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Completed

NCT Number: NCT01986283

Abuse Potential Study of PF-00345439

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Capsule

Drug

Taken once

PF-00345439

Drug

40 mg capsule swallowed whole, taken once

Oxycodone

Drug

40 mg solution, taken once

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pain Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
Registry last updated
Apr 4, 2016

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