NCT05591703

Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Spark Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder
• Relapse

Interventions

Type	Name	Description
BEHAVIORAL	Clinical Outcomes and Questionnaires	Clinical patient-reported outcomes will be administered remotely at specified timepoints. No treatment or intervention will be administered in this protocol.

Timeline

• Start date: 2022-11-21
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2022-10-24
• Last updated: 2025-04-09

Locations

3 sites across 1 country: United States