Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01595867
First received: May 8, 2012
Last updated: June 7, 2012
Last verified: June 2012

May 8, 2012
June 7, 2012
August 2010
January 2011   (final data collection date for primary outcome measure)
  • Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01595867 on ClinicalTrials.gov Archive Site
  • Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter minimum peak effect (Emin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter time to minimum peak effect (TEmin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Drug Liking Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • High Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Feel Sick Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Nausea Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sleepy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Dizzy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter minimum peak effect (Emin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter time to minimum peak effect (TEmin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol - Time to maximum observed plasma concentration (Tmax [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma 6-�-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Narcotic Abuse
  • Opioid-related Disorders
  • Analgesia
  • Chronic Pain
  • Drug: Placebo
    Lactose (100 mg) placebo tablets crushed; single dose
  • Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride
    EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
  • Drug: morphine sulfate CR crushed.
    Morphine sulfate controlled release 30 mg tablet crushed
  • Placebo Comparator: Treatment A
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    EMBEDA 30 mg crushed
    Intervention: Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride
  • Active Comparator: Treatment C
    Morphine Sulfate Controlled Release 30 mg crushed
    Intervention: Drug: morphine sulfate CR crushed.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects 18 to 55 years of age, inclusive.
  • Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
  • Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
  • Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
  • Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
  • Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
  • History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
  • History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01595867
ALO-01-10-4004, B4541005
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP