- 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
- 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.