• Prevention of cigarette smoking [ Time Frame: 25.5 months ] [ Designated as safety issue: No ]
  

Drug: methylphenidate HCl (Concerta)
For new subjects, study medication will be titrated up to 1.5 mg/kg/day to a target of 0.5-0.75 mg/kg/day in week one, 0.75-1.0 mg/kg/day by week-two, and 1.0-1.5 mg/kg/day daily by week three. Due to the availability of Concerta drug in increments of 9mg, study medication will be prescribed according to these parameters, or at the closest available lower dosage if clinically indicated. Those subjects entering the study on a stable and effective dose of Concerta (Clinical Global Impression Scale score of 1 or 2) will be allowed to remain on this dose or may be titrated in weekly increments of 0.25mg/kg to 0.5mg/kg if clinically indicated over the course of the study. For all subjects, doses will be titrated upward until the subject achieves a Clinical Global Impression Scale (CGI) score of 1 or 2. The maximum daily dose of Concerta will not exceed 126mg/kg/day. Doses will be adjusted downward if the subject develops side effects due to the medication.

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.