Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

May 25, 2021

Study Completion Date

May 25, 2021

Conditions
HypercapniaVentilatory Depression
Interventions
DRUG

Oxycodone and Midazolam

"In one period subjects receive oxycodone 10-15 mg immediate release (IR) and placebo IV 1x per day.~In a second period (randomized cross-over), subjects receive midazolam 0.0375-0.075 mg/kg IV and oral placebo tablet 1x per day.~In a third period (randomized cross-over), subjects receive oxycodone 10-15 mg IR tablet and 0.0375-0.075 mg/kg midazolam IV 1x per day.~In a fourth period (randomized cross-over), subjects receive oral placebo tablet and placebo IV 1x per day."

DRUG

Oxycodone, Paroxetine, and Quetiapine

"In one period, subjects receive: oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.~In a second period (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.~In a third period (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5."

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

NCT04310579 - Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation | Biotech Hunter | Biotech Hunter