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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-21

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

NCT05053503

Opioid-use Disorder Opioid Withdrawal

COMPLETED NA

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

NCT05336188

RECRUITING PHASE2

Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

NCT05903495

Opioid-Related Disorders

COMPLETED NA

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

NCT04464980

Opioid Use Disorder (OUD)

ACTIVE_NOT_RECRUITING PHASE2

Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

NCT04075214

Opioid-use Disorder Opioid Withdrawal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Clinical Outcomes and Questionnaires

Intervention Type 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

Clinical Outcomes and Questionnaires

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No