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RM1 Project 1 - tAN Naloxone
Sponsor: Medical University of South Carolina
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.
Official title: Evaluating the Specific Role of Endogenous Opioids as the Mechanism Underlying tAN-based Analgesia in Healthy Individuals
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2023-03-22
Completion Date
2027-10-01
Last Updated
2025-12-18
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Medical University of South Carolina
Charleston, South Carolina, United States