Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This study is designed to evaluate the effects of the coadministration of paroxetine or escitalopram, two selective serotonin reuptake inhibitors (SSRI), with an opioid on hypercapnic ventilation. Hypercapnic ventilation will be assessed under both hyperoxic and hypoxic conditions using the Duffin rebreathing method. This method allows for critical physiological measurements and thresholds to be captured that can then be used to model the effects of drugs when there are dynamic changes in oxygen partial pressure (PO2) and carbon dioxide partial pressure (PCO2), such as during a real-world opioid overdose. SSRIs take approximately 3 weeks to reach maximal therapeutic effect, which correlates with the time required for pre-synaptic inhibitory serotonergic receptors to desensitize. Therefore, drug-effects on ventilation should be evaluated under steady state conditions. This study is randomized, placebo-controlled crossover study which includes three 21-day periods conducted with 25 healthy participants. Participants will receive each of the 3 treatments (placebo/oxycodone, paroxetine/oxycodone, or escitalopram/oxycodone) in a randomized order. Paroxetine dosing will range from 40-60 mg once daily (QD) and escitalopram dosing will range from 20-30 mg QD. Subjects will receive 10 mg oxycodone on three different days each period. Subjects will undergo 6 days of rebreathing and time-matched pupillary assessments along with 3 separate days of ECG assessments each period. Additionally, blood samples will be collected for determination of plasma concentrations for each study drug on days with rebreathing and ECG assessments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05470465
Study type Interventional
Source Food and Drug Administration (FDA)
Contact
Status Completed
Phase Phase 1
Start date September 1, 2022
Completion date September 17, 2023

See also
  Status Clinical Trial Phase
Terminated NCT02801162 - Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard N/A
Completed NCT02917668 - Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Cardiac Surgery Patients N/A
Completed NCT02429154 - Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO) N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT02068274 - CO2 Monitoring Study N/A
Completed NCT01898858 - Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic N/A
Completed NCT00006318 - Role of Prostaglandins in the Regulation of Brain Blood Flow N/A
Completed NCT00001845 - Study of Brain Blood Flow During Induced Hypercapnia (Excess Blood Carbon Dioxide) N/A
Completed NCT05116397 - Influence of Graded Hypercapnia on Endurance Exercise Performance N/A
Completed NCT03221387 - Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients N/A
Recruiting NCT05505279 - Ventilatory Effects of THRIVE During EBUS Phase 3
Completed NCT04497090 - Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation N/A
Completed NCT01882257 - Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury N/A
Terminated NCT00710541 - Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD) N/A
Completed NCT05189158 - Ventilatory Responses to Hypercapnic and Hypoxic Conditions in Hyperventilants N/A
Completed NCT04409470 - Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients
Completed NCT04512781 - Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs N/A
Recruiting NCT03741998 - Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange N/A
Recruiting NCT05761756 - Oxygen Toxicity: Mechanisms in Humans N/A
Recruiting NCT02980770 - Postoperative Complications in Patients With Obesity Hypoventilation Syndrome N/A