RM1 Project 1 - tAN Naloxone

NCT05490134 | Recruiting Early Phase 1 DMC

• 1 other identifier: Pro00122762
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Thermal Pain Thresholds

  Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.

  Change from Baseline Pain Threshold at Post-Stimulation Timepoint

Study Arms (4)

ABVN Only Stimulation

EXPERIMENTAL

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

Drug: Naloxone; Drug: Saline

ATN Only Stimulation

EXPERIMENTAL

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

Drug: Naloxone; Drug: Saline

Combination (ABVN + ATN) Stimulation

EXPERIMENTAL

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

Drug: Naloxone; Drug: Saline

Sham Stimulation

EXPERIMENTAL

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

Drug: Naloxone; Drug: Saline

Interventions

Naloxone DRUG

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.

ABVN Only Stimulation; ATN Only Stimulation; Combination (ABVN + ATN) Stimulation; Sham Stimulation

Saline DRUG

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.

Also known as: Placebo

ABVN Only Stimulation; ATN Only Stimulation; Combination (ABVN + ATN) Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Naloxone; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Bashar Badran, PhD

CONTACT

8437926076; badran@musc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will be randomized to one of four stimulation groups in a 1:1:1:1 fashion such that each group will have 34 participants. Within each group, participants will be randomized to either receive naloxone or saline on their first visit, and the opposite on their second visit. The drug visit will be counterbalanced within each group to avoid a potential order confound.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: March 22, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)