Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
This is a human inpatient clinical pharmacology study to assess potential interactions
 between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate
 (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH
 concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures
 include cardiovascular responses [heart rate (HR), blood pressure (BP), and
 electrocardiograph (ECG) measurements], oral temperature, adverse events (AEs), and clinical
 laboratory analyses.
Inclusion Criteria:

 -  Be volunteers who meet DSM-IV criteria for methamphetamine abuse or dependence
 determined using a Mini-International Neuropsychiatric Interview (MINI) and be
 non-treatment seeking at time of study and have a positive urine test for
 methamphetamine (greater than or = to 500 ng/mL) during screening.

 -  Be able to verbalize understanding of consent form, able to provide written informed
 consent, and verbalize willingness to complete study procedures.

 -  Have a negative urine test for methamphetamine and other drugs of abuse (opiates,
 cocaine, and benzodiazepines) after clinic intake before the first infusion session.

 -  Have a history and physical examination that demonstrate no clinically significant
 contraindication for participating in the study, in the judgment of the admitting
 physician and the site Principal Investigator

 -  Have vital signs as follows: resting heart rate between 45 and 100 bpm, systolic BP
 below 140 mm Hg and diastolic BP below 90 mm Hg.

 -  Have electrolytes (Na, K, Cl, HCO3) and hematocrit that is clinically normal (+/- 10%
 of laboratory limits).

 -  Have liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) less
 than three times the upper limit of normal.

 -  Have kidney function tests (creatinine and BUN) less than twice the upper limit of
 normal.

 -  Have an ECG performed that demonstrates sinus rhythm between 45 and 100 beats per
 minute (bpm), normal conduction, and no clinically significant arrhythmias.

 -  Be able to swallow whole tablets of OROS-MPH due to the controlled release
 formulation.

 -  If female, have a negative pregnancy test and agree to use one of the following
 methods of birth control, or be postmenopausal, have had a hysterectomy or have been
 sterilized. Birth control must be in effect starting at least 7 days (14 days for
 hormone-based methods used alone) prior to clinic intake, and should extend at least
 until the last follow-up visit.

 Exclusion Criteria:

 -  Please contact site for more information