Cigarette smoking continues to be a major public health problem. Tobacco dependence
interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for
all smokers. A need exists for new medications to treat various aspects of tobacco
dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal
symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate
is similar to that of the reinforcing effects of nicotine. In a small previous study,
methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit
rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive
compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of
methylphenidate, is administered once a day, has similar bioavailability as the generic drug
administered 3 times a day and has an overall similar or improved efficacy compared to
generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized,
placebo-controlled phase II study assessing the effect of methylphenidate in cigarette
smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and
7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic
evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and
dependence will provide a wider choice of therapeutic agents to smokers wishing to become
abstinent from tobacco use.