Testing a new method to relieve pain using nerve stimulation and naloxone

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Bashar Badran, PhD
• Email: badran@musc.edu
• Phone: 8437926076

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anterior Knee Nerves Block vs Femoral Nerve Block for Knee Arthroscopy

  This trial tests whether an anterior nerves of the knee (ANK) block provides similar pain relief to a femoral nerve block after knee arthroscopy in adults, aiming to reduce quadriceps weakness.

  Recruiting Van Training and Research Hospital · Van · NCT07910500

• Esmolol vs Dexmedetomidine for opioid-sparing in laparoscopic gynecologic surgery

  This study tests whether low-dose esmolol or dexmedetomidine, given during surgery, reduces opioid use and improves pain control after laparoscopic hysterectomy compared with placebo.

  Recruiting National and Kapodistrian University of Athens · Athens · NCT07846722

• Three nerve blocks for knee replacement: which one works best

  This trial tests three different nerve blocks used during knee replacement to see which provides the best pain relief for patients after surgery.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Italy and 1 other locations · NCT07751653

• Rectointercostal plane block to reduce pain after laparoscopic gallbladder removal

  This study tests whether giving a rectointercostal block during laparoscopic cholecystectomy can lower postoperative pain for patients without changing general anesthesia.

  Recruiting Istinye University · Istanbul · NCT07745972

• STIL block versus RIB with sub-serratus plane block for pain relief after pediatric chest surgery

  This study tests whether the STIL plane block provides comparable or better pain relief than the combination of RIB and sub-serratus plane block in children after thoracotomy.

  Recruiting Tanta University · Tanta, El-Gharbia · NCT07666334

• SPSIP Block to Help Pain After Breast Reduction Surgery

  A randomized trial tests whether adding an ultrasound-guided SPSIP block can lower opioid use in the first 24 hours after bilateral breast reduction surgery.

  Recruiting Cumhuriyet University Hospital · Sivas, Sivas · NCT07657949

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.