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Selective Serotonin Reuptake Inhibitor
SSRIs + Opioid for Respiratory Insufficiency, Hypercapnia, and Respiratory Depression
Phase 1
Waitlist Available
Led By Jan Matousek, D.O.
Research Sponsored by Food and Drug Administration (FDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 hours on day 21
Summary
This trial tests how combining two antidepressants with a painkiller affects breathing. It involves 25 healthy participants and measures their breathing under different oxygen conditions using a special method.
Eligible Conditions
- Respiratory Depression
- Hypercapnia
- Chronic Respiratory Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 hours on day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 hours on day 21
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Minute ventilation at 55mm Hg end tidal CO2 (VE55) under hyperoxic conditions on day 21
VE55 under hyperoxic conditions on day 20
Secondary study objectives
VE55 under hyperoxic conditions on day 11
VE55 under hyperoxic conditions on day 12
VE55 under hyperoxic conditions on day 5
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment C: EscitalopramExperimental Treatment1 Intervention
Participants will receive escitalopram on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Group II: Treatment B: ParoxetineExperimental Treatment1 Intervention
Participants will receive paroxetine on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Group III: Treatment A: PlaceboPlacebo Group1 Intervention
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paroxetine and Oxycodone
2022
Completed Phase 1
~30
Escitalopram and Oxycodone
2022
Completed Phase 1
~30
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Food and Drug Administration (FDA)Lead Sponsor
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Spaulding Clinical Research LLCOTHER
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Leiden UniversityOTHER
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Jan Matousek, D.O.Principal InvestigatorSpaulding Clinical Research LLC
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7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment C: Escitalopram
- Group 2: Treatment B: Paroxetine
- Group 3: Treatment A: Placebo
Timeline:
This trial has the following timeline:- 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.
Awards:
This trial has 0 awards, including: