Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Fallypride

Criteria

Inclusion Criteria:

• Meet criteria for OUDs based on the Mini International Neuropsychiatric Interview (MINI)

• 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 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, based on the MINI

• 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)

• Carotid atherosclerosis

• Cervical vagotomy

• History of shrapnel or other foreign bodies which would preclude MRI scanning