Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04556552
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2020-09-15
Brief Title:
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
nVNS in OUDs
Brief 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 30000 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 N10 to sham N10 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
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 N10 to sham N10 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
Detailed Description:
Subjects in this study will be patients with opioid use disorders OUDs based on DSM-5 criteria recruited from the greater Atlanta metropolitan region The metropolitan Atlanta area has about 2623744 persons age 12 or older According to the Substance Abuse and Mental Health Services Administration SAMHSA 109777 418 have non-medical use of prescription pain relievers and 48302 are estimated to have an opioid use disorder This DSMP describes the UG3 phase which will study patients with OUDs early in the course of treatment The Go-No Go criteria listed below have to be met to proceed to the UH3 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 30000 patient visits per year represents the largest treatment program in one of two urban counties in greater Atlanta
The first UG3 phase will involve 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 our methods for vagal nerve stimulation The investigators in this trial will then apply nVNS in a pilot study comparing active N10 to sham N10 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 Brain function will be measured with high resolution positron emission tomography HR-PET autonomic function with wearable sensing devices and biomarkers will be measured in blood with an assessment of a broad range of stress responsive sympathetic hormonal and immune markers
The first UG3 phase will involve 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 our methods for vagal nerve stimulation The investigators in this trial will then apply nVNS in a pilot study comparing active N10 to sham N10 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 Brain function will be measured with high resolution positron emission tomography HR-PET autonomic function with wearable sensing devices and biomarkers will be measured in blood with an assessment of a broad range of stress responsive sympathetic hormonal and immune markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG3DA048502 | NIH | None | httpsreporternihgovquickSearchUG3DA048502 |