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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
methylphenidate HCl (Concerta)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ADHD focused on measuring cigarette smoking, ADHD, adolescents, Concerta

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OROS MPH

Arm Description

Single arm- open treatment with extended duration methylphenidate (OROS MPH)

Outcomes

Primary Outcome Measures

Cigarette Smoking
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 2, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00181714
Brief Title
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Official Title
Prevention of Cigarette Smoking in ADHD Youth With Concerta
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
cigarette smoking, ADHD, adolescents, Concerta

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OROS MPH
Arm Type
Experimental
Arm Description
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Intervention Type
Drug
Intervention Name(s)
methylphenidate HCl (Concerta)
Other Intervention Name(s)
Concerta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cigarette Smoking
Description
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23639146
Citation
Hammerness P, Fried R, Petty C, Meller B, Biederman J. Assessment of cognitive domains during treatment with OROS methylphenidate in adolescents with ADHD. Child Neuropsychol. 2014;20(3):319-27. doi: 10.1080/09297049.2013.790359. Epub 2013 May 2.
Results Reference
derived
PubMed Identifier
21143432
Citation
Hammerness P, Biederman J, Petty C, Henin A, Moore CM. Brain biochemical effects of methylphenidate treatment using proton magnetic spectroscopy in youth with attention-deficit hyperactivity disorder: a controlled pilot study. CNS Neurosci Ther. 2012 Jan;18(1):34-40. doi: 10.1111/j.1755-5949.2010.00226.x. Epub 2010 Dec 8.
Results Reference
derived
PubMed Identifier
19394037
Citation
Hammerness P, Wilens T, Mick E, Spencer T, Doyle R, McCreary M, Becker J, Biederman J. Cardiovascular effects of longer-term, high-dose OROS methylphenidate in adolescents with attention deficit hyperactivity disorder. J Pediatr. 2009 Jul;155(1):84-9, 89.e1. doi: 10.1016/j.jpeds.2009.02.008. Epub 2009 Apr 25.
Results Reference
derived

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

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