UVM TCORS: Low Nicotine Content Cigarettes in Vulnerable Populations: Childbearing Age Women

Principal Investigator: Sarah Heil and Stephen Higgins

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036114-01

Award Date: 9/30/2013

Institution: University of Vermont

Reducing the nicotine content of cigarettes has shown promising beneficial effects (e.g., decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population, but studies have excluded vulnerable populations such as low-income pregnant women, who may respond differently due to greater vulnerability to smoking and nicotine dependence. This project involves two studies that will evaluate how pregnant and non-pregnant smokers aged 18-44 might respond to reduced nicotine content (RNC) cigarettes. In Study 1, investigators will assess the effects of brief exposure to cigarettes of varying nicotine yield (0.80, 0.26, 0.12, 0.03 mg in 60 non-pregnant women; usual brand, 0.10, 0.03 mg in 60 pregnant women) on craving, nicotine withdrawal, and the degree to which the RNC cigarettes substitute for typical nicotine content cigarettes in behavioral-economic tests of smoking preference. In Study 2, 400 non-pregnant and 200 pregnant smokers will be randomized to smoke one of the above doses during an extended exposure phase (12 weeks in non-pregnant women; through delivery in pregnant women). Specific aims are: (1) to compare the subjective and behavioral effects of cigarettes varying in nicotine content in non-pregnant and pregnant women; (2) to compare extended exposure to these cigarettes on measures of smoking rate (cigarettes per day, urine cotinine levels) and nicotine dependence severity in non-pregnant and pregnant women; (3) to assess adherence to assigned tobacco products during the extended exposure study; (4) to quantify the effects of extended exposure to RNC cigarettes on biomarkers of exposure (e.g., total cotinine, nitrosamine-4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL], polycyclic aromatic hydrocarbons [PAH]), markers of thrombotic risk and lung function, and sonographic estimates of fetal growth and birth outcomes; and (5) to compare the effects of these cigarettes on abstinence-induced craving, withdrawal, cigarette demand, and neurocognitive function in non-pregnant and pregnant women. This project will provide new information about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy.

U.S. Food and Drug Administration

UVM TCORS: Low Nicotine Content Cigarettes in Vulnerable Populations: Childbearing Age Women

Vermont Center on Tobacco Regulatory Science (TCORS) Related Resources