Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

NCT04075214 | Completed FDA Device

• 1 other identifier: SBM-OWP-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Opioid Withdrawal

Keywords

auricular neurostimulation; vagus nerve stimulation; transcutaneous; withdrawal symptoms

Outcome Measures

Primary Outcomes (1)

• Clinical opiate withdrawal scale (COWS) score

  Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of active tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.

  60 minutes

Secondary Outcomes (5)

• Clinical opiate withdrawal scale (COWS) score

  30 minutes

• Clinical opiate withdrawal scale (COWS) responder rate

  30 minutes

• Clinical opiate withdrawal scale (COWS) score

  30 minutes

• Clinical opiate withdrawal scale (COWS) score

  120 minutes

• Clinical opiate withdrawal scale (COWS) score

  Days 2-5

Other Outcomes (7)

• Heart rate variability measured by R to R interval

  Days 2-5

• C-reactive protein (CRP) levels

  Day 5

• Cortisol levels

  Day 5

Study Arms (2)

delayed-active tAN

SHAM COMPARATOR

Device: transcutaneous auricular neurostimulation (tAN)

active tAN

EXPERIMENTAL

Device: transcutaneous auricular neurostimulation (tAN)

Interventions

transcutaneous auricular neurostimulation (tAN) DEVICE

Phoenix tAN system

active tAN; delayed-active tAN

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Current evidence of an uncontrolled and/or clinically significant medical condition
• History of seizures or epilepsy
• History of neurological diseases or traumatic brain injury
• Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
• Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
• Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators
• Abnormal ear anatomy or ear infection present
• 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
• Females who are pregnant or lactating
• 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

Study Sites (1)

Recovery Unplugged

Austin, Texas, 78745, United States

Location

Related Publications (1)

• 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.

  PMID: 35978394 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Navid Khodaparast, PhD

  Spark Biomedical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: November 19, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)