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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00181714
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 7, 2012
Last Update Posted : May 7, 2013
Information provided by (Responsible Party):

September 13, 2005
September 16, 2005
January 5, 2012
February 7, 2012
May 7, 2013
November 2003
January 2011   (Final data collection date for primary outcome measure)
Cigarette Smoking [ Time Frame: 24 months ]
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Prevention of Cigarette Smoking
Complete list of historical versions of study NCT00181714 on ClinicalTrials.gov Archive Site
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Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Prevention of Cigarette Smoking in ADHD Youth With Concerta

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.

Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Drug: methylphenidate HCl (Concerta)
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.
Other Name: Concerta
Experimental: OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Intervention: Drug: methylphenidate HCl (Concerta)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP