RM1 Project 1 - tAN Naloxone

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Analgesia

In brief

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.

Key facts

Study ID

NCT05490134

Run by

Medical University of South Carolina

People needed

136

Starts

2023-03-22

Expected to finish

2027-10-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• 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 is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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