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NCT04034004 · ClinicalTrials.gov registry record · Early Phase 1
Chronic Low Back Pain and Meditation
A Early Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 88
- Enrollment target
NCT04034004: Completed Early Phase 1 study, sponsored by University of California, San Diego.
NCT04034004 is a Early Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 88 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04034004, a Early Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.
Primary Outcome
Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.
Interventions
- OTHER Saline
- DRUG Naloxone
- BEHAVIORAL Mindfulness
- BEHAVIORAL Meditation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2022-12-22 |
| Phase | Early Phase 1 |
What the finished NCT04034004 record still lists
NCT04034004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT04034004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04034004 about?
NCT04034004 is a clinical study titled "Chronic Low Back Pain and Meditation". The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist ...
What is the current status of trial NCT04034004?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 88 participants. The study started on 2021-01-01. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT04034004?
The interventions under investigation include: Saline (OTHER), Naloxone (DRUG), Mindfulness (BEHAVIORAL), Meditation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04034004?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04034004's enrollment target sits among peer trials
88 249th of 2000 higher than 1,751 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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