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Vagal Nerve Stimulation for Opioid Use Disorder (VNS in OUD UH3 Trial)
VNS in OUD UH3 Trial Summary
This trial is researching how VNS affects opioid addiction. Participants will stay in a research hospital for 1 wk, have MRI scans, and be monitored 1-3 mo after. Questionnaires, interviews, brain imaging, and VNS testing are part of the process.
VNS in OUD UH3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VNS in OUD UH3 Trial Design
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Who is running the clinical trial?
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- I am not on methadone, naltrexone, Suboxone, or drugs that clash with hydromorphone or lofexidine.I do not have any serious illness that would stop me from joining the study.I have had meningitis before.I have had a traumatic brain injury.I am willing to stop my current treatment under supervision.
- Group 1: Transcutaneous Cervical Vagal Nerve Stimulation Device
- Group 2: Sham Stimulation Device
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the eligibility for this trial extend beyond octogenarians?
"This research trial is seeking participants of legal age - that is, 18 or over but younger than 75 years old."
What criteria must be met to qualify for participation in this clinical trial?
"To be eligible for this research study, applicants must have withdrawn from their current course of treatment and fall between the age range of 18 to 75. At present, approximately 103 individuals are being accepted into the clinical trial."
What sort of perils are associated with the Transcutaneous Cervical Vagal Nerve Stimulation Device?
"Due to the efficacy and safety data collected in Phase 3 trials, our group at Power believes that Transcutaneous Cervical Vagal Nerve Stimulation Device warrants a score of three on a scale from one to three."
Are applications still being accepted to join this research program?
"According to clinicaltrials.gov, this particular medical trial is not currently admitting patients; it was initially posted on June 1st 2023 and last edited April 14th 2023. Despite that, 678 other clinical trials are presently recruiting participants for their study protocols."
What are the anticipated results from this clinical experiment?
"The primary objective of this medical trial, to be assessed across Day 2 and 3, is evaluating the safety profile of transcutaneous vagus nerve stimulation (tcVNS). Secondary goals include assessing adherence to Medication for Opioid Use Disorders (MOUD), changes in brain dopamine D1 & D2/3 receptor regional binding potentials as measured by [F-18]fallypride with high-resolution positron emission tomography (HR-PET) scans during rest on day 2 and when actively using tcVNS or sham while watching videos. Lastly, heart rate will also be monitored continuously through ambulatory monitors"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Emory University Clinical Research Network: < 48 hours
Average response time
- < 2 Days
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