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NCT05555485

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

Recruiting now NA Last updated 10 June 2025
What this trial tests

NA trial testing transcutaneous Auricular neurostimulation - Active in Opioid Withdrawal in 60 participants. Currently enrolling.

Timeline
24 May 2023
Primary endpoint
21 July 2027
30 September 2027

Quick facts

Lead sponsorThe University of Texas Medical Branch, Galveston
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date24 May 2023
Primary completion21 July 2027
Estimated completion30 September 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 18 to 65, any sex, with Opioid Withdrawal or Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The protocol for a randomized, sham-controlled trial of transcutaneous auricular neurostimulation for chronic pain and opioid withdrawal symptoms during a 4-day opioid taper for adults in the United States.
    Pierson CJ, Khodaparast N, McWade MA, Kuo YF, et al · · 2025 · PMID 41102821 · DOI 10.1186/s13063-025-09171-4

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Other recruiting trials for Opioid Withdrawal

Currently open trials in the same condition.

Other The University of Texas Medical Branch, Galveston trials

Trials by the same sponsor.

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Data sources for this page

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