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NCT05834478 · ClinicalTrials.gov registry record · Phase 3

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

A Phase 3 study of Opioid Use Disorder and Opioid Use, sponsored by Emory University.

Recruiting
Registry status
Phase 3
Development phase
103
Enrollment target
6
Study locations

NCT05834478 is a Phase 3 study of Opioid Use Disorder and Opioid Use that is actively recruiting participants, run by Emory University. The registered enrollment target is 103 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 1 state.

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The verdict

NCT05834478, a Phase 3 study of Opioid Use Disorder and Opioid Use, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 3
Development phase
103 participants
Enrollment target
6
Study locations

Study 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.

Conditions Studied

Opioid Use Disorder Opioid Use Withdrawal Symptoms

Interventions

  • DEVICE Sham Stimulation
  • DEVICE Transcutaneous Cervical Vagal Nerve Stimulation
  • DRUG [F-18]Fallypride

Study Locations (6)

Georgia

  • Emory University Clinical Research Network - Atlanta
  • Health Sciences Research Building - Atlanta
  • Rollins School of Public Health - Atlanta
  • 12 Executive Park Drive - Atlanta
  • Emory Univeristy - Atlanta
  • Georgia Institute of Technology - Atlanta

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2024-02-20
Est. Completion 2026-12
Phase Phase 3

Sponsor

Emory University

1,208 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05834478

The ClinicalTrials.gov registry entry for NCT05834478 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Sham Stimulation is the first listed.

NCT05834478 reports 6 study locations spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05834478 about?

NCT05834478 is a clinical study titled "Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3". 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, hav...

What is the current status of trial NCT05834478?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2024-02-20. Estimated completion is 2026-12.

What conditions does trial NCT05834478 study?

This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Use, Withdrawal Symptoms.

What interventions are being tested in trial NCT05834478?

The interventions under investigation include: Sham Stimulation (DEVICE), Transcutaneous Cervical Vagal Nerve Stimulation (DEVICE), [F-18]Fallypride (DRUG).

Who is sponsoring clinical trial NCT05834478?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05834478 being conducted?

This trial has 6 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.