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RecruitingAnalgesia

RM1 Project 1 - tAN Naloxone

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

This two-visit, randomized, double-blind, sham-controlled trial, uses a novel naloxone blockade model in 136 individuals to determine whether the analgesic effects of a 30-minute transcutaneous auricular neurostimulation (tAN) intervention are mediated through a release of endogenous opioids. Analgesic effects of four various stimulation interventions will be measured (auricular vagus, auricular trigeminal, combination, or sham) while varying the type of intravenous (IV) infusion (either naloxone or saline) a participant is administered to determine whether the analgesic effects are mitigated by pharmacological opioid receptor blockade.

Sponsor: Medical University of South Carolina

You may qualify if…

  • Age 18-65
  • Have the capacity and ability to provide one's own consent and sign the informed consent document

You may not qualify if…

  • 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.

Where it's recruiting

South Carolina

Charleston

Source: ClinicalTrials.gov · NCT05490134 · last updated 2025-12-18