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NOT YET RECRUITING

NCT07814755

Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

Sponsor: Daisy Thompson-Lake

View on ClinicalTrials.gov

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.

Official title: Auricular Vagal Neuromodulation Therapy (AVNT™) for the Alleviation of Depression and Anxiety in Substance Use Disorder

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2029-10

Last Updated

2026-09-11

Healthy Volunteers

Conditions

Substance Use Disorder (SUD)

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

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.

Inclusion Criteria: * Able and willing to provide informed consent. * 18 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. Exclusion Criteria: * 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. * Unable to provide informed consent or comply with study procedures. * Any medical, psychiatric, or social condition that, in the opinion of the investigator, would make participation unsafe or interfere with study results.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States