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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 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05470465
The ClinicalTrials.gov registry entry for NCT05470465 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo and Oxycodone is the first listed.
NCT05470465 reports 0 study locations.
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.
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