search
Back to results

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

Primary Purpose

Narcotic Abuse, Opioid-related Disorders, Analgesia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
EMBEDA - morphine sulfate/ naltrexone hydrochloride
morphine sulfate CR crushed.
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Narcotic Abuse focused on measuring abuse liability, abuse potential, morphine, intranasal administration, snorting, opioid abuse, pharmacodynamic, recreational drug use

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Active Comparator

    Arm Label

    Treatment A

    Treatment B

    Treatment C

    Arm Description

    Placebo

    EMBEDA 30 mg crushed

    Morphine Sulfate Controlled Release 30 mg crushed

    Outcomes

    Primary Outcome Measures

    Drug Liking Visual Analog Scale maximum peak effect (Emax)
    Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    High Visual Analog Scale maximum peak effect (Emax)
    High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)

    Secondary Outcome Measures

    Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)
    High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    High Visual Analog Scale Area time to maximum effect (TEmax)
    Any Drug Effects Visual Analog Scale maximum peak effect (Emax)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
    Good Drug Effects Visual Analog Scale maximum peak effect (Emax)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
    Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
    Feel Sick Visual Analog Scale maximum peak effect (Emax)
    Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)
    Nausea Visual Analog Scale maximum peak effect (Emax)
    Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Nausea Visual Analog Scale Area time to maximum effect (TEmax)
    Sleepy Visual Analog Scale maximum peak effect (Emax)
    Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Sleepy Visual Analog Scale Area time to maximum effect (TEmax)
    Dizzy Visual Analog Scale maximum peak effect (Emax)
    Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
    Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
    Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
    Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
    Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
    Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
    Dizzy Visual Analog Scale Area time to maximum effect (TEmax)
    Pupil Diameter minimum peak effect (Emin)
    Pupil Diameter time to minimum peak effect (TEmin)
    Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)
    Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)
    Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)
    Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)
    Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)
    Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)
    Take Drug Again Visual Analog Scale maximum peak effect (Emax)
    Take Drug Again Visual Analog Scale mean (Emean)
    Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)
    Overall Drug Liking Visual Analog Scale mean (Emean)
    Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)
    Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)
    Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)
    Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)
    Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)
    Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)
    Subject Rating Scale - Burning maximum peak effect (Emax)
    Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)
    Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)
    Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)
    Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)
    Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)
    Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)
    Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)
    Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)
    Plasma morphine - Maximum observed plasma concentration (Cmax)
    Plasma morphine - Time to maximum observed plasma concentration (Tmax)
    Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
    Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
    Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
    Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)
    Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
    Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
    Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
    Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
    Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
    Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax
    Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
    Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
    Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
    Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
    Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
    Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
    Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
    Plasma naltrexone - Maximum observed plasma concentration (Cmax)
    Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)
    Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)

    Full Information

    First Posted
    May 8, 2012
    Last Updated
    June 7, 2012
    Sponsor
    Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01595867
    Brief Title
    Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
    Keywords
    abuse liability, abuse potential, morphine, intranasal administration, snorting, opioid abuse, pharmacodynamic, recreational drug use

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    Treatment B
    Arm Type
    Experimental
    Arm Description
    EMBEDA 30 mg crushed
    Arm Title
    Treatment C
    Arm Type
    Active Comparator
    Arm Description
    Morphine Sulfate Controlled Release 30 mg crushed
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Lactose (100 mg) placebo tablets crushed; single dose
    Intervention Type
    Drug
    Intervention Name(s)
    EMBEDA - morphine sulfate/ naltrexone hydrochloride
    Intervention Description
    EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
    Intervention Type
    Drug
    Intervention Name(s)
    morphine sulfate CR crushed.
    Intervention Description
    Morphine sulfate controlled release 30 mg tablet crushed
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Take Drug Again Visual Analog Scale maximum peak effect (Emax)
    Time Frame
    12 and 24 hours post dose
    Title
    Take Drug Again Visual Analog Scale mean (Emean)
    Time Frame
    12 and 24 hours post dose
    Title
    Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)
    Time Frame
    12 and 24 hours post dose
    Title
    Overall Drug Liking Visual Analog Scale mean (Emean)
    Time Frame
    12 and 24 hours post dose
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Subject Rating Scale - Burning maximum peak effect (Emax)
    Time Frame
    pre dose and 0.5, 1, 1.5, and 2 hours post dose
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)
    Time Frame
    pre dose and 0.5, 1, 1.5, and 2 hours post dose
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23936895
    Citation
    Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082.
    Results Reference
    derived
    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4004&StudyName=Abuse%20Potential%20Assessment%20of%20Intranasally%20Administered%20EMBEDA%20Compared%20To%20Morphine%20Sulfate%20Controlled%20Release%20And%20Placebo%20
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs