Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
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|ClinicalTrials.gov Identifier: NCT00181714|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 7, 2012
Last Update Posted : May 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: methylphenidate HCl (Concerta)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Cigarette Smoking in ADHD Youth With Concerta|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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
- Cigarette Smoking [ Time Frame: 24 months ]Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181714
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|