Non-invasive treatment for opioid withdrawal using vagal nerve stimulation
Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
This study is testing whether a non-invasive treatment using Vagal Nerve Stimulation can help people with opioid use disorders feel better during withdrawal and reduce cravings.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 6 sites (Atlanta, Georgia and 5 other locations) |
| Trial ID | NCT05834478 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Opioid Use Disorders who are willing to undergo supervised withdrawal.
Not a fit: Patients currently receiving methadone, naltrexone, or Suboxone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for individuals struggling with opioid withdrawal and cravings.
How similar studies have performed: Previous studies have shown that Vagal Nerve Stimulation can be effective for conditions like epilepsy and depression, suggesting potential for success in treating opioid withdrawal.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 5 other locations
- Emory University Clinical Research Network — Atlanta, Georgia, United States (Recruiting)
- Health Sciences Research Building — Atlanta, Georgia, United States (Not_yet_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)
Study contacts
- Principal investigator: James D Bremner, MD — Emory University
- Study coordinator: James D Bremner, MD
- Email: jdbremn@emory.edu
- Phone: 404-712-9569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.