Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta

Completed · Phase 4

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT00181714

Run by

Massachusetts General Hospital

People needed

203

Starts

2003-11-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-07

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adolescent outpatients between 12 to 17 years of age (inclusive).
• Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview.
• Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.

You may not qualify if…

• Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease.
• Clinically significant abnormal baseline laboratory values
• History of seizures
• Active tic disorder
• Pregnant or nursing females
• Mental retardation (intelligence quotient [IQ] < 75)
• Organic brain disorder
• Eating disorders
• Psychosis
• Current bipolar disorder (current episode)
• Current depression > mild (CGI-S > 3)
• Current anxiety > mild (CGI-S > 3)
• Substance abuse or dependence within the past 2 months
• Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (< 3 months)
• Recent change in benzodiazepines (< 3 months)
• Concerta non-responder

Where it is running

• Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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