Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Study Overview
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Brief Summary
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The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

Detailed Description
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This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.

Official Title
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A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal

Conditions
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Opioid-use Disorder, Opioid Withdrawal

Intervention / Treatment
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* Device: Sparrow Therapy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current opioid dependence; prescriptive or non-prescriptive COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal 18-65 years of age English proficiency Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements Exclusion Criteria: Current evidence of an uncontrolled and/or clinically significant medical condition History of seizures or epilepsy History of neurological diseases or traumatic brain injury Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators) Abnormal ear anatomy or ear infection present Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study Females who are pregnant or lactating Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tAN Therapy<br>tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for a total of 120 hours (5 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. | Device: Sparrow Therapy System<br>* Transcutaneous auricular neurostimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical opiate withdrawal scale (COWS) score | Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical opiate withdrawal scale (COWS) score | Mean percent change in COWS score from baseline to 30 minutes after start of tAN therapy. | 30 minutes | 
| Clinical opiate withdrawal scale (COWS) score | Mean percent change in COWS score from baseline to 120 minutes after start of tAN therapy. | 120 minutes | 
| Clinical opiate withdrawal scale (COWS) score | Mean percent change in COWS score from baseline to Days 2 through 5 after start of tAN therapy. | Days 2-5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms