Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Cincinnati National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00603434 |
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.
Condition | Intervention | Phase |
---|---|---|
Methamphetamine Dependence Methamphetamine Abuse |
Drug: OROS-MPH |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH) |
Estimated Enrollment: | 16 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Osmotic-Release Methylphenidate
|
Drug: OROS-MPH
18 mg bid on days 1 and 2
|
2: Experimental
Osmotic-Release Methylphenidate
|
Drug: OROS-MPH
27mg bid on days 3 and 4
|
3: Experimental
Osmotic-Release Methylphenidate
|
Drug: OROS-MPH
35 mg bid on days 5-9
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eugene Somoza, M.D., Ph.D. | 513-487-7800 | somoza@uc.edu |
United States, Ohio | |
Cincinnati Addiction Research Center | Recruiting |
Cincinnati, Ohio, United States, 45220 | |
Contact: Eugene Somoza, MD, PhD 513-487-7800 somozae@email.uc.edu | |
Principal Investigator: Eugene Somoza, MD, PhD | |
Canada, Ontario | |
Ventana Clinical Research Corporation | Not yet recruiting |
Toronto, Ontario, Canada, M5V2T3 | |
Contact: Edward Sellers, MD, PhD 416-963-9338 ext 308 e.sellers@dlcrc.com | |
Principal Investigator: Edward Sellers, MD, PhD | |
Sub-Investigator: Myroslava Romach, MSc, MD |
Principal Investigator: | Eugene Somoza, MD, PhD | University of Cincinnati |
Principal Investigator: | Edward Sellers, MD, PhD | Ventana Clinical Research Corporation |
Responsible Party: | NIDA ( Liza Gorgon ) |
Study ID Numbers: | NIDA-CPU-Methylphenidate-0001 |
Study First Received: | January 16, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00603434 |
Health Authority: | United States: Food and Drug Administration |
Methamphetamine |
Methamphetamine Dopamine Methylphenidate Amphetamine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Adrenergic Uptake Inhibitors Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |