A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

This study has been completed.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01746901
First received: December 7, 2012
Last updated: September 25, 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.


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: intact ALO-02 60 mg/7.2 mg
Drug: crushed ALO-02 60 mg/7.2 mg
Drug: crushed oxycodone IR 60 mg
Drug: crushed ALO-02 40 mg/4.8 mg
Drug: crushed oxycodone IR 40 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, 6-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 Orally to Non-Dependent, Recreational Opioid Users

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
    High visual analogue scale (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: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h 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-point bipolar VAS anchored in the center with a neutral anchor of

  • High: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: pre-dose, 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).


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) of oxymorphone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of noroxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Bad Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Bad Drug Effects visual analogue scale (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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Feel Sick visual analogue scale (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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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).

  • Pupillometry: Peak Effect (Emax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h 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.

  • Good Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Good Drug Effects visual analogue scale (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).

  • Any Drug Effects: Peak Effect (Emax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Any Drug Effects visual analogue scale (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).

  • Maximum Observed Plasma Concentration (Cmax) of oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero extrapolated to infinity (AUCinf).

  • Area under the Concentration-Time Curve (AUC0-1h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 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 Concentration-Time Curve (AUC0-2h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2 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 Concentration-Time Curve (AUC0-8h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 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 Concentration-Time Curve (AUC0-12h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 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 Concentration-Time Curve (AUC0-24h) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24 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.

  • Plasma Decay Half-Life (t1/2) for oxycodone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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.

  • Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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.

  • Good Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
    Good 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.

  • Any Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
    Any 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 Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h post-dose ] [ Designated as safety issue: No ]
    Bad 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.

  • Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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.

  • Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 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.

  • Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, and 36 h 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.

  • Take Drug Again: Peak Effect (Emax) [ Time Frame: 12, 24, 36 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 = definitely not; 50 = neutral; 100 = definitely so).

  • Take Drug Again: Mean Effect (Emean) [ Time Frame: 12, 24, 36 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 = definitely not; 50 = neutral; 100 = definitely so).

  • Take Drug Again: Minimum Effect (Emin) [ Time Frame: 12, 24, 36 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 = definitely not; 50 = neutral; 100 = definitely so).

  • Overall Drug Liking: Peak Effect (Emax) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Overall Drug Liking visual analogue scale (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 = strong disliking; 50 = neither like nor dislike; 100 = strong liking)

  • Overall Drug Liking: Minimum Effect (Emin) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Overall Drug Liking visual analogue scale (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 = strong disliking; 50 = neither like nor dislike; 100 = strong liking)

  • Overall Drug Liking: Mean Effect (Emean) [ Time Frame: 12, 24, 36 h post-dose ] [ Designated as safety issue: No ]
    Overall Drug Liking visual analogue scale (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 = strong disliking; 50 = neither like nor dislike; 100 = strong liking)

  • Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 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

  • High: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 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).

  • Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 0-1 Hours [ Time Frame: pre-dose, 1 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h 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 zero to time of last quantifiable effect (0-1).

  • Good Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
    Good 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 Effects: Area Under Effect Curve (AUE) From 0-1 Hours [ Time Frame: 0, 1 h post-dose ] [ Designated as safety issue: No ]
    Any 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 Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 0-2 Hours [ Time Frame: pre-dose, 2 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h 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 zero to time of last quantifiable effect (0-2).

  • Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
    Good 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 Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 0, 2 h post-dose ] [ Designated as safety issue: No ]
    Any 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).

  • Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 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 0-12 Hours [ Time Frame: 0, 12 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, 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

  • Drug Liking: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 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 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
    High visual analogue scale (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 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
    High visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • High: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
    High visual analogue scale (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).

  • High: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
    High visual analogue scale (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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
    Any 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 Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
    Any 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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
    Any 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).

  • Any Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
    Any 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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
    Good 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 Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
    Good 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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
    Good 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 Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
    Good 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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 Effects: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h post-dose ] [ Designated as safety issue: No ]
    Bad effects visual analogue scale (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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
    Feel sick visual analogue scale (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 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
    Nausea visual analogue scale (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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
    Sleepy visual analogue scale (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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: pre-dose, 8 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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 0-12 Hours [ Time Frame: pre-dose, 12 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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 (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: pre-dose, 24 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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 0-36 Hours [ Time Frame: pre-dose, 36 h post-dose ] [ Designated as safety issue: No ]
    Dizzy visual analogue scale (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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours [ Time Frame: 0, 8 h 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 zero to time of last quantifiable effect (0-8).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 0, 12 h 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 zero to time of last quantifiable effect (0-12).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours [ Time Frame: 0, 24 h 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 zero to time of last quantifiable effect (0-24).

  • Pupillometry: Area Under Effect Curve (AUE) From 0-36 Hours [ Time Frame: 0, 36 h 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 (0-36) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-36).

  • Maximum Observed Plasma Concentration (Cmax) of naltrexone [ Time Frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 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, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 h post-dose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Drug: Placebo
Placebo solution + Placebo ALO-02 (intact)
Experimental: Treatment B Drug: intact ALO-02 60 mg/7.2 mg
Placebo solution + ALO-02 60 mg/7.2 mg (intact)
Experimental: Treatment C Drug: crushed ALO-02 60 mg/7.2 mg
crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
Active Comparator: Treatment D Drug: crushed oxycodone IR 60 mg
crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
Experimental: Treatment E Drug: crushed ALO-02 40 mg/4.8 mg
crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
Active Comparator: Treatment F Drug: crushed oxycodone IR 40 mg
crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)

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 before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence.
  • Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
  • History of sleep apnea.
  • Positive urine drug screen (UDS) for other that marijuana.
  • Positive for Hepatitis B or C and HIV on Screening.
  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: NCT01746901

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: NCT01746901     History of Changes
Other Study ID Numbers: B4531008
Study First Received: December 7, 2012
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers
Chronic pain

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 23, 2014