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NCT03801629 · ClinicalTrials.gov registry record · Phase 1
Neuroimmune Effects of Opioid Administration
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03801629: Completed Phase 1 study, sponsored by Yale University.
NCT03801629 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801629, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Preclinical research indicates acute opioid administration evokes an immune response in the periphery and brain. Here, we will translate those preclinical findings to healthy human volunteers and quantify the neuroimmune response to a morphine challenge using positron emission tomography (PET) imaging with \[11C\]PBR28.
Primary Outcome
Relative to pre-morphine levels, we will measure the change in brain regional TSPO availability (VT) after morphine. VT will be calculated for brain regions of interest using multi-linear analysis 1 (t\*=30) using the metabolite-corrected arterial input function.
Interventions
- DRUG High Morphine Dose
- DRUG Low Morphine Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 1 |
What the finished NCT03801629 record still lists
NCT03801629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which High Morphine Dose is the first listed.
NCT03801629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801629 about?
NCT03801629 is a clinical study titled "Neuroimmune Effects of Opioid Administration". Preclinical research indicates acute opioid administration evokes an immune response in the periphery and brain. Here, we will translate those preclinical findings to healthy human volunteers and quantify the neuroimmune response to a morphine challenge using positron emission tomography (PET) imagi...
What is the current status of trial NCT03801629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-09-12. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT03801629?
The interventions under investigation include: High Morphine Dose (DRUG), Low Morphine Dose (DRUG).
Who is sponsoring clinical trial NCT03801629?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03801629's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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