms from opioids. The study aims to see how different doses of VNS affect individuals with Opioid Use Disorder (OUD) during a one-week stay in a hospital for research. Participants will go through some tests, including brain scans and questionnaires, to monitor their responses and gather important data. After their stay, there will be a follow-up call 1 to 3 months later to check on their progress.

To be eligible for the study, participants must meet specific criteria, such as having a diagnosed Opioid Use Disorder and being willing to undergo supervised withdrawal. The trial is open to adults ages 18 and older, but there are some exclusions, such as individuals who are pregnant, have certain serious medical conditions, or are currently using specific medications. Overall, this study seeks to explore a promising treatment option for those struggling with opioid withdrawal, providing valuable insights into their recovery journey.

Gender

ALL

Eligibility criteria

• 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