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SSRIs + Opioid for Respiratory Insufficiency, Hypercapnia, and Respiratory Depression
Study Summary
This trial is designed to study the effects of combining the drugs paroxetine or escitalopram with an opioid on ventilation.
- Respiratory Depression
- Hypercapnia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- Your doctor determined that you have a difficult airway based on the way your mouth and throat look.You have had thoughts of hurting yourself or have tried to hurt yourself in the past.You have known or suspected allergies or sensitivities to any of the medications used in the study.You have taken opioid or psychotropic drugs in the past two months before the study starts.You have a damaged eye or surrounding tissues, such as a misshapen pupil, swollen tissue, or an open wound.You have a history of sleep problems or mental health conditions like panic disorder or anxiety disorder.You have a condition called hypoventilation syndrome or sleep apnea and use a breathing device to help you breathe while sleeping.You have a skin condition that may make it difficult to place the ECG electrodes properly.
- Group 1: Treatment A: Placebo
- Group 2: Treatment B: Paroxetine
- Group 3: Treatment C: Escitalopram
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any documented risk associated with concurrent use of Paroxetine and Oxycodone?
"Paroxetine and Oxycodone being tested in this Phase 1 trial are believed to be of low risk, resulting in a score of 1. As such, there is only limited evidence supporting their safety or efficacy."
How many individuals are engaging in this research effort?
"Affirmative. Clinicaltrials.gov details that this medical trial, which was initially shared on September 1st 2022, is actively recruiting participants. 25 people need to be recruited from a single location."
Is there still an opportunity to enroll for this clinical trial?
"Clinicaltrials.gov shows that this research trial is actively searching for participants, having been first listed on September 1st 2022 and recently modified on October 19th of the same year."
What is the primary aim of this clinical experiment?
"The goal of this medical study is to measure the Minute ventilation at 55mm Hg end tidal CO2 (VE55) under hyperoxic conditions on day 21 over a 5 hour period. Secondary outcomes include VE55 values for days 11 and 5, as well comparing escitalopram or paroxetine with oxycodone against oxycodone alone on day 12. Regression analysis will be conducted between minute ventilation levels and partial pressure of end tidal CO2 (PETCO2), followed by comparison using linear mixed effects model - all occuring within a five-hour window on each designated date."
Is the age restriction for this clinical trial limited to those who are over thirty years old?
"This clinical trial is only available for individuals aged between 18 and 50, as 31 studies are being conducted on those younger than 18, while 164 trials focus on people over 65."
Might I be eligible to participate in this clinical investigation?
"The clinical trial is inviting 25 persons aged 18-50 with hypercapnia who meet the following criteria to apply: Institutional Review Board (IRB) approved written informed consent, non-smoking status and body mass index of 18.5 - 33.0 kg/m2, standard medical history findings & laboratory results, negative test result for alcohol or drugs of abuse at screening & check-in days, SARS-CoV-2 rapid antigen testing at check-in; female participants must be non childbearing potential confirmed by a follicle stimulating hormone level > 40 mIU/mL or practice two highly effective methods of birth control"
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