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

Opioid-use Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04731935
Study type Interventional
Source Spark Biomedical, Inc.
Contact
Status Completed
Phase N/A
Start date March 18, 2021
Completion date May 26, 2021
View Details
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