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RM1 Project 1 - tAN Naloxone

NCT05490134 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Analgesia

Interventions

DRUG

Naloxone

A 0.15 mg/kg bolus dose of naloxone in 10ml normal saline will be administered via an intravenous (IV) line inserted into the antecubital vein of the non-dominant arm.

DRUG

Saline

0.15mg/kg bolus of normal saline in 10ml normal saline will be administered via an intravenous (IV) line inserted into the antecubital vein of the non-dominant arm.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490134 on ClinicalTrials.gov