Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD.
The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prevention of Cigarette Smoking in ADHD Youth With Concerta|
- Cigarette Smoking [ Time Frame: 24 months ] [ Designated as safety issue: No ]Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
|Study Start Date:||November 2003|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Drug: methylphenidate HCl (Concerta)
OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
Other Name: Concerta
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181714
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|