RECRUITING

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder

Conditions

Alcohol Use Disorder neuromodulation neuroimaging withdrawal anxiety autonomic nervous system

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder

Quick Facts

Study Start:2025-01-01

Study Completion:2029-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06399653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Veterans between 21 and 65 years, any race or ethnicity. 2. Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (\>5 drinks (men) / \>4 drinks (women) on the same occasion, on 5 or more days in the past month) as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA), and mild to moderate withdrawal symptoms during abstinence. 3. Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications. 4. Capable of complying with study schedule, procedures, and speaks English. 5. Able to provide voluntary written informed consent prior to initiation of visit 1. 6. Able and willing to self-administer nVNS/sham stimulation as instructed for the duration of the study, and willing to commit to the return visit at the end of the study.	1. Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 on the day of the scan (symptoms judged to be due to co-existing anxiety or headache disorders will not be counted toward the total). 2. Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens). 3. Currently or recently (within last 90 days) enrolled in abstinence-based treatment program. 4. Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit. 5. Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD. 6. At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview). 7. History of neurological disorder that might be associated with cognitive dysfunction. 8. History of head trauma involving loss of consciousness \>24 hours 9. Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit. 10. MRI-related

Inclusion Criteria

Exclusion Criteria

1. Veterans between 21 and 65 years, any race or ethnicity.
2. Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (\>5 drinks (men) / \>4 drinks (women) on the same occasion, on 5 or more days in the past month) as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA), and mild to moderate withdrawal symptoms during abstinence.
3. Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications.
4. Capable of complying with study schedule, procedures, and speaks English.
5. Able to provide voluntary written informed consent prior to initiation of visit 1.
6. Able and willing to self-administer nVNS/sham stimulation as instructed for the duration of the study, and willing to commit to the return visit at the end of the study.

1. Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 on the day of the scan (symptoms judged to be due to co-existing anxiety or headache disorders will not be counted toward the total).
2. Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens).
3. Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
4. Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
5. Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD.
6. At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview).
7. History of neurological disorder that might be associated with cognitive dysfunction.
8. History of head trauma involving loss of consciousness \>24 hours
9. Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
10. MRI-related

Contacts and Locations

Study Contact

Ruth Klaming, PhD

CONTACT

(858) 642-3538

Ruth.Miller@va.gov

Principal Investigator

Ruth Klaming, PhD

PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Ruth Klaming, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01

Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

alcohol use disorder
neuromodulation
neuroimaging
withdrawal
anxiety
autonomic nervous system

Additional Relevant MeSH Terms

Alcohol Use Disorder