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UVM TCORS Project 4: Low Nicotine Content Cigarettes in Vulnerable Populations: Pregnant Women

Principal Investigator(s): Sarah H. Heil

Funding Mechanism: National Institutes of Health – TCORS Grant

ID number: 2 U54 DA036114-06

Award Date: 8/31/18

Institution: University of Vermont and State Agricultural College

Approximately 11% of U.S. women (~17 million women) are smokers when they become pregnant, with prevalence as high as 40% among socioeconomically disadvantaged women. Smoking during pregnancy can cause catastrophic pregnancy complications and adverse effects on fetal development that a growing body of evidence suggests can compromise health throughout the lifespan. Researchers are currently conducting a multi-site study examining the acute effects of very low nicotine content cigarettes (VLNCCs) on the addiction potential of smoking in pregnant women; the goal of this project is to further this line of research by examining extended exposure. Study aims are: (1) to compare extended exposure to either usual brand cigarettes or VLNCCs on number of cigarettes smoked per day; (2) to quantify the effects of extended exposure to VLNCCs on measures of biomarkers of exposure (total cotinine, NNAL, PAH) and sonographic assessments of fetal growth and body composition; and (3) to compare the effects of VLNCCs on abstinence-induced cigarette demand, craving, and withdrawal. It should be noted that a recommendation to all women screened for this study will be that they should quit, consistent with ethical guidelines about smoking during pregnancy. All potential participants will be asked at screening about their intentions to quit smoking during pregnancy. Those with intentions to quit in the next 12 weeks will be referred to our ongoing studies on smoking cessation in pregnant women. Those who do not will be randomized to smoke either usual brand cigarettes or VLNCCs for 12 weeks. Ninety participants (ages 18-44) will complete two in-person baseline assessments (involving baseline health and smoking assessments, a variety of questionnaires, biomarker assessments, and fetal measurements) and will be seen weekly throughout the study. Findings may inform regulatory activities related to reduced-nicotine cigarettes.

UVM TCORS: University of Vermont Tobacco Center of Regulatory Science Related Resources

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