NCT05490134 is a EARLY_PHASE1 clinical trial of Naloxone in Analgesia, sponsored by Medical University of South Carolina.

Who is sponsoring NCT05490134?

NCT05490134 is sponsored by Medical University of South Carolina.

What drugs are being tested in NCT05490134?

Interventions in NCT05490134: Naloxone, Saline.

Is NCT05490134 still recruiting?

NCT05490134 is currently recruiting now. Last updated 18 December 2025.

Last reviewed 2025-12-18 · How we verify

NCT05490134

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

RM1 Project 1 - tAN Naloxone

Recruiting now EARLY_PHASE1 Last updated 18 December 2025

What this trial tests

EARLY_PHASE1 trial testing Naloxone in Analgesia in 136 participants. Currently enrolling.

Timeline

22 March 2023

Primary endpoint
1 January 2027

1 October 2027

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	136
Start date	22 March 2023
Primary completion	1 January 2027
Estimated completion	1 October 2027
Sites	1 location across United States

Drugs / interventions tested

Naloxone (NALOXONE) — full drug profile →
Saline

Conditions studied

Analgesia — all drugs for Analgesia →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 65, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Nanotechnology-Enhanced Naloxone and Alternative Treatments for Opioid Addiction.
Heyns IM, Faunce AF, Mumba MN, Kumar MNVR, et al · · 2024 · cited 2× · PMID 39144549 · DOI 10.1021/acsptsci.4c00158
The protocol for a randomized, sham-controlled trial of transcutaneous auricular neurostimulation for chronic pain and opioid withdrawal symptoms during a 4-day opioid taper for adults in the United States.
Pierson CJ, Khodaparast N, McWade MA, Kuo YF, et al · · 2025 · PMID 41102821 · DOI 10.1186/s13063-025-09171-4

Verify or expand the search:

Other trials of Naloxone

Trials testing the same drug.

NCT04975334 — Opioid Antagonism in Hypogonadotropic Hypogonadism · Phase 1 · completed
NCT05886712 — Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone) · NA · active not recruiting
NCT04975347 — Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank · Phase 1 · completed
NCT05360030 — Mechanism of Analgesic Effect on Prolonged Continuous Theta Burst Stimulation · NA · completed
NCT05142267 — Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms · NA · recruiting

Other recruiting trials for Analgesia

Currently open trials in the same condition.

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NCT07310953 — Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management · NA · recruiting
NCT06869967 — Evaluation of Postoperative Pain Control in Ear Surgery · NA · recruiting

Other Medical University of South Carolina trials

Trials by the same sponsor.

NCT06491264 — Multiparameter Optimized tES for Memory in Aging · NA · withdrawn
NCT07513389 — Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION) · Phase 2 · not yet recruiting
NCT03101917 — Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE) · NA · not yet recruiting
NCT07149207 — Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors · Phase 2 · recruiting
NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05490134 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 18 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05490134.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing