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OpenTrials
Completed

NCT Number: NCT04731935

Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Withdrawal Opioid-Related Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recovery Unplugged

Austin, Texas, 78745, United States

About this study

This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 18-65 years of age
  • English proficiency
  • Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion criteria

  • 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., pacemakers, cochlear prosthesis, neurostimulators)
  • Abnormal ear anatomy or ear infection present
  • Women of childbearing potential not using adequate contraception as per investigator judgement 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

Treatment and study plan

Sparrow Therapy System

Device

Transcutaneous auricular neurostimulation

Primary outcomes

  1. Clinical opiate withdrawal scale (COWS) score

    Time frame: 60 minutes

    Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of 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.

Secondary outcomes

  1. Clinical opiate withdrawal scale (COWS) score

    Time frame: 30 minutes

    Mean percent change in COWS score from baseline to 30 minutes after start of tAN therapy.

  2. Clinical opiate withdrawal scale (COWS) score

    Time frame: 120 minutes

    Mean percent change in COWS score from baseline to 120 minutes after start of tAN therapy.

  3. Clinical opiate withdrawal scale (COWS) score

    Time frame: Days 2-5

    Mean percent change in COWS score from baseline to Days 2 through 5 after start of tAN therapy.

Other outcomes

  1. Heart rate variability measured by R to R interval

    Time frame: Days 2-5

    Mean change from baseline to Days 2-5 in heart rate variability measured by R to R interval.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Day 5

    Mean change in depression symptoms measured by Patient Health Questionnaire (PHQ-9) total score from baseline to Day 5. The PHQ-9 is a nine-item depression scale 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.

  3. Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5)

    Time frame: Day 5

    Mean change in PTSD symptoms measured by the PTSD Checklist for DSM-5 (PCL-5) total symptom severity score from baseline to Day 5. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. 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 a10-20 point reduction in score represents a clinically significant change in PTSD symptoms.

  4. World Health Organization Quality of Life - BREF (WHOQOL-BREF)

    Time frame: Day 5

    Mean change in WHOQOL-BREF domain scores (physical health, psychological health, social relationships, environment, and overall QoL/general health) from baseline to Day 5. The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a 26-item, self-report questionnaire which assesses 4 quality of life domains: physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall quality of life and general health. Subjects rate how much they have experienced each item in the preceding 2 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. Raw domain scores will be converted to a 0 to 100 scale.

Sponsors and collaborators

Lead sponsor

Spark Biomedical, Inc.

Industry

Registry information

Official study title

A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation to Improve Symptoms Associated With Opioid Withdrawal

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2021
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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