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Abuse Potential Study of PF-00345439

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986283
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

Brief Summary:
This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.

Condition or disease Intervention/treatment Phase
Opioid Users Drug: Capsule Drug: PF-00345439 Drug: oxycodone Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Administered Orally Whole And/or Chewed To Non-dependent, Recreational Opioid Users Under Fasted Conditions
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
Placebo Comparator: Treatment A
Placebo solution +placebo capsule + placebo capsule chewed.
Drug: Capsule
Taken once

Experimental: Treatment B
PF-00345439 taken whole + placebo solution + placebo chewed
Drug: PF-00345439
40 mg capsule swallowed whole, taken once

Experimental: Treatment C
PF-00345439 chewed + placebo solution + placebo taken whole
Drug: PF-00345439
40 mg capsule chewed, taken once

Active Comparator: Treatment D
Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed
Drug: oxycodone
40 mg solution, taken once




Primary Outcome Measures :
  1. Drug Liking: Peak Effect (Emax) [ Time Frame: 12 hours ]
    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 unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

  2. High: Peak Effect (Emax) [ Time Frame: 12 hours ]
    High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.

  3. Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    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 unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

  4. High: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.


Secondary Outcome Measures :
  1. Take Drug Again Effect at 24 Hours [ Time Frame: 24 hours ]
    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 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Definately not and score of 100 mm = Definately so).

  2. Overall Drug Liking [ Time Frame: 24 hours ]
    Overall Drug Liking visual analogue scale (VAS) is a subjective assessment of the degree to which a participant likes the drug overall. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Not at all and 100 mm = Extremely).

  3. Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  4. Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    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).

  5. Chewing Duration [ Time Frame: 5 min ]
    Chewing duration is a measurement of the total time a person is able to chew.

  6. Taste: Subjective Experience from Chewing [ Time Frame: 5 min ]
    Subjective Experience from Chewing is a visual analogue scale (VAS) subjective assessment of the taste of the substance being chewed. Participants are asked to describe the taste of the drug using a VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Extremely unpleasant, 50 mm = neutral, and 100 mm = Extremely pleasant).

  7. Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  8. Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  9. Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    Any drug effects effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  10. Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    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).

  11. Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    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 (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  12. Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    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).

  13. High: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  14. High: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  15. High: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  16. Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  17. Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  18. Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  19. Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  20. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  21. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hour ]
    Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  22. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  23. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  24. Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  25. Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  26. Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  27. Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    Feeling sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  28. Nausea: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  29. Nausea: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  30. Nausea: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  31. Nausea: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  32. Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  33. Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  34. Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  35. Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour [ Time Frame: 12 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  36. Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-1).

  37. Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours [ Time Frame: 2 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-2).

  38. Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-3) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-3).

  39. Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  40. Bad Effects: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Bad effects visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  41. Nausea: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Nausea visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  42. Feel Sick: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Feel sick visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  43. Sleepy: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Sleepy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  44. Dizzy: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Dizzy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  45. Pupillometry: Peak Effect (Emax) [ Time Frame: 12 hours ]
    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.

  46. Good Drug Effects: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-12).

  47. Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour [ Time Frame: 1 hour ]
    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 unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  48. Drug Liking: Area Under Effect Curve (AUE) From 0-3 Hours [ Time Frame: 3 hours ]
    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 unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  49. Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours [ Time Frame: 12 hours ]
    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 unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  50. Drug Liking: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    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 unipolar visual analogue scale (VAS), where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  51. High: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  52. Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Any drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  53. Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Good drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  54. Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Bad drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  55. Feel Sick: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  56. Nausea: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  57. Sleepy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    Sleepy visual analogue scale (VAS) assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  58. Dizzy: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    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 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.

  59. Pupillometry: Time to Maximum (Peak) Effect (TEmax) [ Time Frame: 12 hours ]
    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 maximum observed score.

  60. Any Drug Effects: Peak Effect (Emax) [ Time Frame: 12 hours ]
    Any drug effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'not at all' (score of 0 mm) to 'extremely' (score of 100 mm).

  61. Texture: Subjective Experience from Chewing [ Time Frame: 5 mins ]
    Subjective Experience from Chewing is a visual analogue scale (VAS) subjective assessment of the texture of the substance being chewed. Participants are asked to describe the the texture of the drug using a VAS with score ranging from 0 mm to 100 mm (score of 0 mm = Extremely unpleasant, 50 mm = neutral, and 100 mm = Extremely pleasant).

  62. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 24hr ]
  63. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 24hr ]
  64. Area under the curve (AUC) [ Time Frame: 24hr ]
  65. Systemic Clearance (CL) [ Time Frame: 24hr ]
  66. volume of distribution (Vd) [ Time Frame: 24hr ]
  67. Half-Life (t1/2) [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids.

Exclusion Criteria:

  • Evidence or history of clinically significant medical conditions.
  • Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
  • Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
  • Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
  • Has a positive alcohol breath test.
  • Has any history of a condition in which an opioid is contraindicated.
  • History of sleep apnea in the past 5 years that has not been resolved or corrected.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results .
  • Positive test for Hepatitis B, Hepatitis C, or HIV.
  • Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986283


Locations
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United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Pain Therapeutics
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT01986283    
Other Study ID Numbers: B4501016
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Keywords provided by PainT ( Pain Therapeutics ):
Abuse potential
PF-00345439
drug abuse
Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents