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

Completed

Conditions studied: Opioid Use Disorder, Relapse

In brief

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.

Key facts

Study ID

NCT05591703

Run by

Spark Biomedical, Inc.

People needed

32

Starts

2022-11-21

Expected to finish

2025-01-31

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consented participant for protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE)
• Participant is English proficient
• Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

You may not qualify if…

• Participant is unable to reliably receive and respond to assessments via email or telephone
• Participant has 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

Where it is running

• Betty Ford Foundation — Rancho Mirage, California, United States
• Hazelden Betty Ford Foundation — Center City, Minnesota, United States
• Hazelden Betty Ford Foundation — Plymouth, Minnesota, United States

Full record on ClinicalTrials.gov

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