Health and economic impact analysis of a reduced nicotine cigarette policy on vulnerable populations - PROJECT SUMMARY/ABSTRACT The Food and Drug Administration (FDA) is considering a regulation that would reduce nicotine content in cigarettes to non-addictive levels. This could have profound implications for the health of the US population as cigarette smoking remains a leading cause of morbidity and mortality, and incurs nearly $170 billion in annual health care costs. An FDA analysis shows that a reduced nicotine cigarette policy could avert over 8 million premature deaths through 2100, but no study has evaluated its potential economic impact. It is also unknown how this policy could affect vulnerable populations, defined as groups at greater risk for poor health due to social factors or illness and disability. Clinical trials suggest that reduced nicotine cigarettes decrease smoking among vulnerable populations, but no study has evaluated their potential long-term implications. I plan to use simulation modeling methods to conduct health and economic impact analysis of a reduced nicotine cigarette policy for two vulnerable populations: 1) people with major depression, who continue to have higher smoking rates and less success with quitting compared to the general population; and 2) socioeconomically disadvantaged women of reproductive age, whose smoking increases risk for adverse maternal and infant health outcomes. I will extend a simulation model of smoking and depression that I previously developed to incorporate morbidity and economic outcomes, including direct medical costs and productivity losses. I will also develop a smoking model specific to women of reproductive age and level of educational attainment. This model will simulate smoking during pregnancy and its adverse effects on maternal and infant health, including premature delivery, low-birth-weight, small for gestational age, and sudden infant death syndrome. For both vulnerable populations, I will simulate the potential effects of e-cigarette use and an illicit market for normal nicotine cigarettes under a reduced nicotine cigarette policy. To be successful with this study and accurately assess the impact of the proposed regulation on costs to society, I need training in economic evaluation. I also need to deepen my understanding of the science of addiction and acquire background in reproductive health. To that end, I will enroll in formal coursework in cost- effectiveness analysis, addiction neurobiology, and reproductive health. I will also receive training from my team of mentors, who consist of NIH-funded investigators in tobacco regulatory science, health and economic modeling, behavioral pharmacology, and reproductive and mental health. At Yale, I will access a rich research environment through regular opportunities offered by the Tobacco Center of Regulatory Science, the Public Health Modeling Unit, and the Program in Addiction Medicine. This award will provide me with the skills and training I need to become a leading expert in health and economic modeling of addiction in vulnerable populations, and secure my path to career independence in tobacco regulatory science.