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Trial record 1 of 1 for:    NCT01380093
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Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users

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ClinicalTrials.gov Identifier: NCT01380093
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : May 31, 2012
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 22, 2011
First Posted Date  ICMJE June 27, 2011
Results First Submitted Date  ICMJE April 26, 2012
Results First Posted Date  ICMJE May 31, 2012
Last Update Posted Date May 31, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    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 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).
  • Drug Liking: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.
  • High: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • High: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • VAS - Drug Liking - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - High - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    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 bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.
  • High: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • High: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • High: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • High: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • High: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Good Effects: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Good Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Any Effects: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Any Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Bad Effects: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Bad Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: Pre-dose, 0.5 and 1 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Nausea: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Nausea: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Nausea: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Nausea: Peak Effect (Emax) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Feel Sick: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Sleepy: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Dizzy: Peak Effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Overall Drug Liking Effect at 24 Hours [ Time Frame: 24 hrs post dose ]
    Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").
  • Take Drug Again Effect at 24 Hours [ Time Frame: 24 hrs post dose ]
    Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: Pre-dose, 0.5 and 1 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
  • Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
  • Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
  • Pupillometry: Peak Effect (Emax) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine [ Time Frame: Pre-dose, 0.5 and 1 hrs post-dose ]
    AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose ]
    AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone [ Time Frame: Pre-dose, 0.5 and 1 hrs post-dose ]
    AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose ]
    AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5 and 1 hrs post-dose ]
    AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose ]
    AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose ]
    AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose ]
    AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose ]
    AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose ]
    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Drug Liking - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Drug Liking - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - High - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - High - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Any Drug Effects - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Any Drug Effects - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Good Effects - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Good Effects - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Bad Effects - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Bad Effects - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Bad Effects - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Feel Sick - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Feel Sick - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Nausea - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hr post dose ]
  • VAS - Nausea - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hr post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Sleepy - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Sleepy - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Sleepy - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • VAS - Dizzy - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • VAS - Dizzy - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Dizzy - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-1h) [ Time Frame: 0-1 hr post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-2h) [ Time Frame: 0-2 hrs post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-4h) [ Time Frame: 0-4 hrs post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-8h) [ Time Frame: 0-8 hrs post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-12h) [ Time Frame: 0-12 hrs post dose ]
  • Pupillometry - Area Under Effect Curve (AUE 0-24h) [ Time Frame: 0-24 hrs post dose ]
  • Pupillometry - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • Pupillometry - Time of Peak Effect (TEmax) [ Time Frame: up to 24 hrs post dose ]
  • Overall Drug Liking - Effect at 24h [ Time Frame: 24 hrs post dose ]
  • Take Drug Again - Effect at 24h [ Time Frame: 24 hrs post dose ]
  • Morphine Cmax [ Time Frame: up to 24 hrs post dose ]
  • Morphine Tmax [ Time Frame: up to 24 hrs post dose ]
  • Morphine AUC (0-1h) [ Time Frame: 0-1 hr post dose ]
  • Morphine AUC (0-2h) [ Time Frame: 0-2 hrs post dose ]
  • Morphine AUC (0-4h) [ Time Frame: 0-4 hrs post dose ]
  • Morphine AUC (0-8h) [ Time Frame: 0-8 hrs post dose ]
  • Morphine AUC (0-12h) [ Time Frame: 0-12 hrs post dose ]
  • Morphine AUC (0-24h) [ Time Frame: 0-24 hrs post dose ]
  • Morphine AUC (0-inf) [ Time Frame: 0-inf post dose ]
  • Naltrexone Cmax [ Time Frame: up to 24 hrs post dose ]
  • Naltrexone Tmax [ Time Frame: up to 24 hrs post dose ]
  • Naltrexone AUC (0-2h) [ Time Frame: 0-2 hrs post dose ]
  • Naltrexone AUC (0-4h) [ Time Frame: 0-4 hrs post dose ]
  • Naltrexone AUC (0-8h) [ Time Frame: 0-8 hrs post dose ]
  • Naltrexone AUC (0-12h) [ Time Frame: 0-12 hrs post dose ]
  • Naltrexone AUC (0-24h) [ Time Frame: 0-24 hrs post dose ]
  • Naltrexone AUC (0-inf) [ Time Frame: 0-inf post dose ]
  • 6-β-naltrexol Cmax [ Time Frame: up to 24 hrs post dose ]
  • 6-β-naltrexol Tmax [ Time Frame: up to 24 hrs post dose ]
  • 6-β-naltrexol AUC (0-1h) [ Time Frame: 0-1 hr post dose ]
  • 6-β-naltrexol AUC (0-2h) [ Time Frame: 0-2 hrs post dose ]
  • 6-β-naltrexol AUC (0-4h) [ Time Frame: 0-4 hrs post dose ]
  • 6-β-naltrexol AUC (0-8h) [ Time Frame: 0-8 hrs post dose ]
  • 6-β-naltrexol AUC (0-12h) [ Time Frame: 0-12 hrs post dose ]
  • 6-β-naltrexol AUC (0-24h) [ Time Frame: 0-24 hrs post dose ]
  • 6-β-naltrexol AUC (0-inf) [ Time Frame: 0-inf post dose ]
  • VAS - Good Effects - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Feel Sick - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • VAS - Nausea - Peak Effect (Emax) [ Time Frame: up to 24 hrs post dose ]
  • Naltrexone AUC (0-1h) [ Time Frame: 0-1 hr post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Official Title  ICMJE A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users
Brief Summary The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Nondependent Opioid Abuse, Episodic
Intervention  ICMJE
  • Drug: Placebo
    Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
  • Drug: MS Contin (morphine sulfate, controlled release)
    Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
  • Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)
    Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: MS Contin (morphine sulfate, controlled release)
    Intervention: Drug: MS Contin (morphine sulfate, controlled release)
  • Experimental: EMBEDA (morphine sulfate / naltrexone hydrochloride)
    Intervention: Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)
Publications * Setnik B, Sommerville K, Goli V, Han L, Webster L. Assessment of pharmacodynamic effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013 Aug;14(8):1173-86. doi: 10.1111/pme.12148. Epub 2013 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
80
Original Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
36
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a recreational opioid user who is NOT physically 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 recreationally abusing 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 prior to Visit 1.
  • Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • Has a history or current diagnosis of substance 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).
  • History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
  • 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).
  • Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380093
Other Study ID Numbers  ICMJE ALO-01-10-4005
B4541003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2011

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