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

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Cigarette Smoking in ADHD Youth With Concerta

Conditions
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ADHD

Intervention / Treatment
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* Drug: methylphenidate HCl (Concerta)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OROS MPH<br>Single arm- open treatment with extended duration methylphenidate (OROS MPH) | Drug: methylphenidate HCl (Concerta)<br>* 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.<br>* Other names: Concerta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarette Smoking | Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette smoking, ADHD, adolescents, Concerta