PROTOCOL NIDA-CTN-0029


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

Eugene Somoza, MD, PhD
Theresa Winhusen, PhD
Co-Lead Investigators
University of Cincinnati/CinARC
somoza@uc.edu
winhusen@carc.uc.edu

The primary objective of this study was 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 involved 255 participants, recruited from six sites.
CTN-0029 Study Protocol

PRIMARY FINDINGS

Prolonged abstinence rates for the OROS-MPH and placebo groups did not differ significantly.  OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated.

Primary Outcomes Article: Winhusen TM, et al. Impact of Attention-Deficit/Hyperactivity Disorder (ADHD) Treatment on Smoking Cessation Intervention in ADHD Smokers: A Randomized, Double-Blind, Placebo-Controlled Trial. Journal of Clinical Psychiatry 2010;71(12):1680-1688. [get article]

RELATED RESOURCES

snowflake

Publications about CTN-0029

Study data from NIDA Data Share

ClinicalTrials.gov (NCT00253747)

NIDA protocol page


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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 2/2011 -- http://ctndisseminationlibrary.org/protocols/ctn0029.htm
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