Trial Information

Summary: Prevention of Cigarette Smoking in ADHD Youth with Concerta

Since there is preliminary evidence which suggests that ADHD youth are at a greater risk for smoking than non-ADHD youth, the purpose of this research study is to examine the effect of Concerta as treatment for ADHD on the likelihood of smoking in adolescents. Participation in the research study consists of an evaluation process, including an evaluation by a clinician, physical exams, cognitive (thinking processes) testing, a structured interview and blood/urine tests, 6 weekly visits with the clinician for 30-45 minutes, and, for those who are judged to be responders to Concerta, 2 years of monthly visits (once a month) for about an hour. At these visits, participants will meet with the study clinician, have their vitals signs taken, complete some forms, and provide urine and/or blood samples. Eligible participants will be compensated $50 per completed visit.

Eligibility Criteria:
Male or female, 12-17 years of age. Parent or legal guardian must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. Subjects and their legal guardian must be considered reliable. Each subject and his/her authorized legal guardian must understand the nature of the study. The subject's authorized legal guardian must sign an informed consent document and the subject must sign an assent document. Subject must have a diagnosis of Attention Deficit Hyperactivity Disorder and currently display significant symptoms warranting treatment based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders). The subject may be a smoker or a non-smoker. Subjects currently taking an effective dose of Concerta are eligible for participation, but subjects who have not responded to Concerta in the past will be excluded. Subjects with chronic medical illness and those who have exhibited symptoms of severe bipolar disorder, depression or anxiety within the past three months will be excluded.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.