The objective of this study is to evaluate whether 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 ADHD.

Condition	Intervention	Phase
ADHD Smoking	Drug: Methylphenidate (OROS-MPH)	Phase III

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcomes: Smoking abstinence
Secondary Outcomes: ADHD severity; Initial quit; Smoking withdrawal symptoms; Number of cigarettes per day; Use of non-cigarette tobacco products; Number of smoking days
Expected Total Enrollment:  252

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.

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00253747

Theresa Winhusen, Ph.D.      513-487-7802    Theresa.Winhusen@mdru.uc.edu
Emily DeGarmo      513-487-7803    Emily.DeGarmo@mdru.uc.edu

Massachusetts
      Massachusetts General Hospital, Cambridge,  Massachusetts,  02138,  United States
Minnesota
      Mayo Clinic Nicotine Research Program, Rochester,  Minnesota,  55901,  United States
Ohio
      Maryhaven, Inc., Columbus,  Ohio,  43207,  United States

Study chairs or principal investigators

Eugene Somoza, M.D., Ph.D.,  Principal Investigator,  University of Cincinnati   
Theresa Winhusen, Ph.D.,  Principal Investigator,  University of Cincinnati   

Study ID Numbers:  NIDA-CTN-0029
Last Updated:  December 13, 2005
Record first received:  November 13, 2005
ClinicalTrials.gov Identifier:  NCT00253747
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10