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.
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