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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder; Relapse
• Intervention / Treatment: Behavioral: Clinical Outcomes and Questionnaires

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Betty Ford Foundation
  • Minnesota
    • Center City, Minnesota, United States, 55012
      • Hazelden Betty Ford Foundation
    • Plymouth, Minnesota, United States, 55441
      • Hazelden Betty Ford Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants randomized to receive tAN therapy in SBM-OWP-03 Phase II	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.
Participants not randomized to receive tAN therapy in SBM-OWP-03 Phase II	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants in Phase II with a relapse event	12 months (total duration of trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants in either Phase I or Phase II with a relapse event	Comparison of the proportion of participants in either Phase I or Phase II with a relapse event over the 12-month follow-up period	12 months (total duration of trial)
Mean change in recovery capital measured by Brief Assessment of Recovery Capital (BARC-10)	The BARC-10 is a short,10-item measure that examines recovery capital globally. Items were selected from the ARC for the BARC-10 using item response theory. The BARC-10 measures a unidimensional (i.e., global) construct of recovery capital across all the original 10 domains of the ARC. On average, it takes 2-5 minutes to complete. Scores range from 6-60. Individuals who have a recovery capital score of 47 or higher are likely to reach or sustain a year or longer of recovery from substance use disorder.	Baseline to Study Completion (12 months)
Mean change in opioid craving measured by the Opioid Craving Scale (OCS)	Participants are asked to answer the following three questions with responses ranging from 0-10, where 0=Not at all and 10=Extremely. Total possible score ranges from 0-30 with greater scores indicating higher opioid craving: (1) How much do you currently crave opiates? (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (example: seeing a medication bottle, using the Internet, visiting a doctor's office, going to a place where you used to buy drugs)? (3) Please imagine yourself in the environment in which you previously used opiates (examples: a party, a hangout, a particular room where you live). If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today?	Baseline to Study Completion (12 months)
Mean change in protracted withdrawal symptoms measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)	The SOWS-Gossop is an appropriate, precise, and sensitive measure to evaluate the symptoms of acute opioid withdrawal in research or clinical settings. The scale was derived from the original 32-item Opiate Withdrawal Scale to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The assessment is a self-administered test used for the assessment of opiate withdrawal symptoms. The scale contains ten items: yawning, muscular tension, runny eyes, muscle twitching, pains, and aches, feeling of coldness, stomach cramps, insomnia, heart pounding, and feeling sick, making it easy and rapid to administer. The tool has a 4-point rating scale: 0 for 'none,' 1 for 'mild,' 2 for 'moderate,' and 3 for 'severe', with scores ranging from 0 to 30.	Baseline to Study Completion (12 months)
Mean change in depression symptoms across time measured by Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a validated tool in mental health and considered a powerful tool to assist clinicians with diagnosing depression and monitoring treatment response. The relationship between opioid use and depression is bidirectional. The PHQ-9 is a nine-item depression scale and is based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Each of the nine items is rated on a 0 (not at all) to 3 (nearly every day) scale. A total score is calculated by summing the nine items. Scores range from 0 to 27 and higher scores indicate a higher degree of depression.	Baseline to Study Completion (12 months)
Mean change in anxiety across time measured by Generalized Anxiety Disorder (GAD-7)	The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research. The questionnaire consists of 7 questions in which participants are asked to rate each item on a 0 (not at all) to 3 (nearly every day). GAD-7 total score for the seven items ranges from 0 to 21 where 0-4 represents minimal anxiety, 5-9 represents mild anxiety, 10-14 represents moderate anxiety and 15-21 represent severe anxiety.	Baseline to Study Completion (12 months)
Mean change in PTSD symptoms across time measured by the PTSD Checklist for DSM-5 (PCL-5)	Symptoms of post-traumatic stress disorder (PTSD) and opiate dependency may overlap, to which, opioid withdrawal symptoms may emulate PTSD hyperactive startle response. This is indicative a common physiological mechanism. The PCL-5 scale is the gold standard in PTSD assessment. It consisted of a 20-item self-report measurement that is capable of measuring symptom change during and after treatment. Additionally, the scale can provide a provisional PTSD diagnosis. Each of the 20 items is rated on a 0 (not at all) to 4 (extremely) scale. A total symptom severity score is calculated by summing the 20 items. Scores range from 0 and 80 and higher scores indicating a higher degree of PTSD symptomology. Evidence suggests that a10 to 20-point reduction in score represents a clinically significant change in PTSD symptoms.	Baseline to Study Completion (12 months)
Mean change in Quality of Life across time measured by World Health Organization Quality of Life(WHOQOL-BREF) domain scores	The WHOQOL-BREF is a shorter version of the original assessment tool and is commonly used in clinical trials with participants undergoing substance use disorder intervention. The WHOQOL-BREF is comprised of 26-items and assesses the participant's quality of life across specific domains: physical health, psychological health, social relationships, and environment.24 In addition, there are 2 items that measure overall quality of life and general health. Participants rate how much they have experienced each item in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction with higher scores denoting higher quality of life. The mean score of items within each domain is used to calculate the domain score. Raw domain scores will be converted to a 0 to 100 scale.	Baseline to Study Completion (12 months)
Mean change in Commitment to Sobriety Scale (CSS-5)	Ratings of participant-perceived level of motivation and dedication to achieving initial and maintaining on-going sobriety for substance use will be measured using the 5-item Commitment to Sobriety Scale (CSS-5). Each statement is rated on a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree). Example items include: "Staying sober is the most important thing in my life" and "I will do whatever it takes to recover from my addiction." Following the completion of the CSS-5, participants will be asked to reflect and rate level of confidence on their commitment to abstinence for the next 30 days using a 10-point scale, from 1 (not at all confident) to 10, (very confident).	Baseline to Study Completion (12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record traumatic life events measured by the Life Events Checklist for DSM-5 (LEC-5)	The Life Events Checklist for DSM-5 (LEC-5) is a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.	Baseline to Study Completion (12 months)
Record self-report of peer recovery support engagement	Participants will be asked about their engagement in peer recovery support groups through one-item: "How often have you attended peer recovery support groups or services (examples include, formal peer recovery support services, 12-step meetings, faith-based recovery support, SMART recovery, and other mutual-aid groups engagement) since your last survey date?" Participants will be given a 6-point ordinal response scale: Daily, Four or more times per week, One to three times per week, Two to four times per month, Once a month or less, or Never.	Baseline to Study Completion (12 months)
Record self-report of MOUD prevalence and adherence	Participants will be asked if they are currently receiving MOUD treatment. For those that are, follow up questions will ask participants to report on type and kind of medication they are taking, as well as their current adherence and rationale for any reported deterrence from physician-prescribed treatment. "Do you have a prescription for an anti-craving medication?"; "Which of the following medications are you currently prescribed?". Example items related to adherence: "Have you been able to take your medication as prescribed?", "Which of the following medications have you NOT taken as prescribed?", and "What is the reason that you have not taken your anti-craving medication as prescribed?" For adherence rationale, respondents are given five response options, including an Other category in which they can provide a short answer option unique to their situation.	Baseline to Study Completion (12 months)
Proportion of participants who qualify for a change in ICD-10 code	Responses to the above questionnaires will be reviewed against the DSM-5 and ICD-10 code definitions. If a participant qualified for a change in ICD-10 code, the original and projected ICD-10 code changes will be recorded.	Baseline to Study Completion (12 months)

Collaborators and Investigators

• Sponsor: Spark Biomedical, Inc.
• Collaborators: Hazelden Betty Ford Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: relapse prevention
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Pathologic Processes; Disease Attributes; Substance-Related Disorders; Chemically-Induced Disorders; Recurrence; Opioid-Related Disorders
• Other Study ID Numbers: SBM-OWP-03b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No