NCT00603434

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Methamphetamine Dependence
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	OROS-MPH	18 mg bid on days 1 and 2
DRUG	OROS-MPH	27mg bid on days 3 and 4
DRUG	OROS-MPH	35 mg bid on days 5-9

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-01-29
• Last updated: 2017-01-12

Locations

2 sites across 2 countries: United States, Canada