Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
1 other identifier
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
February 7, 2012
CompletedMay 7, 2013
May 1, 2013
7.2 years
September 13, 2005
January 5, 2012
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cigarette Smoking
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
24 months
Study Arms (1)
OROS MPH
EXPERIMENTALSingle arm- open treatment with extended duration methylphenidate (OROS MPH)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Related Publications (3)
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.
PMID: 23639146DERIVEDHammerness 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.
PMID: 21143432DERIVEDHammerness 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.
PMID: 19394037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Paul Hammerness, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Biederman, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
November 1, 2003
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 7, 2013
Results First Posted
February 7, 2012
Record last verified: 2013-05