Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Not Applicable

Completed

• Conditions: Opioid-use Disorder; Opioid Withdrawal
• Interventions: Device: transcutaneous auricular neurostimulation (tAN)

• Registration Number: NCT04075214
• Lead Sponsor: Spark Biomedical, Inc.

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.

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 Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2019-11-19
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Current opioid dependence; prescriptive or non-prescriptive
2. COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
3. 18-65 years of age
4. English Proficiency
5. Participants must be able to provide informed con-sent and function at an intellectual level sufficient for study requirements

Exclusion Criteria

1. Current evidence of an uncontrolled and/or clinically significant medical condition
2. History of seizures or epilepsy
3. History of neurological diseases or traumatic brain injury
4. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
5. Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
6. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators
7. Abnormal ear anatomy or ear infection present
8. 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
9. Females who are pregnant or lactating
10. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed-active tAN	transcutaneous auricular neurostimulation (tAN)	-
active tAN	transcutaneous auricular neurostimulation (tAN)	-

Primary Outcome Measures

Name	Time	Method
Clinical opiate withdrawal scale (COWS) score	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.

Secondary Outcome Measures

Name	Time	Method
Clinical opiate withdrawal scale (COWS) responder rate	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
Clinical opiate withdrawal scale (COWS) score	Days 2-5	Mean percent change in COWS score from baseline to Days 2 through 5 after start of active tAN therapy

Trial Locations

Locations (1)

Recovery Unplugged; 🇺🇸 Austin, Texas, United States