Understanding Transcutaneous Auricular Neurostimulation for Chronic Pain

This study is looking at how a device called transcutaneous auricular neurostimulation (tAN), worn on the ear, might help people with chronic pain who are reducing their opioid medication. The device works by stimulating nerves around the ear, which is thought to change signals in the brain. Researchers want to see if this device can reduce pain and withdrawal symptoms. You would be asked to reduce your pain medication and then spend several days and nights at the Clinical Research Center at UTMB in Galveston. During this time, you would receive either active tAN stimulation or a sham (inactive) stimulation, and researchers would monitor your withdrawal symptoms. The study aims to enroll 60 participants aged 18 to 65 who have experienced pain for more than six months and have a prescription for pain medication.

Study design
This is an interventional study comparing active transcutaneous auricular neurostimulation (tAN) to sham tAN. It plans to enroll 60 participants.
What's involved
You would be asked to reduce your pain medication and then spend several days and nights at the Clinical Research Center at UTMB in Galveston. Withdrawal symptoms would be monitored, and you would receive either active or sham stimulation.
Compensation
Not stated in the trial record.
Follow-up
Withdrawal symptoms will be measured on day 1 and day 4.

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NCT05555485

Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain

Recruiting
NAAges 18–65InterventionalTreatment
The University of Texas Medical Branch, Galveston
~60 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:transcutaneous Auricular neurostimulation - Activetranscutaneous auricular neurostimulation - Sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical opioid withdrawal scale (COWS)
Measured over day 1 and day 4
Opioid Withdrawal
Analgesia
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

Males and females between 18 and 65 years of age
Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Presence of pain on more than half of the days in the last six months
Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP)
Willingness to taper opioid dose by at least 10%
Patient or provider requests opioid dose reduction or discontinuation.
Urine Drug Screen (UDS) must be positive for their prescribed opioid
Urine Drug Test must be negative for illicit drugs, benzodiazepines, and nonprescribed opioids
Must agree to use nicotine patches and/or gum instead of smoking or vaping in the UTMB facilities

Exclusion

Currently receiving treatment for cancer
Participant has a history of epileptic seizures
Participant has a history of neurological diseases or traumatic brain injury
Participant has abnormal ear anatomy or current ear infection present
Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
Currently receiving a prescription benzodiazepine medication
Current prescription opioid dose \>50 MME/day
Current abuse of illicit drugs or alcohol (nicotine use is acceptable).
Surgery within the previous month
Report of suicide attempt or psychiatric hospitalization in the past 10 years.
Current suicidal ideation with specific plan or intent
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
Participant has 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
  • Clinical opioid withdrawal scale (COWS)day 1 and day 4

    Examination and scoring of symptoms of opioid withdrawal. score range is 1-36 with 1-2 mild, 3-24 moderate, and 25-36 severe withdrawal symptoms measured pre-treatment (day 1) and post-treatment (day4