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NCT03066739 · ClinicalTrials.gov registry record · Phase 2
Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
A Phase 2 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03066739: Clinical Trial Phase 2 study, sponsored by University of California, Irvine.
NCT03066739 is a Phase 2 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03066739, a Phase 2 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery. There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone). The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low score in mechanical pain threshold) in the HN group will be lower than in the HI group.
Primary Outcome
Mechanical Pain Threshold-determined by von Frey filaments around the incision site. The force required to elicit a pain response was recorded in grams. Higher values indicate higher pain thresholds (i.e., less hyperalgesia), while lower values indicate greater pain sensitivity.
Interventions
- DRUG Remifentanil
- DRUG Remifentanil+ Placebo
- DRUG Remifentanil +ultra-low dose naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-02-25 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 2 |
Why NCT03066739 stopped before completion
NCT03066739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Remifentanil is the first listed.
NCT03066739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03066739 about?
NCT03066739 is a clinical study titled "Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia". The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery. There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifenta...
What is the current status of trial NCT03066739?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-02-25. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT03066739?
The interventions under investigation include: Remifentanil (DRUG), Remifentanil+ Placebo (DRUG), Remifentanil +ultra-low dose naloxone (DRUG).
Who is sponsoring clinical trial NCT03066739?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03066739's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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