Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Daisy Thompson-Lake
Study ID
NCT07814755
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AVNT Intervention
    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.

Primary Outcome Measure

Recruitment Rate [ Time Frame: From enrollment to the end of treatment at 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Daisy Thompson-Lake, PhD
[email protected]
434-297-4423
James Mahoney, PhD
[email protected]
Daisy Thompson-Lake, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By research site
University of Virginia· Charlottesville, VA

Related Studies