RM1 Project 1 - tAN Naloxone
Evaluating the Specific Role of Endogenous Opioids as the Mechanism Underlying tAN-based Analgesia in Healthy Individuals
Medical University of South Carolina
136 participants
Mar 22, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age 18-65
- Have the capacity and ability to provide one's own consent and sign the informed consent document
Exclusion Criteria14
- 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
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05490134