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NCT05490134 · ClinicalTrials.gov registry record · Early Phase 1
RM1 Project 1 - tAN Naloxone
A Early Phase 1 study of Analgesia, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 136
- Enrollment target
- 1
- Study location
NCT05490134: Recruiting Early Phase 1 study of Analgesia, sponsored by Medical University of South Carolina.
NCT05490134 is a Early Phase 1 study of Analgesia that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 136 participants, above the 86-participant average among 19 other Analgesia trials with a reported enrollment target (58% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05490134, a Early Phase 1 study of Analgesia, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 136 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Saline
- DRUG Naloxone
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2027-10-01 |
| Phase | Early Phase 1 |
What NCT05490134 shows while recruiting
NCT05490134 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 19 other Analgesia trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Analgesia appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT05490134 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05490134 about?
NCT05490134 is a clinical study titled "RM1 Project 1 - tAN Naloxone". 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. Analge...
What is the current status of trial NCT05490134?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 136 participants. The study started on 2023-03-22. Estimated completion is 2027-10-01.
What conditions does trial NCT05490134 study?
This clinical trial studies the following conditions: Analgesia.
What interventions are being tested in trial NCT05490134?
The interventions under investigation include: Saline (DRUG), Naloxone (DRUG).
Who is sponsoring clinical trial NCT05490134?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05490134 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Analgesia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05490134's enrollment target sits among peer trials
136 3rd of 19 higher than 17 of 19 other Analgesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Analgesia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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