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

University of Cincinnati

Status and phase: Completed; Phase 1

Conditions: Methamphetamine Dependence; Methamphetamine Abuse

Treatments: Drug: OROS-MPH

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00603434

NIDA-CPU-Methylphenidate-0001

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 3 patient groups

1

Experimental group

Description:

Osmotic-Release Methylphenidate

Treatment:

Drug: OROS-MPH

Drug: OROS-MPH

Drug: OROS-MPH

2

Experimental group

Description:

Osmotic-Release Methylphenidate

Treatment:

Drug: OROS-MPH

Drug: OROS-MPH

Drug: OROS-MPH

3

Experimental group

Description:

Osmotic-Release Methylphenidate

Treatment:

Drug: OROS-MPH

Drug: OROS-MPH

Drug: OROS-MPH