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Clinical Trials/NCT01380093
NCT01380093CompletedPhase 1

A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users

Pfizer1 site in 1 country80 target enrollmentStarted: February 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Enrollment
80
Locations
1
Primary Endpoint
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 recreationally abusing 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 prior to Visit
  • •Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

  • •Has a history or current diagnosis of substance 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).
  • •History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • •Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
  • •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).
  • •Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.

Arms & Interventions

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

MS Contin (morphine sulfate, controlled release)

Active Comparator

Intervention: MS Contin (morphine sulfate, controlled release) (Drug)

EMBEDA (morphine sulfate / naltrexone hydrochloride)

Experimental

Intervention: EMBEDA (morphine sulfate / naltrexone hydrochloride) (Drug)

Outcomes

Primary Outcomes

Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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 Outcomes

  • Good Effects: 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 0-1 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)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Drug Liking: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • High: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • High: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • High: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • High: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • High: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • High: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Good Effects: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Good Effects: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Any Effects: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Any Effects: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Bad Effects: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Bad Effects: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-1 Hour(Pre-dose, 0.5 and 1 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-2 Hours(Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-4 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-8 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-12 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Nausea: Area Under Effect Curve (AUE) From 0-24 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Nausea: Peak Effect (Emax)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Nausea: Time to Maximum (Peak) Effect (TEmax)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Feel Sick: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Feel Sick: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Sleepy: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Sleepy: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour(0.5 and 1 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours(0.5, 1, 1.5 and 2 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours(0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours(0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Dizzy: Peak Effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Dizzy: Time to Maximum (Peak) Effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Overall Drug Liking Effect at 24 Hours(24 hrs post dose)
  • Take Drug Again Effect at 24 Hours(24 hrs post dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour(Pre-dose, 0.5 and 1 hrs post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours(Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Pupillometry: Peak Effect (Emax)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Pupillometry: Time to Maximum (Peak) Effect (TEmax)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Maximum Observed Plasma Concentration (Cmax) of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine(Pre-dose, 0.5 and 1 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine(Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone(Pre-dose, 0.5 and 1 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone(Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5 and 1 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)(Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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