Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: methylphenidate HCl (Concerta) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Paul Hammerness, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Meghan Kotarski, MBA, Phone: 617-503-1051, Email: mkotarski@partners.org
Summary
This study will consist of a six-week open-label treatment period with Concerta followed by
subsequent monthly visits for 24 months in 150 youths aged 12-17 who meet Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD. The
researchers hypothesize that Concerta treatment will reduce initiation, dose, and dependence
of cigarette smoking compared to community controls and Concerta treatment will be
associated with a lower rate of smoking compared to public population statistics of smoking.
Clinical Details
Official title: Prevention of Cigarette Smoking in ADHD Youth With Concerta
Study design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Primary outcome: Prevention of cigarette smoking
Detailed description:
The goal of our study is to follow-up on our pilot study results, which suggest that
aggressive treatment with methylphenidate TID prevents smoking in ADHD youth. This study
will determine if these findings will generalize to aggressive treatment with Concerta. We
propose to determine if the treatment of Concerta in 150 ADHD adolescents reduces the
frequency of smoking and nicotine dependence. Although we expect that the one year duration
of the study will provide preliminary evidence for the ability of Concerta to prevent the
initiation of regular smoking and nicotine dependence, we recognize that following these
adolescents for a longer period of time will answer a key question about the ultimate
effectiveness of our approach: whether it will lead to sustained abstinence from cigarette
smoking and, considering that cigarette smoking is frequently the first step toward the
abuse of alcohol and drugs, whether Concerta treatment will lead to a reduction of these
substance abuse outcomes as well. Thus, we have planned our work so that it will be
feasible to collect long-term follow-up data should that be warranted from the initial
results.
This study includes use of a two-year open-label treatment design to document the primary
outcome measure of cigarette smoking and secondary outcome measures of psychopathology,
functioning, and adverse experiences.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Meghan Kotarski, MBA, Phone: 617-503-1051, Email: mkotarski@partners.org
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States; Recruiting
Meghan Kotarski, MBA, Phone: 617-503-1051, Email: mkotarski@partners.org
Courtney Williams, BA, Phone: 617-503-1089, Email: cgwilliams@partners.org
Paul Hammerness, MD, Principal Investigator
Additional Information
Starting date: November 2003
Last updated: July 13, 2009
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