255
Participants
Start Date
November 30, 2005
Primary Completion Date
January 31, 2008
Study Completion Date
March 31, 2008
Osmotic-Release Methylphenidate
OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
Placebo
OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
VA New York Harbor Healthcare System, New York
New York State Psychiatric Institute - Smoking Cessation Program, New York
Maryhaven, Inc., Columbus
Mayo Clinic Nicotine Research Program, Rochester
Kaiser Permanente (Center for Health Research), Portland
Massachusetts General Hospital, Cambridge
National Institute on Drug Abuse (NIDA)
NIH
Ortho-McNeil Janssen Scientific Affairs, LLC
INDUSTRY
University of Cincinnati
OTHER