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

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).

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.

Inclusion Criteria:

• Clinical diagnosis of ADHD2
• Smoked cigarettes for at least 3 months
• Currently smoking > 10 cigarettes/day
• Have an interest in quitting
• Negative urine screen for cocaine, methamphetamine, opiates, benzodiazepines, and marijuana

Exclusion Criteria:

• Have a clinical diagnosis for current abuse or dependence for any psychoactive substance other than nicotine, depression, or anxiety; or a life-time clinical diagnosis of psychosis or bipolar disorder
• Allergic to OROS-MPH
• Pregnant or breastfeeding
• Abnormal electrocardiogram (ECG)
• Taking a Monoamine Oxidase (MAO) Inhibitor
• Taking any medication used for treating either ADHD or smoking
• Use of tobacco products other than cigarettes in the past week
• Blood pressure readings greater than 135/85 and/or a heart rate more than 90 beats per minute on three consecutive clinic visits