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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181714
First received: September 13, 2005
Last updated: May 2, 2013
Last verified: May 2013
Results First Received: January 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: ADHD
Intervention: Drug: methylphenidate HCl (Concerta)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OROS-Methylphenidate Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.

Participant Flow for 2 periods

Period 1:   Signed Consent/Enrolled
    OROS-Methylphenidate  
STARTED     203  
COMPLETED     154  
NOT COMPLETED     49  

Period 2:   Began Treatment With OROS-MPH
    OROS-Methylphenidate  
STARTED     154  
COMPLETED     30  
NOT COMPLETED     124  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OROS-Methylphenidate Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.

Baseline Measures
    OROS-Methylphenidate  
Number of Participants  
[units: participants]
  154  
Age  
[units: participants]
 
<=18 years     154  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.3  ± 1.8  
Gender  
[units: participants]
 
Female     40  
Male     114  
Region of Enrollment  
[units: participants]
 
United States     154  



  Outcome Measures

1.  Primary:   Cigarette Smoking   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitation of this report stems from its uncontrolled, open-label design. Thus, we cannot assert a causal relationship between lower smoking rates and OROS MPH prescription.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paul Hammerness, MD
Organization: Massachusetts General Hospital
phone: 617-503-1063
e-mail: phammerness@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:

Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181714     History of Changes
Other Study ID Numbers: 2003-P-001313
Study First Received: September 13, 2005
Results First Received: January 5, 2012
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board