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

This study has been completed.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01775189
First received: January 22, 2013
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ALO-02 weight-matched placebo
Drug: crushed ALO-02 30 mg/3.6 mg
Drug: oxycodone weight-matched placebo
Drug: crushed oxycodone IR 30 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Double-Dummy, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • High: 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 ] [ Designated as safety issue: No ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2 h 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  • 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 ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of


Secondary Outcome Measures:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0, 0.25, 0.5, 0.75, 1 h 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  • 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 ] [ 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  • 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 ] [ 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  • High: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Take Drug Again: Peak Effect (Emax) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
    Take drug again visual analogue scale (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-point VAS with score ranging from 0 to 100 (score of 0 =

  • Take Drug Again: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: 12, 24 h 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-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =

  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: 12, 24 h post-dose ] [ Designated as safety issue: No ]
  • Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • 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 ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).

  • 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 ] [ Designated as safety issue: Yes ]
    A 6-point scale assessing 5 categories: burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion.

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of dose (drug powder) insufflated [ Time Frame: up to 5 min post-dose ] [ Designated as safety issue: No ]
    Weight of drug powder remaining (if any) after dosing.

  • 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 ] [ Designated as safety issue: No ]
    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. AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  • 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 ] [ Designated as safety issue: No ]
    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. AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  • 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 ] [ Designated as safety issue: No ]
    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. AUE (0-8) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-8).

  • 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 ] [ Designated as safety issue: No ]
    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. AUE (0-24) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-24).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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. TEmax = Time to smallest post-dose pupil size.

  • 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 ] [ 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-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of

  • 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 ] [ Designated as safety issue: No ]
    High VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Any Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Good Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Bad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Sleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Dizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Nausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
    Feel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100). TEmax = Time to maximum observed score.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Area Under the Oxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
    AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.

  • Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Naltrexone Concentration-Time Curve (AUC0-1h) [ Time Frame: pre-dose, 0.25, 0.5, 0.75, 1 h post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Drug: ALO-02 weight-matched placebo
crushed sugar spheres (powder) x 1 dose
Experimental: Treatment B Drug: crushed ALO-02 30 mg/3.6 mg
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
Placebo Comparator: Treatment C Drug: oxycodone weight-matched placebo
crushed lactose tablets (powder) x 1 dose
Active Comparator: Treatment D Drug: crushed oxycodone IR 30 mg
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose

Detailed Description:

Abuse Liability Study

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775189

Locations
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Pfizer
INC Research
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01775189     History of Changes
Other Study ID Numbers: B4531009
Study First Received: January 22, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative abuse potential study
Chronic pain
oxycodone
naltrexone
opioid-related disorders
drug abusers

Additional relevant MeSH terms:
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014