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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01595867
Pfizer
Completed
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

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[email protected]

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