Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/13/2017 |
| Start Date: | January 2008 |
| End Date: | March 2009 |
Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous 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.
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
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