Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04731935
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2021-01-27
Brief Title:
Novel Earpiece for Transcutaneous Auricular Neurostimulation tAN for Symptoms of Opioid Withdrawal
Sponsor:
Spark Biomedical Inc
Organization:
Spark Biomedical Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None