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.
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.
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.
Single group
Transcutaneous Auricular Vagus Nerve Stimulation
DeviceNon-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.
Recruitment Rate
Number of participants enrolled divided by the number of participants screened for eligibility.
Retention Rate
Percentage of enrolled participants who remain active in the study through the Day 30 follow-up assessment.
Study Completion Rate
Percentage of enrolled participants who complete all required end-of-study assessments at Day 30.
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.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Change in depression symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Change in anxiety symptom severity as measured by the Generalized Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Change in Substance Use as Measured by the Timeline Follow-Back (TLFB)
Change in self-reported substance use as measured by the Timeline Follow-Back (TLFB). The TLFB estimates the frequency and quantity of substance use over a specified period, with higher values indicating greater substance use.
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