Clinical trial NCT04075214: Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Official title: Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Withdrawal
Keywords: auricular neurostimulation
vagus nerve stimulation
transcutaneous
withdrawal symptoms
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.

Detailed description: Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study.

Eligibility criteria: Inclusion Criteria:

1. Current opioid dependence; prescriptive or non-prescriptive
2. COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
3. 18-65 years of age
4. English Proficiency
5. Participants must be able to provide informed con-sent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Current evidence of an uncontrolled and/or clinically significant medical condition
2. History of seizures or epilepsy
3. History of neurological diseases or traumatic brain injury
4. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
5. Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
6. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators
7. Abnormal ear anatomy or ear infection present
8. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
9. Females who are pregnant or lactating
10. 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: Clinical opiate withdrawal scale (COWS) score
timeFrame: 60 minutes
Secondary outcomes:
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 30 minutes
measure: Clinical opiate withdrawal scale (COWS) responder rate
timeFrame: 30 minutes
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 30 minutes
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: 120 minutes
measure: Clinical opiate withdrawal scale (COWS) score
timeFrame: Days 2-5
Other outcomes:
measure: Heart rate variability measured by R to R interval
timeFrame: Days 2-5
measure: C-reactive protein (CRP) levels
timeFrame: Day 5
measure: Cortisol levels
timeFrame: Day 5
measure: Cytokine levels
timeFrame: Day 5
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Day 5
measure: Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5)
timeFrame: Day 5
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Day 5
Locations:
city: Austin
country: United States
facility: Recovery Unplugged
state: Texas
Study officials:
affiliation: Spark Biomedical, Inc.
name: Navid Khodaparast, PhD
role: STUDY_DIRECTOR
References:
citation: Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.