Substance Use Disorder (SUD)NCT07814755
Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Substance Use Disorder (SUD), run by Daisy Thompson-Lake at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Daisy Thompson-Lake, PhD, 434-297-4423, daisy.thompson-lake@uvahealth.org
James Mahoney, PhD, JJM5EJ@uvahealth.org
About this study
Official title: Auricular Vagal Neuromodulation Therapy (AVNT™) for the Alleviation of Depression and Anxiety in Substance Use Disorder
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)
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled divided by the number of participants screened for eligibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 30 days
Secondary outcomes (7)
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.
Measured: From enrollment to the end of the study period at 30 days
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.
Measured: From enrollment to the end of the study period at 30 days
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.
Measured: From enrollment to the end of the study period at 30 days
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.
Measured: From enrollment to the end of the study period at 30 days
Change in Distress Tolerance Scale (DTS) Score
Change in distress tolerance as measured by the Distress Tolerance Scale (DTS). Total scores range from 15 to 75, with higher scores indicating greater ability to tolerate emotional distress.
Measured: From enrollment to the end of the study period at 30 days
Change in Neuro-QoL Domain Scores
Change in quality of life as measured by Neuro-QoL domain T-scores. Neuro-QoL scores are standardized to a reference population with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the domain being measured. For anxiety, depression, stigma, and sleep disturbance domains, higher scores indicate worse symptoms.
Measured: From enrollment to the end of the study period at 30 days
Change in Craving Ratings During the Cue Reactivity Craving Task
Change in participant-reported craving in response to substance-related cues. Craving ratings range from 0 (no craving) to 100 (strongest craving possible), with higher scores indicating greater craving.
Measured: From enrollment to the end of the study period at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daisy Thompson-Lake
- Sponsor type
- University, hospital or other
- Collaborators
- Parasym Ltd.
- Responsible party
- Sponsor-investigator, Daisy Thompson-Lake, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814755
- Sponsor's protocol ID
- 303501
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes