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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05490134
The ClinicalTrials.gov registry entry for NCT05490134 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 19 other Analgesia trials with a reported enrollment target (58% higher). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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