- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075214
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
August 17, 2021 updated by: Spark Biomedical, Inc.
Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Austin, Texas, United States, 78745
- Recovery Unplugged
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 con-sent 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. 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: delayed-active tAN
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Phoenix tAN system
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Experimental: active tAN
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Phoenix tAN system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical opiate withdrawal scale (COWS) score
Time Frame: 30 minutes
|
Comparison of mean percent change in COWS score in delayed active tAN versus active tAN groups at 30 minutes
|
30 minutes
|
Clinical opiate withdrawal scale (COWS) responder rate
Time Frame: 30 minutes
|
Comparison of the proportion of participants with a clinically significant reduction in COWS score (defined as a 15% or greater reduction) in delayed-active tAN versus active tAN groups at 30 minutes
|
30 minutes
|
Clinical opiate withdrawal scale (COWS) score
Time Frame: 30 minutes
|
Mean percent change in COWS score from baseline to 30 minutes after start of active tAN therapy
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30 minutes
|
Clinical opiate withdrawal scale (COWS) score
Time Frame: 120 minutes
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Mean percent change in COWS score from baseline to 120 minutes after start of active tAN therapy
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120 minutes
|
Clinical opiate withdrawal scale (COWS) score
Time Frame: Days 2-5
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Mean percent change in COWS score from baseline to Days 2 through 5 after start of active tAN therapy
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Days 2-5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 5
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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.
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Day 5
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World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time Frame: Day 5
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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.
|
Day 5
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Heart rate variability measured by R to R interval
Time Frame: Days 2-5
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Mean change from baseline to Days 2-5 in heart rate variability measured by R to R interval
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Days 2-5
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C-reactive protein (CRP) levels
Time Frame: Day 5
|
Mean change in C-reactive protein (CRP) levels from baseline to Day 5
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Day 5
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Cortisol levels
Time Frame: Day 5
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Mean change in cortisol levels from baseline to Day 5
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Day 5
|
Cytokine levels
Time Frame: Day 5
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Mean change in cytokine levels from baseline to Day 5
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Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Navid Khodaparast, PhD, Spark Biomedical, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2019
Primary Completion (Actual)
December 14, 2020
Study Completion (Actual)
December 14, 2020
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 30, 2019
Study Record Updates
Last Update Posted (Actual)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBM-OWP-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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