Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

NCT07814755 | Not Yet Recruiting FDA Device

• 1 other identifier: 303501
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate whether home-based auricular vagal neuromodulation therapy (AVNT) is practical, acceptable, and well tolerated for adults receiving treatment for substance use disorder. Participants will use a handheld device that delivers mild electrical stimulation to the ear for approximately 60 minutes each day over 30 days. Researchers will examine whether participants can successfully use the device as directed and complete study procedures. The study will also explore whether use of the device is associated with changes in depression, anxiety, sleep problems, and substance craving.

Conditions

Substance Use Disorder (SUD)

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Number of participants enrolled divided by the number of participants screened for eligibility.

  From enrollment to the end of treatment at 30 days

• Retention Rate

  Percentage of enrolled participants who remain active in the study through the Day 30 follow-up assessment.

  From enrollment to the end of treatment at 30 days

• Study Completion Rate

  Percentage of enrolled participants who complete all required end-of-study assessments at Day 30.

  From enrollment to the end of treatment at 30 days

• Adherence to AVNT Device Use

  Percentage of prescribed AVNT sessions completed during the 30-day study period, based on participant-reported device use and/or device usage records.

  From enrollment to the end of treatment at 30 days

• Participant-Reported Tolerability of AVNT Using the AVNT Tolerability Assessment

  Tolerability will be assessed using the study-specific AVNT Tolerability Assessment. Participants rate the severity of device-related symptoms (ear discomfort/pain, skin irritation, unpleasant stimulation sensations, headache, dizziness/lightheadedness, fatigue, nausea, and other symptoms) as None, Mild, Moderate, or Severe. The assessment also records whether device use resulted in reduced stimulation intensity, paused sessions, early session termination, skipped sessions, contact with the study team, or seeking medical care. Participants additionally provide an overall tolerability rating on a 5-point scale ranging from "Very easy to tolerate" to "Very difficult to tolerate.

  From enrollment to the end of treatment at 30 days

• Device Return Rate

  Percentage of participants who return study-issued AVNT devices at the end-of-study visit or upon withdrawal from the study.

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (7)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  From enrollment to the end of the study period at 30 days

• Change in Generalized Anxiety Disorder-7 (GAD-7) Score

  From enrollment to the end of the study period at 30 days

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  From enrollment to the end of the study period at 30 days

• Change in Substance Use as Measured by the Timeline Follow-Back (TLFB)

  From enrollment to the end of the study period at 30 days

• Change in Distress Tolerance Scale (DTS) Score

  From enrollment to the end of the study period at 30 days

Study Arms (1)

AVNT Intervention

EXPERIMENTAL

Participants receive auricular vagal neuromodulation therapy (AVNT) using the Parasym device. At the baseline visit, participants are trained on device use, electrode placement, and stimulation adjustment. Participants then self-administer AVNT at home for approximately 60 minutes daily over a 30-day study period. Stimulation is delivered to the auricular branch of the vagus nerve through an ear electrode placed on the tragus and is adjusted to a comfortable, perceptible level.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

Non-invasive transcutaneous auricular vagus nerve stimulation delivered using the Parasym device. Electrical stimulation is applied to the auricular branch of the vagus nerve through an ear electrode placed on the tragus.

AVNT Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide informed consent.
• to 60 years of age.
• History of substance use disorder involving illicit substances, such as opioids, stimulants, or sedatives.
• Currently enrolled in treatment for substance use disorder or actively seeking treatment.
• Score of 11 or greater on the Patient Health Questionnaire-9 (PHQ-9), indicating at least moderate depression symptoms.
• If taking medication for depression, anxiety, or sleep, on a stable dose for at least 2 weeks before the baseline visit, when feasible.
• Able to read, speak, and understand English well enough to complete study procedures and questionnaires.16 17• Willing and able to comply with study visits and study procedures for approximately 30 days.

You may not qualify if:

• Currently participating in another research study that includes an active treatment or intervention.
• Diagnosis of a neurological disorder, such as Parkinson's disease.
• Permanent implanted metal or electronic device near the ear, including certain hearing, heart, or nerve stimulation devices.
• Previous surgery involving the vagus nerve.
• Resting heart rate less than 50 beats per minute.
• Severe coronary artery disease or heart attack within the past 5 years.
• Active infection, skin condition, or skin breakdown on or near the outer ear where the device would be placed.
• History of trigeminal neuralgia within the past year.
• Pregnant, planning to become pregnant during the study, or suspected to be pregnant.
• Current severe or unstable psychiatric condition that would interfere with participation, such as active psychosis or acute suicidal risk.
• Acute intoxication or severe withdrawal symptoms at screening or baseline that would interfere with study participation.
• Significant abnormalities of the outer ear that would interfere with placement or use of the study device.
• Current use of another neuromodulation therapy, such as transcranial magnetic stimulation (TMS) or vagus nerve stimulation.
• Court-mandated addiction treatment.
• Incarcerated individuals.

Sponsors & Collaborators

• Daisy Thompson-Lake: lead
• Parasym Ltd.: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Neurobehavioral Sciences

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-07

Locations

US (1)