Testing a new method to relieve pain using nerve stimulation and naloxone
Evaluating the Specific Role of Endogenous Opioids as the Mechanism Underlying tAN-based Analgesia in Healthy Individuals
This study is testing a new way to relieve pain using nerve stimulation and a medication called naloxone to see if it helps people feel better without relying on opioids.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05490134 on ClinicalTrials.gov |
What this trial studies
This interventional trial involves two visits and aims to evaluate the analgesic effects of transcutaneous auricular neurostimulation (tAN) in 136 participants. It employs a randomized, double-blind, sham-controlled design to assess whether the pain relief from tAN is mediated by the release of endogenous opioids, using naloxone to block opioid receptors. Participants will receive one of four stimulation types (auricular vagus, auricular trigeminal, combination, or sham) alongside either naloxone or saline infusion to measure the effectiveness of the interventions. The study addresses the growing need for alternative pain management strategies amidst the opioid crisis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who can provide informed consent and do not have contraindications for MRI.
Not a fit: Patients with recent severe headaches, a history of substance use disorder, or those currently using pain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-opioid method for managing chronic pain, reducing reliance on prescription opioids.
How similar studies have performed: While the approach of using auricular nerve stimulation is promising, it is still relatively novel and has not been extensively tested in large-scale studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 * Have the capacity and ability to provide one's own consent and sign the informed consent document Exclusion Criteria: * Contraindicated for MRI. * Any current or recent untreated medical, neurological, or psychiatric conditions * Metal implant devices in the head, heart or neck. * History of brain surgery. * History of myocardial infarction or arrhythmia, bradycardia. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury. * Individuals suffering from frequent/severe headaches. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic. * Regular or recent pain medication use * Moderate to severe alcohol or substance use disorder. * Psychotropic or cardiac medicines that may interact with naloxone * Positive urine drug screen for opiate use * Females who are pregnant or lactating
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Bashar Badran, PhD
- Email: badran@musc.edu
- Phone: 8437926076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.