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Sponsors and Collaborators: |
Massachusetts General Hospital McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00302458 |
This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows:
Condition | Intervention | Phase |
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Healthy |
Drug: OROS methylphenidate HCl Drug: immediate release methylphenidate HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Crossover Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults |
Estimated Enrollment: | 20 |
Study Start Date: | January 2006 |
The main goal of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release. To this end, we will compare repeated administration of orally administered, therapeutic doses of a short (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) in the following areas:
We will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; OROS-MPH to OROS-MPH, and placebo to placebo.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Males or non-pregnant, non-lactating females. With the exception of women who have been post-menopausal for a minimum of 12 months prior to screening and those who have undergone hysterectomy or bilateral oophorectomy, all female subjects must have a negative urine pregnancy test at both screening and at each admission to the research unit. All male and female subjects must have used a medically acceptable form of birth control for at least one month prior to screening and be willing to continue use during the study.
Medically acceptable forms of birth control include abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, intrauterine device, or surgical sterilization (including vasectomy of male partner[s]).
Exclusion Criteria:
Scores of Baseline Scales:
Clinically significant abnormal baseline laboratory values which include the following:
Currently taking or require any of the following medications:
Contact: Meghan Dougherty, BS | 617-503-1051 | mdougherty2@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 | |
Principal Investigator: Thomas Spencer, MD |
Principal Investigator: | Thomas Spencer, MD | Massachusetts General Hospital |
Study ID Numbers: | 2005-P-001812 |
Study First Received: | March 13, 2006 |
Last Updated: | August 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00302458 History of Changes |
Health Authority: | United States: Institutional Review Board |
healthy volunteers |
Dopamine Uptake Inhibitors Neurotransmitter Agents Dopamine Methylphenidate |
Central Nervous System Stimulants Dopamine Agents Healthy |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Methylphenidate Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |