Paroxetine and Oxycodone for Respiratory Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Respiratory Depression+1 MoreParoxetine and Oxycodone - Drug
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the effects of combining the drugs paroxetine or escitalopram with an opioid on ventilation.

Eligible Conditions
  • Respiratory Depression
  • Hypercapnia

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 5 hours on day 21

Day 11
VE55 under hyperoxic conditions on day 11
Day 12
VE55 under hyperoxic conditions on day 12
Day 20
VE55 under hyperoxic conditions on day 20
Day 21
Minute ventilation at 55mm Hg end tidal CO2 (VE55) under hyperoxic conditions on day 21
Day 5
VE55 under hyperoxic conditions on day 5
Day 6
Hyperoxia

Trial Safety

Trial Design

3 Treatment Groups

Treatment B: Paroxetine
1 of 3
Treatment C: Escitalopram
1 of 3
Treatment A: Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

25 Total Participants · 3 Treatment Groups

Primary Treatment: Paroxetine and Oxycodone · Has Placebo Group · Phase 1

Treatment B: Paroxetine
Drug
Experimental Group · 1 Intervention: Paroxetine and Oxycodone · Intervention Types: Drug
Treatment C: Escitalopram
Drug
Experimental Group · 1 Intervention: Escitalopram and Oxycodone · Intervention Types: Drug
Treatment A: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo and Oxycodone · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 hours on day 21

Who is running the clinical trial?

Food and Drug Administration (FDA)Lead Sponsor
152 Previous Clinical Trials
953,786 Total Patients Enrolled
Spaulding Clinical Research LLCOTHER
20 Previous Clinical Trials
989 Total Patients Enrolled
Leiden UniversityOTHER
27 Previous Clinical Trials
11,103 Total Patients Enrolled
Jan Matousek, D.O.Principal InvestigatorSpaulding Clinical Research LLC
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a healthy, non-smoking man or woman, 18 to 50 years of age, inclusive, who has a body mass index of 18.5 to 33.0 kg/m2, inclusive, at Screening.
You have a negative test result for alcohol and drugs of abuse at screening and check-in days.
Subjects are required to comply with the protocol defined by the investigator.
References