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

Conditions

• Alcohol Use Disorder

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cervical transcutaneous vagus nerve stimulation (active comparator) — DEVICE
  Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.
• Cervical transcutaneous vagus nerve stimulation (sham comparator) — DEVICE
  Sham nVNS devices look identical to active devices and participants will undergo identical training for self-administration on upper anterior cervical area (overlying carotid artery). Sham devices do not stimulate the vagus nerve.

Study Details

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.

Key Dates

Start date

Jan 1, 2025

Status verified

Mar 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active cervical transcutaneous vagus nerve stimulation
  Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.
• Placebo Comparator: Sham cervical transcutaneous vagus nerve stimulation
  Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.

Primary Outcome Measure

Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline to week 1 and 1 month post baseline of 2x daily intervention ]

Central Contacts

• Ruth Klaming, PhD
  (858) 642-3538
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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