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

Spark Biomedical

Status: Completed

Conditions: Opioid Withdrawal; Opioid-use Disorder

Treatments: Device: Sparrow Therapy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04731935

SBM-OWP-04

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

tAN Therapy

Experimental group

Description:

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.

Treatment:

Device: Sparrow Therapy System