Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
ADHD
About this trial
This is an interventional prevention trial for ADHD focused on measuring cigarette smoking, ADHD, adolescents, Concerta
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Experimental
OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)