Substance Use Disorder (SUD)
Conditions
Brief 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.
Interventions
DEVICETranscutaneous 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.
Sponsors
Daisy Thompson-Lake
Parasym Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From enrollment to the end of treatment at 30 days | Number of participants enrolled divided by the number of participants screened for eligibility. |
| Retention Rate | From enrollment to the end of treatment at 30 days | Percentage of enrolled participants who remain active in the study through the Day 30 follow-up assessment. |
| Study Completion Rate | From enrollment to the end of treatment at 30 days | Percentage of enrolled participants who complete all required end-of-study assessments at Day 30. |
| Adherence to AVNT Device Use | From enrollment to the end of treatment at 30 days | Percentage of prescribed AVNT sessions completed during the 30-day study period, based on participant-reported device use and/or device usage records. |
| Participant-Reported Tolerability of AVNT Using the AVNT Tolerability Assessment | From enrollment to the end of treatment at 30 days | 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. |
| Device Return Rate | From enrollment to the end of treatment at 30 days | Percentage of participants who return study-issued AVNT devices at the end-of-study visit or upon withdrawal from the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | From enrollment to the end of the study period at 30 days | 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 | From enrollment to the end of the study period at 30 days | 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 | From enrollment to the end of the study period at 30 days | 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) | From enrollment to the end of the study period at 30 days | 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. |
| Change in Distress Tolerance Scale (DTS) Score | From enrollment to the end of the study period at 30 days | 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. |
| Change in Neuro-QoL Domain Scores | From enrollment to the end of the study period at 30 days | 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. |
| Change in Craving Ratings During the Cue Reactivity Craving Task | From enrollment to the end of the study period at 30 days | 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. |
Countries
United States
Outcome results
None listed