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

ADHD Clinical Trial

Official title:

Prevention of Cigarette Smoking in ADHD Youth With Concerta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181714
• Other study ID #: 2003-P-001313
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 2, 2013
• Start date: November 2003
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• methylphenidate HCl (Concerta)
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Smoking	Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)	24 months	No