Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Recruiting Phase 3 Interventional Study
Withdrawal Symptoms Opioid Use Disorder Opioid Use
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
103 (estimated)
Sponsor
Emory University · Other
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About This Trial
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 co…
Trial Locations
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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 menin…
Contacts

James D Bremner, MD

404-712-9569

jdbremn@emory.edu

CONTACT