Expired Study
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Salt Lake City, Utah 84106


Purpose:

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.


Criteria:

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 1. - 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.


Study is Available At:


Original ID:

ALO-01-10-4005


NCT ID:

NCT01380093


Secondary ID:

B4541003


Study Acronym:


Brief Title:

Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:February 2011
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:September 2011
Last Changed Date:September 22, 2011
First Received Date:June 22, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:VAS - High - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:VAS - Drug Liking - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Sleepy - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Sleepy - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Any Drug Effects - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine Tmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine Cmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Take Drug Again - Effect at 24h
Time Frame:24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall Drug Liking - Effect at 24h
Time Frame:24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - High - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Drug Liking - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol Tmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Nausea - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Feel Sick - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Good Effects - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-inf)
Time Frame:0-inf post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Bad Effects - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol AUC (0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Sleepy - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:6-β-naltrexol Cmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-inf)
Time Frame:0-inf post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone AUC (0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone Tmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Naltrexone Cmax
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-inf)
Time Frame:0-inf post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Morphine AUC (0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pupillometry - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Time of Peak Effect (TEmax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Peak Effect (Emax)
Time Frame:up to 24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-24h)
Time Frame:0-24 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-12h)
Time Frame:0-12 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-8h)
Time Frame:0-8 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-4h)
Time Frame:0-4 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-2h)
Time Frame:0-2 hrs post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:VAS - Dizzy - Area Under Effect Curve (AUE 0-1h)
Time Frame:0-1 hr post dose
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Single-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
Arm Name:Placebo
Intervention Type:Drug
Name:MS Contin (morphine sulfate, controlled release)
Description:Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Arm Name:MS Contin (morphine sulfate, controlled release)
Intervention Type:Drug
Name:EMBEDA (morphine sulfate / naltrexone hydrochlorid
Description:Single-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
Arm Name:EMBEDA (morphine sulfate / naltrexone hydrochlorid

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Active Comparator
Arm Name:MS Contin (morphine sulfate, controlled release)
Study Arm Type:Experimental
Arm Name:EMBEDA (morphine sulfate / naltrexone hydrochloride)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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