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Trial record 1 of 1 for:    NCT01775189
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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

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ClinicalTrials.gov Identifier: NCT01775189
Recruitment Status : Completed
First Posted : January 24, 2013
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 24, 2013
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE July 17, 2017
Last Update Posted Date July 17, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • Drug Liking: Peak Effect (Emax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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 VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours 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 VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
  • High: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • High: Area Under Effect Curve (AUE) From 0-2 Hour [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from '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 hours.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • High: Area Under Effect Curve (AUE) From 0-2 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • High: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Drug Liking: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
Change History Complete list of historical versions of study NCT01775189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • Take Drug Again: Peak Effect (Emax) [ Time Frame: Intervention period: 12, 24 hours 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"). Emax = Maximum observed score.
  • Take Drug Again: Mean Effect (Emean) [ Time Frame: Intervention period: 12, 24 hours 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"). Emean = Average observed score.
  • Take Drug Again Effect at Hours 12 and 24 [ Time Frame: Intervention period: 12, 24 hours 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").
  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: Intervention period: 12, 24 hours 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 carry-over 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"). Emax = Maximum observed score.
  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: Intervention period: 12, 24 hours 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 carry-over 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"). Emean = Average observed score.
  • Overall Drug Liking Effect at Hours 12 and 24 [ Time Frame: Intervention period: 12, 24 hours 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 carry-over 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").
  • Any Drug Effects: Peak Effect (Emax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Good Drug Effects: Peak Effect (Emax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Bad Drug Effects: Peak Effect (Emax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Feel Sick: Peak Effect (Emax) [ Time Frame: Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Nausea: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Sleepy: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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.
  • Percentage of Dose (Drug Powder) Insufflated [ Time Frame: Intervention period: 0 Hour post-dose ]
    The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.
  • Pupillometry: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • High: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • High: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • High: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Take Drug Again: Peak Effect (Emax) [ Time Frame: 12, 24 h post-dose ]
  • Take Drug Again: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ]
  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: 12, 24 h post-dose ]
  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Nausea: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Any Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Good Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Bad Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Feel Sick: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Nausea: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Sleepy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Dizzy: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "burning" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Percentage of Dose (Drug Powder) Insufflated [ Time Frame: up to 5 min post-dose ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Pupillometry: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Plasma Decay Half-Life (t1/2) of Oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Plasma Decay Half-Life (t1/2) of Oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Plasma Decay Half-Life (t1/2) of Noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Plasma Decay Half-Life (t1/2) of Naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for need to blow nose [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "runny nose/nasal discharge" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "facial pain/pressure" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour for "nasal congestion" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "need to blow nose" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "runny nose/nasal discharge" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "facial pain/pressure" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-2 Hours for "nasal congestion" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "need to blow nose" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "runny nose/nasal discharge" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "facial pain/pressure" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) for "nasal congestion" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "need to blow nose" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "runny nose/nasal discharge" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "facial pain/pressure" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) for "nasal congestion" [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 h post-dose ]
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2017)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours 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, 0-8 Hour and 0-24 Hours [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
  • High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
  • Subject Rating Scale for Nasal Effects: Peak Effect (Emax) [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose ]
    Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be"). Emax = Maximum observed score.
  • Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose ]
    Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be"). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
  • Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose ]
    Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be"). TEmax = Time to maximum observed score.
  • Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.
  • Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol [ Time Frame: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal ]
    An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.
  • Number of Participants With Clinically Significant Change in Vital Sign Examinations [ Time Frame: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal ]
    Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.
  • Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) [ Time Frame: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose ]
    End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion.
  • Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) [ Time Frame: Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours ]
    Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended Release Capsules) Compared To Oxycodone Immediate Release, And Placebo When Administered Intranasally To Non-dependent, Recreational Opioid Users.
Brief Summary The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
Detailed Description Abuse Liability Study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ALO-02 weight-matched placebo
    crushed sugar spheres (powder) x 1 dose
  • Drug: crushed ALO-02 30 mg/3.6 mg
    crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
  • Drug: oxycodone weight-matched placebo
    crushed lactose tablets (powder) x 1 dose
  • Drug: crushed oxycodone IR 30 mg
    Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
Study Arms  ICMJE
  • Placebo Comparator: Treatment A
    Intervention: Drug: ALO-02 weight-matched placebo
  • Experimental: Treatment B
    Intervention: Drug: crushed ALO-02 30 mg/3.6 mg
  • Placebo Comparator: Treatment C
    Intervention: Drug: oxycodone weight-matched placebo
  • Active Comparator: Treatment D
    Intervention: Drug: crushed oxycodone IR 30 mg
Publications * Setnik B, Bramson C, Bass A, Levy-Cooperman N, Malhotra B, Matschke K, Sommerville KW, Wolfram G, Geoffroy P. Intranasal administration of crushed ALO-02 (extended-release oxycodone with sequestered naltrexone): A randomized, controlled abuse-potential study in nondependent recreational opioid users. J Clin Pharmacol. 2015 Dec;55(12):1351-61. doi: 10.1002/jcph.552. Epub 2015 Jul 2.

*   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: September 11, 2013)
45
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)
32
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects
  • Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).
  • Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence
  • Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder.
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775189
Other Study ID Numbers  ICMJE B4531009
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 Syneos Health
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2017

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