Clinical trial NCT01595867: Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Narcotic Abuse
Opioid-related Disorders
Analgesia
Chronic Pain
Keywords: abuse liability
abuse potential
morphine
intranasal administration
snorting
opioid abuse
pharmacodynamic
recreational drug use
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Drug Liking Visual Analog Scale maximum peak effect (Emax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale maximum peak effect (Emax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Secondary outcomes:
measure: Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: High Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale maximum peak effect (Emax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale maximum peak effect (Emax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale maximum peak effect (Emax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale maximum peak effect (Emax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Nausea Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale maximum peak effect (Emax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Sleepy Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale maximum peak effect (Emax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Dizzy Visual Analog Scale Area time to maximum effect (TEmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter minimum peak effect (Emin)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter time to minimum peak effect (TEmin)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
measure: Take Drug Again Visual Analog Scale maximum peak effect (Emax)
timeFrame: 12 and 24 hours post dose
measure: Take Drug Again Visual Analog Scale mean (Emean)
timeFrame: 12 and 24 hours post dose
measure: Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)
timeFrame: 12 and 24 hours post dose
measure: Overall Drug Liking Visual Analog Scale mean (Emean)
timeFrame: 12 and 24 hours post dose
measure: Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Burning maximum peak effect (Emax)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)
timeFrame: pre dose and 0.5, 1, 1.5, and 2 hours post dose
measure: Plasma morphine - Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Time to maximum observed plasma concentration (Tmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
measure: Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
timeFrame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082.