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Evaluating New Reduced Nicotine Standards for Cigarettes

Principal Investigator: Eric C. Donny

Funding Mechanism: National Institutes of Health- Grant

ID number: 1U54 DA031659-01

Award Date: 9/15/2011

Institution: University of Pittsburgh at Pittsburgh

Reduction in nicotine content has been proposed as a potential regulatory measure to render cigarettes non-addictive and, consequently, to reduce smoke exposure and improve public health. The goal of this research effort is to determine how a marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers. This five-year research effort involves four interrelated projects. Project 1, a multisite trial, includes two human studies evaluating the dose-response relationship for nicotine yield within the range thought to be at or below threshold for dependence and the potential use of concurrent nicotine replacement therapy (NRT) to facilitate the transition to very low nicotine content (VLNC) cigarettes; study subjects include 1,080 daily smokers aged 18 and older. Project 2, a multi-site trial involving 1,250 subjects, assesses the effects of prolonged VLNC use and compares an immediate switch to VLNC cigarettes with a gradual reduction in cigarette nicotine content over 20 weeks. Project 3 focuses on the impact of VLNC cigarettes on smokers with schizophrenia; this project begins to address an important concern about the impact of a new nicotine content standard in smoker sub-populations who might be particularly vulnerable to the effects of nicotine reduction. Project 4 addresses concerns that the manipulation of other tobacco constituents could offset the predicted gains of VLNC cigarettes by investigating the relationship between the threshold dose for maintaining rat nicotine self-administration and the presence of minor alkaloids, beta-carbolines, acetaldehyde, and monoamine oxidase inhibitors (MAOIs). These four projects will reveal important information about whether establishing new lower nicotine standards for cigarettes would reduce cigarette use and, consequently, reduce the morbidity and mortality associated with smoking.

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