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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01380093
First received: June 22, 2011
Last updated: April 26, 2012
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Nondependent Opioid Abuse, Episodic
 Drug: Placebo
Drug: MS Contin (morphine sulfate, controlled release)
Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.5, 1, 1.5 and 2 hrs post-dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.5 and 1 hrs post-dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 - ∞).


Enrollment: 80
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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
Active Comparator: MS Contin (morphine sulfate, controlled release) 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
Experimental: EMBEDA (morphine sulfate / naltrexone hydrochloride) 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380093

Locations
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01380093     History of Changes
Other Study ID Numbers: ALO-01-10-4005, B4541003
Study First Received: June 22, 2011
Results First Received: April 26, 2012
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
abuse potential
abuse liability
recreational opioid use
morphine

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Naltrexone
Morphine
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013