FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01595867
Enrollment
33
Registered
2012-05-10
Start date
2010-08-31
Completion date
2011-01-31
Last updated
2012-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

abuse liability, abuse potential, morphine, intranasal administration, snorting, opioid abuse, pharmacodynamic, recreational drug use

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.

Interventions

DRUGPlacebo

Lactose (100 mg) placebo tablets crushed; single dose

DRUGEMBEDA - morphine sulfate/ naltrexone hydrochloride

EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose

DRUGmorphine sulfate CR crushed.

Morphine sulfate controlled release 30 mg tablet crushed

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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
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
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
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

Secondary

MeasureTime frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Take Drug Again Visual Analog Scale maximum peak effect (Emax)12 and 24 hours post dose
Take Drug Again Visual Analog Scale mean (Emean)12 and 24 hours post dose
Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)12 and 24 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)pre dose and 0.5, 1, 1.5, and 2 hours post dose
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
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
Subject Rating Scale - Burning maximum peak effect (Emax)pre dose and 0.5, 1, 1.5, and 2 hours post dose
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
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
Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)pre dose and 0.5, 1, 1.5, and 2 hours post dose
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
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
Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)pre dose and 0.5, 1, 1.5, and 2 hours post dose
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
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
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
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
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
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
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
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
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
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
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
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
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
Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmaxpre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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
Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicablepre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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
Overall Drug Liking Visual Analog Scale mean (Emean)12 and 24 hours post dose
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
Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicablepre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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
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
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
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
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
Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicablepre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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
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
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
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
Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)pre dose and 0.5, 1, 1.5, and 2 hours post dose
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026