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

Spark Biomedical

Status: Completed

Conditions: Opioid Use Disorder; Relapse

Treatments: Behavioral: Clinical Outcomes and Questionnaires

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05591703

SBM-OWP-03b

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Participant is unable to reliably receive and respond to assessments via email or telephone
2. 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

Trial design

32 participants in 2 patient groups

Participants randomized to receive tAN therapy in SBM-OWP-03 Phase II

Treatment:

Behavioral: Clinical Outcomes and Questionnaires

Participants not randomized to receive tAN therapy in SBM-OWP-03 Phase II

Treatment:

Behavioral: Clinical Outcomes and Questionnaires