Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) & an Opioid on

Status Completed

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

Clinical Trial Details

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

View Details

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	`NCT01898858` - Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic	N/A
Completed	`NCT02068274` - CO2 Monitoring Study	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms