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A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Administered Orally Whole And/or Chewed To Non-dependent, Recreational Opioid Users Under Fasted Conditions
This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.
Details
| Lead sponsor | Pain Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 67 |
| Start date | 2013-11 |
| Completion | 2014-08 |
Conditions
- Opioid Users
Interventions
- Capsule
- PF-00345439
- PF-00345439
- oxycodone
Primary outcomes
- Drug Liking: Peak Effect (Emax) — 12 hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely. - High: Peak Effect (Emax) — 12 hours
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely. - Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours — 2 hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely. - High: Area Under Effect Curve (AUE) From 0-2 Hours — 2 hours
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.
Countries
United States