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EMBEDA- morphine/ naltrexone

Phase 1

Narcotic Abuse | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jun 8, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

EMBEDA- morphine/ naltrexone · 1 trial · 4 indications

Phase 1 1
NCT01595867Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And PlaceboNarcotic Abuse
COMPLETED33 Analytics
PHASE1COMPLETED
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
Narcotic Abuse
NCT0159586733
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment APLACEBO_COMPARATORPlacebo
Treatment BEXPERIMENTALEMBEDA 30 mg crushed
Treatment CACTIVE_COMPARATORMorphine Sulfate Controlled Release 30 mg crushed

Interventions

NameTypeDescription
PlaceboDRUGLactose (100 mg) placebo tablets crushed; single dose
EMBEDA - morphine sulfate/ naltrexone hydrochlorideDRUGEMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
morphine sulfate CR crushed.DRUGMorphine sulfate controlled release 30 mg tablet crushed
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

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...

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