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

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

September 17, 2023

Study Completion Date

September 17, 2023

Conditions
HypercapniaVentilatory Depression
Interventions
DRUG

Placebo and Oxycodone

Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.

DRUG

Paroxetine and Oxycodone

Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.

DRUG

Escitalopram and Oxycodone

Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

collaborator

Leiden University

OTHER

lead

Food and Drug Administration (FDA)

FED