RM1 Project 1 - tAN Naloxone

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Naloxone

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