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NCT05555485
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
NA trial testing transcutaneous Auricular neurostimulation - Active in Opioid Withdrawal in 60 participants. Currently enrolling.
21 July 2027
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 May 2023 |
| Primary completion | 21 July 2027 |
| Estimated completion | 30 September 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- transcutaneous Auricular neurostimulation - Active
- transcutaneous auricular neurostimulation - Sham
Conditions studied
- Opioid Withdrawal — all drugs for Opioid Withdrawal →
- Analgesia — all drugs for Analgesia →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05555485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05555485 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 10 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05555485.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing