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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
16
18 mg bid on days 1 and 2
27mg bid on days 3 and 4
35 mg bid on days 5-9
Cincinnati Addiction Research Center
Cincinnati, Ohio, United States
Ventana Clinical Research Corporation
Toronto, Ontario, Canada
Safety of the OROS-MPH concurrent with d-methamphetamine infusions.
Time frame: Daily
Plasma concentrations
Time frame: Screen, day 2, day 10
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