Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
There are two specific aims of this study. The first is to document the pharmacokinetics of
dopamine transporter (DAT) receptor occupancy of repeated administration of orally
administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride
(IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography
(PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central
nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than
that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the
CNS DAT occupancy of the other two formulations will be intermediate.
The second aim 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.
Phase:
Phase 3
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.