- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04731935
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
August 17, 2021 updated by: Spark Biomedical, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
6
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
-
-
Texas
-
Austin, Texas, United States, 78745
- Recovery Unplugged
-
-
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
16 years to 63 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 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tAN Therapy
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.
|
Transcutaneous auricular neurostimulation
|
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 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
|
Mean percent change in COWS score from baseline to 30 minutes after start of tAN therapy.
|
30 minutes
|
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.
|
120 minutes
|
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.
|
Days 2-5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Days 2-5
|
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
|
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.
|
Day 5
|
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.
|
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.
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)
March 18, 2021
Primary Completion (Actual)
May 26, 2021
Study Completion (Actual)
May 26, 2021
Study Registration Dates
First Submitted
January 27, 2021
First Submitted That Met QC Criteria
January 27, 2021
First Posted (Actual)
February 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBM-OWP-04
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.
No
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.
Clinical Trials on Opioid-use Disorder
-
Aurora Health CareUniversity of Chicago; University of California, Santa Cruz; Rogers Behavioral...RecruitingSubstance Use | Methamphetamine-dependence | Opioid Use | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Use | Methamphetamine AbuseUnited States
-
Hennepin Healthcare Research InstituteNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCRecruitingSubstance Use Disorder | Opioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Hennepin Healthcare Research InstituteNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCRecruitingSubstance Use Disorders | Opioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Vanderbilt University Medical CenterCompletedOpioid Use | Opioid-use DisorderUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Albert Einstein College of MedicineNational Institute on Drug Abuse (NIDA); Pfizer; National Institutes of Health...Active, not recruitingTobacco Use Disorder | Opioid-use DisorderUnited States
-
Indiana UniversityCompletedOpioid Use | Opioid-use DisorderUnited States
-
University of ZurichCompletedOpioid Use, Unspecified With Other Opioid-induced DisorderSwitzerland
-
Virginia Commonwealth UniversityNational Institute on Drug Abuse (NIDA)CompletedOpioid-use Disorder | Cocaine Use Disorder | Healthy Controls | Marijuana Use DisorderUnited States
-
New York State Psychiatric InstituteColumbia University; Weill Medical College of Cornell University; National Institute... and other collaboratorsActive, not recruitingOpioid Use | Opioid Court Model | Medication to Treat Opioid Use DisorderUnited States
Clinical Trials on Sparrow Therapy System
-
Spark Biomedical, Inc.Medical University of South Carolina; University of Texas Southwestern Medical...RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
-
University of CincinnatiSpark Biomedical, Inc.Not yet recruitingOpioid Use Disorder | Posttraumatic Stress DisorderUnited States
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingUnderstanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic PainAnalgesia | Opioid WithdrawalUnited States
-
University of Texas Southwestern Medical CenterNot yet recruitingPain, Postoperative | Opioid Use | Lumbar Spine InjuryUnited States
-
Spark Biomedical, Inc.Hazelden Betty Ford Foundation; Gaudenzia, Inc.RecruitingOpioid-use Disorder | Opioid WithdrawalUnited States
-
University of North Carolina, GreensboroCompleted
-
Regenesis Biomedical, Inc.CompletedDiabetic Neuropathy PeripheralUnited States
-
Regenesis Biomedical, Inc.CompletedDiabetic Peripheral NeuropathyUnited States
-
Cyberonics, Inc.Completed
-
Cyberonics, Inc.PRA Health SciencesCompletedEpilepsyNorway, Germany, United Kingdom, Belgium, Netherlands