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MS Contin

Phase 1

Nondependent Opioid Abuse, Episodic | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: May 31, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

MS Contin · 1 trial · 1 indication

Phase 1 1
NCT01380093Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid UsersNondependent Opioid Abuse, Episodic
COMPLETED80 Analytics
PHASE1COMPLETED
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Nondependent Opioid Abuse, EpisodicUnlock trial analytics

Study Endpoints

Primary Endpoints

Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
0.5, 1, 1.5 and 2 hrs post-dose

Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).

Drug Liking: Peak Effect (Emax)
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose

Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.

High: Area Under Effect Curve (AUE) From 0-2 Hours
0.5, 1, 1.5 and 2 hrs post-dose

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).

High: Peak Effect (Emax)
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.

Secondary Endpoints

Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
0.5 and 1 hrs post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
MS Contin (morphine sulfate, controlled release)ACTIVE_COMPARATOR -
EMBEDA (morphine sulfate / naltrexone hydrochloride)EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGSingle-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
MS Contin (morphine sulfate, controlled release)DRUGSingle-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
EMBEDA (morphine sulfate / naltrexone hydrochloride)DRUGSingle-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is a recreational opioid user who is NOT physically 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 recreationall...

Countries:United States
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Frequently asked questions about MS Contin

What is MS Contin used for?

MS Contin is an investigational small molecule being studied for the treatment of nondependent opioid abuse, episodic. It is a controlled-release morphine formulation. The drug is in Phase 1 clinical development and is not approved for this use.

Who makes MS Contin?

MS Contin is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research on this drug for the treatment of nondependent opioid abuse, episodic.

What phase is MS Contin in?

MS Contin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this drug.

What clinical trials is MS Contin in?

MS Contin has one completed clinical trial, NCT01380093, which was a Phase 1 study. The trial evaluated the abuse potential of orally administered crushed MS Contin compared to crushed Embeda and placebo in non-dependent recreational opioid users.

Is MS Contin the same as Embeda?

No, MS Contin is not the same as Embeda. MS Contin is a controlled-release morphine formulation, while Embeda is a different drug. In a clinical trial, MS Contin was compared against Embeda and placebo to assess abuse potential.