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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01595867
First received: May 8, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Take Drug Again Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale maximum peak effect (Emax) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • Overall Drug Liking Visual Analog Scale mean (Emean) [ Time Frame: 12 and 24 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Burning maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject Rating Scale - Nasal Congestion maximum peak effect (Emax) [ Time Frame: pre dose and 0.5, 1, 1.5, and 2 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595867

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01595867     History of Changes
Other Study ID Numbers: ALO-01-10-4004, B4541005
Study First Received: May 8, 2012
Last Updated: June 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
abuse liability
abuse potential
morphine
intranasal administration
snorting
opioid abuse
pharmacodynamic
recreational drug use

Additional relevant MeSH terms:
Opioid-Related Disorders
Chronic Pain
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naltrexone
Morphine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on August 28, 2014