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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: Recruiting Phase 3 study of Opioid Use Disorder and Opioid Use, sponsored by Emory University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All participants will complete the Subjective Opiate Withdrawal Scale (SOWS). The total score on each day will be compared between active tcVNS versus sham stimulation. The SOWS is performed four times daily. The total SOWS score is the sum of the individual item scores and ranges from 0 to 64, with a higher score indicating greater withdrawal severity.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT05834478 shows while recruiting
NCT05834478 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower).
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 lists 6 locations in 1 state (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.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05834478's enrollment target sits among peer trials
103 129th of 257 higher than 129 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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