Efficacy of Methylphenidate for treating tobacco dependence

  • Hurt, Richard D, (PI)

Project: Research project

Description

DESCRIPTION (provided by applicant): After a steady decline for the last 50 years, the prevalence of cigarette smoking in the U.S. has reached a plateau of approximately 23%. Currently available treatments are not efficacious for all tobacco users. Thus, new pharmacologic agents need to be investigated to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved tobacco dependence treatment medication acts by central nervous system (CNS) dopamine and norepinephrine reuptake inhibition and through a direct inhibition of the nicotinic acetylcholine receptor. Methylphenidate, a CNS stimulant, blocks the reuptake of dopamine, serotonin and nor-epinephrine, and has a similar neurobiologic effect as nicotine. In a pilot study, methylphenidate was reported to improve symptoms of nicotine withdrawal. Thus, methylphenidate is likely to be efficacious for treating tobacco dependence rates in smokers who are attempting to stop smoking. Methylphenidate is generally well tolerated and has a low potential for abuse when used for the short term. We propose to evaluate the efficacy of an 8-week course of long acting methylphenidate (ConcertaTM) at a dose of 54-mg per day, for producing better biochemically-confirmed 7-day point prevalence tobacco abstinence rates at end of treatment compared to placebo. The study is designed as a randomized, doubleblind placebo-controlled phase II pilot study and we propose to enroll 80 smokers. If the results from this preliminary study support the performance of a larger clinical trial, then a future grant application will be submitted through the R01 research project grant mechanism.
StatusFinished
Effective start/end date9/30/069/30/09

Funding

  • National Institutes of Health: $250,095.00
  • National Institutes of Health: $148,900.00

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Tobacco Use Disorder
Methylphenidate
Organized Financing
Nicotine
Tobacco
Dopamine
Smoking
Healthy People Programs
Placebos
Bupropion
Substance Withdrawal Syndrome
Nicotinic Receptors
Tobacco Use
Epinephrine
Serotonin
Norepinephrine
Therapeutics
Central Nervous System
Clinical Trials
Central Nervous System Stimulants

ASJC

  • Medicine(all)