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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 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04556552
The ClinicalTrials.gov registry entry for NCT04556552 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham Stimulation is the first listed.
NCT04556552 reports 0 study locations.
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.
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