NCT00253747

Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

Detailed description

The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 252 participants, recruited from approximately 6 sites.

Conditions

• ADHD
• Smoking

Interventions

Type	Name	Description
DRUG	Osmotic-Release Methylphenidate	OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
DRUG	Placebo	OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-01-01
• Completion: 2008-03-01
• First posted: 2005-11-15
• Last updated: 2012-09-17
• Results posted: 2012-09-17

Locations

6 sites across 1 country: United States