Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-29 @ 9:57 PM
Study NCT ID:
NCT05591703
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
Sponsor:
Spark Biomedical, Inc.
Organization:
Study Overview
Official Title:
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
Status:
COMPLETED
Status Verified Date:
2025-04
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:
RESTOREb
Brief Summary:
This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE; ClinicalTrials.gov Identifier: NCT05053503). Clinical outcome scores will be collected at study exit from protocol SBM-OWP-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol SBM-OWP-03.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: