Clinical trial NCT05591703: Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
Official title: Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use Disorder
Relapse
Keywords: relapse prevention
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hazelden Betty Ford Foundation
First posted: 2022-10-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of dependence on prescription or non-prescription opioids

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants in Phase II with a relapse event
timeFrame: 12 months (total duration of trial)
Secondary outcomes:
measure: Proportion of participants in either Phase I or Phase II with a relapse event
timeFrame: 12 months (total duration of trial)
measure: Mean change in recovery capital measured by Brief Assessment of Recovery Capital (BARC-10)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in opioid craving measured by the Opioid Craving Scale (OCS)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in protracted withdrawal symptoms measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in depression symptoms across time measured by Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in anxiety across time measured by Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in PTSD symptoms across time measured by the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in Quality of Life across time measured by World Health Organization Quality of Life(WHOQOL-BREF) domain scores
timeFrame: Baseline to Study Completion (12 months)
measure: Mean change in Commitment to Sobriety Scale (CSS-5)
timeFrame: Baseline to Study Completion (12 months)
Other outcomes:
measure: Record traumatic life events measured by the Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Baseline to Study Completion (12 months)
measure: Record self-report of peer recovery support engagement
timeFrame: Baseline to Study Completion (12 months)
measure: Record self-report of MOUD prevalence and adherence
timeFrame: Baseline to Study Completion (12 months)
measure: Proportion of participants who qualify for a change in ICD-10 code
timeFrame: Baseline to Study Completion (12 months)
Locations:
city: Rancho Mirage
country: United States
facility: Betty Ford Foundation
state: California
city: Center City
country: United States
facility: Hazelden Betty Ford Foundation
state: Minnesota
city: Plymouth
country: United States
facility: Hazelden Betty Ford Foundation
state: Minnesota
Study officials:
References: