NCT05834478 Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
| NCT ID | NCT05834478 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Emory University |
| Condition | Withdrawal Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 103 participants in total. It began in 2024-02-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
James D Bremner, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05834478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Withdrawal Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05834478 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 103 participants.
Is NCT05834478 currently recruiting?
Yes, NCT05834478 is actively recruiting participants. Contact the research team at jdbremn@emory.edu for enrollment information.
Where is the NCT05834478 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States, Atlanta, United States and 2 additional locations.
Who is sponsoring the NCT05834478 clinical trial?
NCT05834478 is sponsored by Emory University. The principal investigator is James D Bremner, MD at Emory University. The trial plans to enroll 103 participants.