Recruiting

Early Phase 1

tAN NaloxoneRM1 Project 1 - tAN Naloxone

Sponsor:

Medical University of South Carolina

Code:

NCT05490134

Conditions

Analgesia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Naloxone

Saline

Study Details

Brief 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

Study ID

NCT05490134

Start date

Mar 22, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Age 18-65
Have the capacity and ability to provide one's own consent and sign the informed consent document

Exclusion Criteria:

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

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABVN Only Stimulation

30 minutes of ABVN Only stimulation (15Hz stimulation of cymba conchae).

experimental: ATN Only Stimulation

30 minutes of ATNS Only stimulation (100Hz stimulation adjacently anterior to the tragus)

experimental: Combination (ABVN + ATN) Stimulation

30 minutes of Combo stimulation (stimulation of both the 15Hz cymba conchae and 100HZ adjacently anterior to the tragus)

experimental: Sham Stimulation

30 minutes of Sham (15Hz stimulation of the earlobe)

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.

Primary outcome measure

Thermal Pain Thresholds [ Time Frame: Change from Baseline Pain Threshold at Post-Stimulation Timepoint ]

Central Contacts and Locations

Central contacts

Bashar Badran, PhD

8437926076 badran@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Bashar W Badran, PhD

badran@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-18.