Using ear stimulation to treat chronic pain and opioid withdrawal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a device that stimulates nerves around the ear to alleviate chronic pain and symptoms of opioid withdrawal. Participants will reduce their opioid medication while receiving either active or sham stimulation over a two-day period in a clinical research center. The study aims to establish a neurophysiological signature of how this stimulation affects pain perception and withdrawal symptoms using functional MRI. Participants will complete questionnaires to assess their pain levels before and after the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Texas Medical Branch
  Galveston, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.