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NCT04556552 · ClinicalTrials.gov registry record · Phase 3
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
A Phase 3 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT04556552: Completed Phase 3 study, sponsored by Emory University.
NCT04556552 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04556552, a Phase 3 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. Recruitment will be from treatment programs in the greater Atlanta Metropolitan Region including the DeKalb Community Service Board residential, detoxification and other treatment programs which with over 30,000 patient visits per year represents the largest treatment program in one of two urban counties in greater Atlanta. This trial involves a second phase after completing an exploratory study in 20 patients with OUDs to assess different timing parameters of nVNS effects on sympathetic measures and symptoms of craving, as well as modelling to verify and iteratively refine the methods for vagal nerve stimulation. The investigators in this trial will then apply nVNS comparing active (N=10) to sham (N=10) in OUD patients recently started on medication, looking at opioid craving, brain functional response with HR-PET, and cardiovascular and inflammatory biomarker responses to imagery-induced opioid drug craving.
Primary Outcome
Opioid craving will be measured based on Visual Analogue Scale (VAS) VAS consist in 10-point lines anchored with "not at all" on one end and "extremely" on the other where participants report the extent to which they felt any craving for opiates, severity of withdrawal symptoms, and the extent to which the study intervention has helped to ease the cravings. Total possible score ranges from 0 to100, with 100 correlating with worse study outcome.
Interventions
- DEVICE Sham Stimulation
- DEVICE Non invasive VN stimulation (nVNS)
- DRUG Oxygen (15-O) Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2022-09-13 |
| Phase | Phase 3 |
What the finished NCT04556552 record still lists
NCT04556552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Stimulation is the first listed.
NCT04556552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04556552 about?
NCT04556552 is a clinical study titled "Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders". Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. Recruitment will be from treatment programs in the greater Atlanta Metropolitan Region including the DeKalb Community Service Board residential, de...
What is the current status of trial NCT04556552?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2020-11-13. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT04556552?
The interventions under investigation include: Sham Stimulation (DEVICE), Non invasive VN stimulation (nVNS) (DEVICE), Oxygen (15-O) Water (DRUG).
Who is sponsoring clinical trial NCT04556552?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04556552's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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