drugset / Trial / NCT05490134

RM1 Project 1 - tAN Naloxone

NCT05490134

Phase 0 Recruiting 136 enrolled Medical University of South Carolina
RandomizedFactorialQuadruple-blindTreatment

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.

Timeline

Start
2023-03-22
Primary completion
2027-01-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 0.15 mg/kg Intravenous

Indications