Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399653
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-30
Brief Title:
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Alcohol use disorder AUD is a major health concern amongst Veterans as it causes functional impairments and decreased quality of life Current AUD treatments show limited effectiveness in reducing withdrawal-related psychological and physical distress which drives the urge to drink to relieve these symptoms The investigators propose the vagus nerve which is the primary nerve of the rest and digest branch of the autonomic nervous system via its bidirectional connections between the brain and the body as a novel treatment target for AUD The goal of this study is to assess treatment efficacy and mechanism of action Noninvasive neuromodulation technologies offer the possibility for innovative low risk treatments to support the rehabilitation and community reintegration of Veterans with AUD
Detailed Description:
Alcohol use disorder AUD is a serious mental health disorder that affects more than 40 of US military Veterans presenting a major burden to this population and to the VA Healthcare System Relapse rates of AUD are extremely high over half of Veterans who complete treatment relapse within 6 months highlighting the need for improved treatments or different treatment targets Long-term excessive drinking results in homeostatic dysregulation due to changes in the central and autonomic nervous system which manifests in psychological and physical distress during abstinence and results in the urge to drink to relieve these symptoms These symptoms which can be equated to withdrawal lead to continued harmful drinking and relapse and are associated with significant functional impairment and reduced quality of life
Current AUD treatments do not effectively mitigate this homeostatic dysregulation and have risks and side effects as well as other limitations The investigators propose the vagus nerve which is the main nerve of the parasympathetic branch of the autonomic nervous system and plays an important role in maintaining and restoring physiological homeostasis as a novel treatment target for AUD Noninvasive stimulation of the vagus nerve nVNS has been shown to alleviate anxiety depression and pain The investigators hypothesize that nVNS can restore homeostasis and reduce withdrawal-related distress and craving and consequently improve functional outcomes and quality of life in Veterans with AUD
The goal of this study is to assess treatment efficacy and mechanism of action The proposed study will include 80 Veterans with current AUD who will be randomized to receive nVNS or sham stimulation prior to performing a well-validated heat pain task designed to assess neural and physiological correlates of distress Subjects will then self-administer nVNSsham at home twice a day for 7 days and return for a follow-up visit during which all study components will be repeated Behavioral assessments of psychological and physiological distress craving and functional outcomes will be administered at baseline and post-treatment as well as at a 1-month follow-up visit
Current AUD treatments do not effectively mitigate this homeostatic dysregulation and have risks and side effects as well as other limitations The investigators propose the vagus nerve which is the main nerve of the parasympathetic branch of the autonomic nervous system and plays an important role in maintaining and restoring physiological homeostasis as a novel treatment target for AUD Noninvasive stimulation of the vagus nerve nVNS has been shown to alleviate anxiety depression and pain The investigators hypothesize that nVNS can restore homeostasis and reduce withdrawal-related distress and craving and consequently improve functional outcomes and quality of life in Veterans with AUD
The goal of this study is to assess treatment efficacy and mechanism of action The proposed study will include 80 Veterans with current AUD who will be randomized to receive nVNS or sham stimulation prior to performing a well-validated heat pain task designed to assess neural and physiological correlates of distress Subjects will then self-administer nVNSsham at home twice a day for 7 days and return for a follow-up visit during which all study components will be repeated Behavioral assessments of psychological and physiological distress craving and functional outcomes will be administered at baseline and post-treatment as well as at a 1-month follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None