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

Primary Purpose

Opioid-use Disorder, Opioid Withdrawal

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sparrow Therapy System

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Recovery Unplugged

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tAN Therapy

Arm Description

tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for a total of 120 hours (5 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness.

Outcomes

Primary Outcome Measures

Clinical opiate withdrawal scale (COWS) score

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 Outcome Measures

Clinical opiate withdrawal scale (COWS) score

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

Clinical opiate withdrawal scale (COWS) score

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

Clinical opiate withdrawal scale (COWS) score

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

Full Information

NCT ID

NCT04731935

First Posted

January 27, 2021

Last Updated

August 17, 2021

Sponsor

Spark Biomedical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04731935

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 18, 2021 (Actual)

Primary Completion Date

May 26, 2021 (Actual)

Study Completion Date

May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spark Biomedical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder, Opioid Withdrawal

Keywords

auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tAN Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Sparrow Therapy System

Intervention Description

Transcutaneous auricular neurostimulation

Primary Outcome Measure Information:

Title

Clinical opiate withdrawal scale (COWS) score

Description

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Clinical opiate withdrawal scale (COWS) score

Description

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

Time Frame

30 minutes

Title

Clinical opiate withdrawal scale (COWS) score

Description

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

Time Frame

120 minutes

Title

Clinical opiate withdrawal scale (COWS) score

Description

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

Time Frame

Days 2-5

Other Pre-specified Outcome Measures:

Title

Heart rate variability measured by R to R interval

Description

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

Time Frame

Days 2-5

Title

Patient Health Questionnaire (PHQ-9)

Description

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.

Time Frame

Day 5

Title

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

Description

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.

Time Frame

Day 5

Title

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

Description

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.

Time Frame

Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Navid Khodaparast, PhD

Organizational Affiliation

Spark Biomedical, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Recovery Unplugged

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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