Phase 4
Completed N=203
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Source: ClinicalTrials.gov NCT00181714 ↗Enrolled (actual)
203
Serious AEs
3.3%
Results posted
Feb 2012
Primary outcomePrimary: Cigarette Smoking — 7 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Smoking |
7 | — |
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] 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
Data sourced from ClinicalTrials.gov (NCT00181714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.