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Completed

NCT Number: NCT01825447

A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

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 subjects
  • Non-dependent, recreational opioid users
  • Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion criteria

  • Diagnosis of substance and/or alcohol dependence
  • Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
  • History of sleep apnea.

Treatment and study plan

Placebo

Drug

0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.

Oxycodone + Naltrexone

Drug

Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.

Oxycodone

Drug

Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

Primary outcomes

  1. Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 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 visual analogue scale (VAS) anchored in the center with a neutral anchor of

  2. Drug Liking: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  3. High: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

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

  4. High: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Secondary outcomes

  1. Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 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 visual analogue scale (VAS) anchored in the center with a neutral anchor of

  2. Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  3. High: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

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

  4. High: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  5. Take Drug Again: Peak Effect (Emax)

    Time frame: 12, 24 h post-dose

    Take Drug Again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =

  6. Take Drug Again: Mean Effect (Emean)

    Time frame: 12, 24 h post-dose

  7. Overall Drug Liking: Peak Effect (Emax)

    Time frame: 12, 24 h post-dose

    Overall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =

  8. Overall Drug Liking: Mean Effect (Emean)

    Time frame: 12, 24 h post-dose

  9. Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

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

  10. Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  11. Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  12. Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

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

  13. Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h

  14. Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  15. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: 5 min, 15 min, 30 min, 45 min, 1 h post-dose

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

  16. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h

  17. Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  18. Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

    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).

  19. Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  20. Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  21. Nausea: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

    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).

  22. Nausea: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  23. Nausea: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  24. Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

    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).

  25. Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  26. Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  27. Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

    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).

  28. Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  29. Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  30. Any Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  31. Good Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  32. Bad Drug Effects: Peak Effect (Emax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  33. Feel Sick: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  34. Nausea: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  35. Sleepy: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  36. Dizzy: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  37. Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dose

    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 have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.

  38. Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose

  39. Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose

  40. Pupillometry: Peak Effect (Emax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  41. Pupillometry: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  42. Drug Liking: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  43. High: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  44. Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  45. Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  46. Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)

    Time frame: 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  47. Sleepy: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  48. Dizzy: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  49. Nausea: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  50. Feel Sick: Time to Maximum (Peak) Effect (TEmax)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  51. Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  52. Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  53. Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  54. Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  55. Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)

    Time frame: pre-dose, 5 min post-dose

  56. Plasma Decay Half-Life (t1/2) of Oxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  57. Plasma Decay Half-Life (t1/2) of Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  58. Plasma Decay Half-Life (t1/2) of Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  59. Plasma Decay Half-Life (t1/2) of Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  60. Plasma Decay Half-Life (t1/2) of 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  61. Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

    AUC is a measure of the plasma concentration of the drug over time.

  62. Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  63. Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  64. Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  65. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  66. Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  67. Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  68. Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  69. Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  70. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  71. Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  72. Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  73. Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  74. Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  75. Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  76. Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  77. Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  78. Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  79. Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  80. Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  81. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  82. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  83. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  84. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  85. Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  86. Systemic Clearance (Cl) of Oxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  87. Systemic Clearance (Cl) of Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  88. Systemic Clearance (Cl) of Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  89. Systemic Clearance (Cl) of Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  90. Systemic Clearance (Cl) of 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  91. Volume of Distribution at Steady State (Vss) for Oxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  92. Volume of Distribution at Steady State (Vss) for Oxymorphone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  93. Volume of Distribution at Steady State (Vss) for Noroxycodone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  94. Volume of Distribution at Steady State (Vss) for Naltrexone

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

  95. Volume of Distribution at Steady State (Vss) for 6-beta-naltrexol

    Time frame: pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Lifetree Clinical Research Center, Salt Lake City, Utah

Registry information

Official study title

A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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