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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. Identifier: NCT00181714
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 7, 2012
Last Update Posted : May 7, 2013
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
ADHD Drug: methylphenidate HCl (Concerta) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Cigarette Smoking in ADHD Youth With Concerta
Study Start Date : November 2003
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
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

Primary Outcome Measures :
  1. Cigarette Smoking [ Time Frame: 24 months ]
    Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181714

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United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
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Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital Identifier: NCT00181714    
Other Study ID Numbers: 2003-P-001313
First Posted: September 16, 2005    Key Record Dates
Results First Posted: February 7, 2012
Last Update Posted: May 7, 2013
Last Verified: May 2013
Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
cigarette smoking
Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents