Actively Recruiting
RM1 Project 1 - tAN Naloxone
Led by Medical University of South Carolina · Updated on 2025-12-18
136
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
RM1 Project 1 - tAN Naloxone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65
- Ability to provide informed consent and sign consent document
You will not qualify if you...
- Contraindicated for MRI
- Current or recent untreated medical, neurological, or psychiatric conditions
- Metal implants in head, heart, or neck
- History of brain surgery
- History of heart attack, arrhythmia, or bradycardia
- Personal or family history of seizure or epilepsy or use of medications lowering seizure threshold
- History of head injury, concussion, or moderate to severe traumatic brain injury
- Frequent or severe headaches
- History or current psychosis or mania
- Regular or recent use of pain medication
- Moderate to severe alcohol or substance use disorder
- Use of psychotropic or cardiac medications that may interact with naloxone
- Positive urine drug screen for opiates
- Pregnant or lactating females
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
B
Bashar Badran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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