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

This study has been completed.

Study NCT00181714 Information provided by Massachusetts General Hospital

First Received on September 13, 2005. Last Updated on January 5, 2012 History of Changes

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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

Period 2: Began Treatment With OROS-MPH

Baseline Characteristics

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	14.3 ± 1.8
Gender [units: participants]
Female	40
Male	114
Region of Enrollment [units: participants]
United States	154

Outcome Measures

1. Primary:

Prevention of Cigarette Smoking [ Time Frame: 25.5 months ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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
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Results Point of Contact:

Name/Title: Paul Hammerness, MD
Organization: Massachusetts General Hospital
phone: 617-503-1040
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:	January 5, 2012
Health Authority:	United States: Institutional Review Board