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Auricular Vagal Neuromodulation for Depression and Anxiety in Substance Use Disorder

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will use a handheld device that delivers mild electrical stimulation to the ear for approximately 60 minutes each day over 30 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether adults in treatment for substance use disorder can use an ear stimulation device at home and find it easy and comfortable to use. The handheld device sends mild electrical pulses to the ear for about 60 minutes a day for 30 days. Researchers will also look for changes in depression, anxiety, sleep problems, and drug cravings.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 60 years old.
  • You can and want to give informed consent, meaning you understand and agree to join the study.
  • You have a history of problems with illegal drug use, such as opioids, stimulants, or sedatives.
  • You are in treatment for substance use disorder or are actively seeking treatment.
  • You score at least 11 on the PHQ-9 depression survey, showing at least moderate depression symptoms.
  • If you take medicine for depression, anxiety, or sleep, your dose has stayed the same for at least 2 weeks before the first study visit, when possible.
  • You can read, speak, and understand English well enough to complete the study tasks and surveys.
  • You are willing and able to follow study steps and attend visits for about 30 days.

Who can't join

  • You are in another study with an active treatment, or you currently use another nerve or brain stimulation treatment.
  • You have a nervous system disorder, such as Parkinson’s disease; had surgery on the vagus nerve; or had trigeminal neuralgia, a condition causing severe face pain, within the past year.
  • You have a permanent metal or electronic implant near the ear, or an ear infection, skin problem, open sore, or ear shape that would prevent device use.
  • Your resting heart rate is below 50 beats per minute, you have severe disease in the arteries supplying your heart, or you had a heart attack within the past 5 years.
  • You are pregnant, may be pregnant, or plan to become pregnant during the study.
  • You have a severe or unstable mental health condition that would prevent participation, such as losing touch with reality or an immediate risk of suicide. Being under the influence of drugs or having severe withdrawal at screening or the first visit also rules you out if it would prevent participation.
  • You are in court-ordered addiction treatment or are in jail or prison.
  • You cannot give informed consent or follow study steps, or the researcher believes a health or life situation would make the study unsafe for you or affect its results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

VA