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

NCT05591703 | Completed

• 1 other identifier: SBM-OWP-03b
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Use Disorder; Relapse

Keywords

relapse prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of participants in Phase II with a relapse event

  12 months (total duration of trial)

Secondary Outcomes (9)

• Proportion of participants in either Phase I or Phase II with a relapse event

  12 months (total duration of trial)

• Mean change in recovery capital measured by Brief Assessment of Recovery Capital (BARC-10)

  Baseline to Study Completion (12 months)

• Mean change in opioid craving measured by the Opioid Craving Scale (OCS)

  Baseline to Study Completion (12 months)

• Mean change in protracted withdrawal symptoms measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)

  Baseline to Study Completion (12 months)

• Mean change in depression symptoms across time measured by Patient Health Questionnaire (PHQ-9)

  Baseline to Study Completion (12 months)

Other Outcomes (4)

• Record traumatic life events measured by the Life Events Checklist for DSM-5 (LEC-5)

  Baseline to Study Completion (12 months)

• Record self-report of peer recovery support engagement

  Baseline to Study Completion (12 months)

• Record self-report of MOUD prevalence and adherence

  Baseline to Study Completion (12 months)

Study Arms (2)

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

Behavioral: Clinical Outcomes and Questionnaires

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

Behavioral: Clinical Outcomes and Questionnaires

Interventions

Clinical Outcomes and Questionnaires BEHAVIORAL

Clinical patient-reported outcomes will be administered remotely at specified timepoints. No treatment or intervention will be administered in this protocol.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a history of dependence on prescription or non-prescription opioids

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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Hazelden Betty Ford Foundation: collaborator

Study Sites (3)

Betty Ford Foundation

Rancho Mirage, California, 92270, United States

Location

Hazelden Betty Ford Foundation

Center City, Minnesota, 55012, United States

Location

Hazelden Betty Ford Foundation

Plymouth, Minnesota, 55441, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Recurrence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: November 21, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)