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Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

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: NCT01595867
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

Condition or disease Intervention/treatment Phase
Narcotic Abuse Opioid-related Disorders Analgesia Chronic Pain Drug: Placebo Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride Drug: morphine sulfate CR crushed. Phase 1

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Treatment A
Placebo
 Drug: Placebo
Lactose (100 mg) placebo tablets crushed; single dose
Experimental: Treatment B
EMBEDA 30 mg crushed
 Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride
EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
Active Comparator: Treatment C
Morphine Sulfate Controlled Release 30 mg crushed
 Drug: morphine sulfate CR crushed.
Morphine sulfate controlled release 30 mg tablet crushed


Outcome Measures
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Primary Outcome Measures :
  1. Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  2. Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  3. High Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  4. High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]

Secondary Outcome Measures :
  1. Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  2. Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  3. Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  4. Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  5. Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  6. Drug Liking Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  7. High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  8. High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  9. High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  10. High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  11. High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  12. High Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  13. Any Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  14. Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  15. Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  16. Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  17. Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  18. Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  19. Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  20. Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  21. Good Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  22. Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  23. Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  24. Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  25. Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  26. Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  27. Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  28. Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  29. Bad Drug Effects Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  30. Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  31. Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  32. Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  33. Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  34. Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  35. Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  36. Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  37. Feel Sick Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  38. Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  39. Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  40. Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  41. Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  42. Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  43. Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  44. Feel Sick Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  45. Nausea Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  46. Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  47. Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  48. Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  49. Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  50. Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  51. Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  52. Nausea Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  53. Sleepy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  54. Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  55. Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  56. Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  57. Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  58. Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  59. Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  60. Sleepy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  61. Dizzy Visual Analog Scale maximum peak effect (Emax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  62. Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  63. Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  64. Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  65. Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  66. Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  67. Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  68. Dizzy Visual Analog Scale Area time to maximum effect (TEmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  69. Pupil Diameter minimum peak effect (Emin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  70. Pupil Diameter time to minimum peak effect (TEmin) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  71. Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  72. Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  73. Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  74. Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  75. Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  76. Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose ]
  77. Take Drug Again Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ]
  78. Take Drug Again Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ]
  79. Overall Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ]
  80. Overall Drug Liking Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ]
  81. Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  82. Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  83. Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  84. Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  85. Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  86. Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  87. Subject Rating Scale - Burning maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  88. Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  89. Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  90. Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  91. Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  92. Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  93. Subject Rating Scale - Nasal Congestion maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  94. Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  95. Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ]
  96. Plasma morphine - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  97. Plasma morphine - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  98. Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  99. Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  100. Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  101. Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  102. Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  103. Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  104. Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  105. Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  106. Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  107. Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  108. Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  109. Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  110. Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  111. Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  112. Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  113. Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  114. Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  115. Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  116. Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  117. Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  118. Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  119. Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  120. Plasma naltrexone - Maximum observed plasma concentration (Cmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  121. Plasma naltrexone - Time to maximum observed plasma concentration (Tmax) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]
  122. Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose ]

Eligibility Criteria
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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 or female subjects 18 to 55 years of age, inclusive.
  • Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
  • Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.

Exclusion Criteria:

  • Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
  • Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
  • Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
  • Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
  • History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
  • History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
Contacts and Locations
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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): NCT01595867


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01595867    
Other Study ID Numbers: ALO-01-10-4004
B4541005
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Pfizer:
abuse liability
abuse potential
morphine
intranasal administration
 snorting
opioid abuse
pharmacodynamic
recreational drug use
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Narcotic-Related Disorders
Pain
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Morphine
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists