Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories

Exclusion Criteria

• •History of clinically significant gastrointestinal, renal, hepatic, endocrine, oncologic, hematologic, neurologic, psychologic, immunologic or pulmonary disorders; or cardiovascular disease, tuberculosis, epilepsy, diabetes, psychosis, glaucoma, or any condition which in the opinion of the Investigator would jeopardize the safety of the subject or impact study results or prevent the subject from completing the study.
• •Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorders other than substance abuse (including bipolar disorder, any psychotic disorder, and Tourette's disorder or family history of Tourette's).
• •Serious suicidal risk determined by the investigator.
• •Presence of a severe learning difficulty or mental retardation, or any condition that would interfere with participation or completion of the study.
• •History of allergic or adverse response or hypersensitivity to d-amphetamine or NRP104.
• •Participation in a previous clinical trial within 30 days prior to study initiation.
• •Blood loss, donation of one pint or more, or plasma donation within 60 days prior to study initiation.
• •Clinically significant abnormalities at screening or admission on results of ECG or lab tests, including lab deviations requiring acute medical intervention or further medical attention.
• •Treated with a monoamine oxidase inhibitor, currently or within 13 days of initiation of the study medication.
• •Require any of the following medications: clonidine or other alpha-2 adrenergic receptor agonists, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) theophylline, coumarin anticoagulants, or anticonvulsants; or have taken an SSRI in the 35 days before initiation of the study medication.
• •Currently physically dependent on benzodiazepines as determined by clinical evaluation and/or urine drug screen at screening.
• •Currently physically dependent on opiates as determined by naloxone challenge.
• •Currently physically dependent on alcohol as determined by clinical evaluation or has a positive Breathalyzer test at screening or admission and confirmed by a second reading.
• •Preexisting severe gastrointestinal narrowing.
• •Use of any prescription medications (except birth control methods) within 14 days of admission, or will require any prescription medications, or any over-the-counter (OTC) medications (other than acetaminophen), or herbal supplements or vitamins during the study.
• •Positive urine pregnancy test at screening or admission.
• •Female subject is pregnant or lactating.
• •Another member of the subject's household currently participating in the study.