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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00302458 |
Purpose
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 |
|---|---|---|
|
Healthy |
Drug: OROS methylphenidate HCl Drug: immediate release methylphenidate HCl Drug: Placebo Capsule |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IR-MPH
Immediate Release Methylphenidate Hydrochloride
|
Drug: immediate release methylphenidate HCl
Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules
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Active Comparator: Concerta
Long acting MPH
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Drug: OROS methylphenidate HCl
Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules
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Placebo Comparator: overencapsulated placebo capsule
Each dose of placebo will be two overencapsulated placebo capsules.
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Drug: Placebo Capsule
Each dose of placebo will be two overencapsulated placebo capsules.
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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, the investigators 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:
The investigators 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| Principal Investigator: | Thomas Spencer, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Thomas Spencer, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00302458 History of Changes |
| Other Study ID Numbers: | 2005-P-001812 |
| Study First Received: | March 13, 2006 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
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healthy volunteers |
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Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |