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Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta - NCT00181714-02138(Clinical Trial 129172)



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City:  Cambridge
State:  
MA
Zip Code: 02138
Conditions: ADHD
Purpose: This study will consist of a six-week open-label treatment period with Concerta followed by subsequent monthly visits for 24 months in 150 youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD. The researchers hypothesize that Concerta treatment will reduce initiation, dose, and dependence of cigarette smoking compared to community controls and Concerta treatment will be associated with a lower rate of smoking compared to public population statistics of smoking.
Study summary: The goal of our study is to follow-up on our pilot study results, which suggest that aggressive treatment with methylphenidate TID prevents smoking in ADHD youth. This study will determine if these findings will generalize to aggressive treatment with Concerta. We propose to determine if the treatment of Concerta in 150 ADHD adolescents reduces the frequency of smoking and nicotine dependence. Although we expect that the one year duration of the study will provide preliminary evidence for the ability of Concerta to prevent the initiation of regular smoking and nicotine dependence, we recognize that following these adolescents for a longer period of time will answer a key question about the ultimate effectiveness of our approach: whether it will lead to sustained abstinence from cigarette smoking and, considering that cigarette smoking is frequently the first step toward the abuse of alcohol and drugs, whether Concerta treatment will lead to a reduction of these substance abuse outcomes as well. Thus, we have planned our work so that it will be feasible to collect long-term follow-up data should that be warranted from the initial results. This study includes use of a two-year open-label treatment design to document the primary outcome measure of cigarette smoking and secondary outcome measures of psychopathology, functioning, and adverse experiences.
Criteria: Inclusion Criteria: 1. Adolescent outpatients between 12 to 17 years of age (inclusive). 2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview. 3. 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: 1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease. 2. Clinically significant abnormal baseline laboratory values 3. History of seizures 4. Active tic disorder 5. Pregnant or nursing females 6. Mental retardation (intelligence quotient [IQ] < 75) 7. Organic brain disorder 8. Eating disorders 9. Psychosis 10. Current bipolar disorder (current episode) 11. Current depression > mild (CGI-S > 3) 12. Current anxiety > mild (CGI-S > 3) 13. Substance abuse or dependence within the past 2 months 14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (< 3 months) 15. Recent change in benzodiazepines (< 3 months) 16. Concerta non-responder
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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