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NCT05470465 · ClinicalTrials.gov registry record · Phase 1
Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT05470465: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT05470465 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05470465, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effects of the coadministration of paroxetine or escitalopram with an opioid on ventilation. Ventilation will be assessed using a rebreathing methodology. This study will evaluate chronic and acute dosing of paroxetine and escitalopram combined with an opioid as well as chronic and acute dosing of the two drugs without coadministration of an opioid. This study is a 3-period, randomized, placebo-controlled crossover study conducted with 25 healthy participants. Each participant will receive each of the 3 treatments (placebo/oxycodone, paroxetine/oxycodone, escitalopram/oxycodone) in a randomized order.
Primary Outcome
Comparison of escitalopram or paroxetine with oxycodone to oxycodone alone. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 21.
Interventions
- DRUG Placebo and Oxycodone
- DRUG Paroxetine and Oxycodone
- DRUG Escitalopram and Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2023-09-17 |
| Phase | Phase 1 |
What the finished NCT05470465 record still lists
NCT05470465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo and Oxycodone is the first listed.
NCT05470465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05470465 about?
NCT05470465 is a clinical study titled "Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation". This study is designed to evaluate the effects of the coadministration of paroxetine or escitalopram with an opioid on ventilation. Ventilation will be assessed using a rebreathing methodology. This study will evaluate chronic and acute dosing of paroxetine and escitalopram combined with an opioid a...
What is the current status of trial NCT05470465?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-09-01. Estimated completion is 2023-09-17.
What interventions are being tested in trial NCT05470465?
The interventions under investigation include: Placebo and Oxycodone (DRUG), Paroxetine and Oxycodone (DRUG), Escitalopram and Oxycodone (DRUG).
Who is sponsoring clinical trial NCT05470465?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05470465's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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