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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Narcotic Abuse; Opioid-related Disorders; Analgesia; Chronic Pain

Intervention: Placebo (Drug); EMBEDA - morphine sulfate/ naltrexone hydrochloride (Drug); morphine sulfate CR crushed. (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome:

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:

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)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2010
Last updated: June 7, 2012

Page last updated: August 23, 2015

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