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Completed

NCT Number: NCT00181714

Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Cigarette Smoking Mental Disorders Neurodevelopmental Disorders Smoking Tobacco Smoking Tobacco Use

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylphenidate HCl (Concerta)

Drug

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 names: Concerta

Primary outcomes

  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)

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Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

Registry information

Official study title

Prevention of Cigarette Smoking in ADHD Youth With Concerta

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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