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

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

Conditions
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Methamphetamine Dependence, Methamphetamine Abuse

Intervention / Treatment
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* Drug: OROS-MPH
* Drug: OROS-MPH
* Drug: OROS-MPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Osmotic-Release Methylphenidate | Drug: OROS-MPH<br>* 18 mg bid on days 1 and 2<br>* Other names: Concerta;|
| Experimental: 2<br>Osmotic-Release Methylphenidate | Drug: OROS-MPH<br>* 27mg bid on days 3 and 4<br>* Other names: Concerta;|
| Experimental: 3<br>Osmotic-Release Methylphenidate | Drug: OROS-MPH<br>* 35 mg bid on days 5-9<br>* Other names: Concerta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the OROS-MPH concurrent with d-methamphetamine infusions. |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations |  | Screen, day 2, day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine