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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595867
• Other study ID #: ALO-01-10-4004
• Secondary ID: B4541005
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2012
• Last updated: June 7, 2012
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Analgesia
• Chronic Pain
• Narcotic Abuse
• Opioid-related Disorders

Intervention

Drug:
• Placebo
Lactose (100 mg) placebo tablets crushed; single dose
• EMBEDA - morphine sulfate/ naltrexone hydrochloride
EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
• morphine sulfate CR crushed.
Morphine sulfate controlled release 30 mg tablet crushed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	High Visual Analog Scale Area time to maximum effect (TEmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Any Drug Effects Visual Analog Scale maximum peak effect (Emax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Any Drug Effects 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	No
Secondary	Any Drug Effects 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	No
Secondary	Any Drug Effects 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	No
Secondary	Any Drug Effects 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	No
Secondary	Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Good Drug Effects Visual Analog Scale maximum peak effect (Emax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Good Drug Effects 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	No
Secondary	Good Drug Effects 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	No
Secondary	Good Drug Effects 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	No
Secondary	Good Drug Effects 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	No
Secondary	Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Bad Drug Effects 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	No
Secondary	Bad Drug Effects 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	No
Secondary	Bad Drug Effects 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	No
Secondary	Bad Drug Effects 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	No
Secondary	Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)		0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick 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	No
Secondary	Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick 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	No
Secondary	Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea 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	No
Secondary	Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea 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	No
Secondary	Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Nausea Visual Analog Scale Area time to maximum effect (TEmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy 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	No
Secondary	Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy 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	No
Secondary	Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Sleepy Visual Analog Scale Area time to maximum effect (TEmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy 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	No
Secondary	Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy 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	No
Secondary	Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Dizzy Visual Analog Scale Area time to maximum effect (TEmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter minimum peak effect (Emin)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter time to minimum peak effect (TEmin)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter 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	No
Secondary	Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose	No
Secondary	Take Drug Again Visual Analog Scale maximum peak effect (Emax)		12 and 24 hours post dose	No
Secondary	Take Drug Again Visual Analog Scale mean (Emean)		12 and 24 hours post dose	No
Secondary	Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)		12 and 24 hours post dose	No
Secondary	Overall Drug Liking Visual Analog Scale mean (Emean)		12 and 24 hours post dose	No
Secondary	Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Burning maximum peak effect (Emax)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)		pre dose and 0.5, 1, 1.5, and 2 hours post dose	No
Secondary	Plasma morphine - Maximum observed plasma concentration (Cmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Time to maximum observed plasma concentration (Tmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Maximum observed plasma concentration (Cmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No
Secondary	Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)		pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose	No

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