55
Participants
Start Date
June 15, 2020
Primary Completion Date
May 25, 2021
Study Completion Date
May 25, 2021
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."
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."
Spaulding Clinical Research, West Bend
Spaulding Clinical Research LLC
OTHER
Leiden University
OTHER
Food and Drug Administration (FDA)
FED