Clinical trial NCT00181714: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Keywords: cigarette smoking
ADHD
adolescents
Concerta
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2005-09-16
Enrollment: 203
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Cigarette Smoking
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.