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Completed

NCT Number: NCT01595867

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

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.

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Key information

Conditions

Narcotic Abuse Agnosia Analgesia Behavior Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Recreational Drug Use Signs and Symptoms Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Placebo

Drug

Lactose (100 mg) placebo tablets crushed; single dose

EMBEDA - morphine sulfate/ naltrexone hydrochloride

Drug

EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose

morphine sulfate CR crushed.

Drug

Morphine sulfate controlled release 30 mg tablet crushed

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 10, 2012
Registry last updated
Jun 8, 2012

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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