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RecruitingAccepts healthy volunteersEarly Phase 1

RM1 Project 1 - tAN Naloxone

Medical University of South Carolina · NCT05490134

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
136
US sites recruiting
1
Study start
March 22, 2023
Record last updated
December 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Naloxone; Saline

Conditions: Analgesia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Bashar W Badran, PhD · badran@musc.edu

Study contacts (from the official record)

  • Bashar Badran, PhD · 8437926076 · badran@musc.edu
All healthy volunteers studies in South Carolina →
RM1 Project 1 - tAN Naloxone (NCT05490134) | Bored Studies