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NCT03419858 · ClinicalTrials.gov registry record · Early Phase 1
The Role of Opioidergic Systems in Breathing Based Analgesia
A Early Phase 1 study of Pain, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03419858: Completed Early Phase 1 study of Pain, sponsored by University of California, San Diego.
NCT03419858 is a Early Phase 1 study of Pain that has completed, run by University of California, San Diego. The registered enrollment target is 60 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03419858, a Early Phase 1 study of Pain, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. We were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.
Primary Outcome
The visual analog scale (VAS) measures pain ratings that are assessed in response to noxious (49°C) thermal stimuli applied to the back of the right calf muscle. Pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher values corresponded to higher perceived pain ratings. Pain ratings were assessed at baseli
Conditions Studied
Interventions
- OTHER Saline
- DRUG Naloxone
- BEHAVIORAL Mindfulness Meditation
- BEHAVIORAL Placebo Meditation
- BEHAVIORAL Slow-Breathing
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2017-06-27 |
| Phase | Early Phase 1 |
What the finished NCT03419858 record still lists
NCT03419858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 5 interventions - of which Saline is the first listed.
NCT03419858 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03419858 about?
NCT03419858 is a clinical study titled "The Role of Opioidergic Systems in Breathing Based Analgesia". The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. We were also interested in disentanglin...
What is the current status of trial NCT03419858?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2017-03-13. Estimated completion is 2017-06-27.
What conditions does trial NCT03419858 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT03419858?
The interventions under investigation include: Saline (OTHER), Naloxone (DRUG), Mindfulness Meditation (BEHAVIORAL), Placebo Meditation (BEHAVIORAL), Slow-Breathing (BEHAVIORAL).
Who is sponsoring clinical trial NCT03419858?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03419858 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03419858's enrollment target sits among peer trials
60 224th of 374 higher than 134 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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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