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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Osmotic-Release Methylphenidate |
|
| 2 | Experimental | Osmotic-Release Methylphenidate |
|
| 3 | Experimental | Osmotic-Release Methylphenidate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS-MPH | Drug | 18 mg bid on days 1 and 2 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the OROS-MPH concurrent with d-methamphetamine infusions. | Daily |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | Screen, day 2, day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Somoza, MD, PhD | University of Cincinnati | Principal Investigator |
| Edward Sellers, MD, PhD | Ventana Clinical Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Addiction Research Center | Cincinnati | Ohio | 45220 | United States | ||
| Ventana Clinical Research Corporation |
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| OROS-MPH |
| Drug |
27mg bid on days 3 and 4 |
|
|
| OROS-MPH | Drug | 35 mg bid on days 5-9 |
|
|
| Toronto |
| Ontario |
| M5V2T3 |
| Canada |
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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