Developed by Shray Alag, The Harker School
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Clinical Trials, and HPO
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There is one clinical trial.
Opioids can decrease breathing and co-administration of benzodiazepines with opioids can further decrease breathing. It is unknown whether certain other drugs also decrease breathing when co-administered with opioids. The objective of this study is to determine whether certain drugs combined with an opioid decrease breathing compared to breathing with an opioid alone. In order to assess this, this study will utilize the Read Rebreathing method, where study participants breathe increased levels of oxygen and carbon dioxide. The increased levels of carbon dioxide cause the study participants to increase breathing. This increased breathing response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using this procedure, low doses of opioids or benzodiazepines can be administered that have minimal-to-no effects on breathing when study participants are going about normal activities breathing room air, however breathing increases less than expected as carbon dioxide levels are increased. This study will also obtain quantitative pupillometry measurements before and after each rebreathing assessment to allow for comparisons of pupillary changes to ventilatory changes when subjects receive different drugs and drug combinations. This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1 and Part 2). The Lead-In Reproducibility Phase will measure the variability between study participants and between repeated uses of the method in the same study participant within a day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their combination to show the methodology will detect changes in breathing at low doses of the drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due to their effects on breathing in a nonclinical model, decrease the breathing response when combined with an opioid compared to when an opioid is administered alone.
Description: Data will be analyzed using nonlinear regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data and used to estimate VE55.
Measure: Part 1 - Comparison of the minute ventilation at the 55 mm Hg end tidal carbon dioxide (CO2) point (VE55) of midazolam combined with oxycodone vs. oxycodone alone. Time: Part 1: 2 hour timepoint on Day 1Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.
Measure: Part 2 - Comparison of the minute ventilation at the 55 mm Hg end tidal CO2 point (VE55) of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 1. Time: Part 2: 5 hour timepoint on Day 1Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.
Measure: Part 2 - Comparison of the minute ventilation at the 55 mm Hg end tidal CO2 point (VE55) of paroxetine or quetiapine combined with oxycodone vs. oxycodone alone on Day 5. Time: Part 2: 5 hour timepoint on Day 5Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.
Measure: Part 1 - VE55 of oxycodone or midazolam alone compared to placebo Time: Part 1: 2 hour timepoint on Day 1Description: Data will be analyzed using nonlinear regression of the minute ventilation versus PETCO2 data and used to estimate VE55.
Measure: Part 2 - VE55 of paroxetine or quetiapine alone compared to placebo Time: Part 2: 5 hour timepoint on Day 4Description: Cmax will be summarized using descriptive statistics
Measure: Part 1 - Maximum observed plasma concentration (Cmax) of oxycodone alone vs. in combination with midazolam Time: Part 1: Day 1 at 0, 1, 2, 3, 4, 6, 8, 12, 24 hourDescription: Cmax will be summarized using descriptive statistics
Measure: Part 2 - Cmax of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 1 Time: Part 2: Day 1 at 3, 4, 5, 6, 9, 12, 24 hourDescription: Cmax will be summarized using descriptive statistics
Measure: Part 2 - Cmax of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 5 Time: Part 2: Day 5 at 3, 4, 5, 6, 9, 12, 24 hourDescription: AUC will be summarized using descriptive statistics
Measure: Part 1 - Area under the plasma concentration-time curve (AUC) of oxycodone alone vs. in combination with midazolam Time: Part 1: Day 1Description: AUC will be summarized using descriptive statistics
Measure: Part 2 - AUC of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 1 Time: Part 2: Day 1Description: AUC will be summarized using descriptive statistics
Measure: Part 2 - AUC of oxycodone alone vs. in combination with paroxetine or quetiapine on Day 5 Time: Part 2: Day 5Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports