Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Methamphetamine; Methylphenidate

Criteria

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