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

NCT ID: NCT04731935

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2021-05-26

Brief Summary

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

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.

Conditions

Opioid-use Disorder; Opioid Withdrawal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tAN Therapy

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.

Group Type: EXPERIMENTAL

Sparrow Therapy System

Intervention Type: DEVICE

Transcutaneous auricular neurostimulation

Interventions

Sparrow Therapy System

Transcutaneous auricular neurostimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spark Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Navid Khodaparast, PhD

Role: STUDY_DIRECTOR

Spark Biomedical, Inc.

Locations

Recovery Unplugged

Austin, Texas, United States

Countries

United States

Other Identifiers

SBM-OWP-04

Identifier Type: -

Identifier Source: org_study_id