Principal Investigator: Jennifer Tidey

Funding Mechanism: National Institutes of Health- TCORS Grant

ID number: 1P50DA036114-01

Award Date: 9/30/2013

Institution:  Brown University

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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. Studies to date have excluded vulnerable populations such as individuals with comorbid psychiatric illness, who may respond to reductions in the nicotine content of cigarettes with increases in psychiatric symptoms and/or with compensatory smoking. This project involves two studies that will evaluate relationships between the nicotine content of cigarettes and outcomes in smokers (aged 18-70) with major depressive disorder (MDD). Study 1, conducted in 60 subjects, will use a within-subjects design to compare effects of cigarettes varying in nicotine content on reinforcing efficacy, compensatory smoking, amelioration of abstinence-induced craving and withdrawal, and smoker preference for normal nicotine content (NNC) vs. reduced nicotine content (RNC) cigarettes under different cost conditions. Study 2, a randomized clinical trial including 400 subjects, will examine the effects of 12-week exposure to these cigarettes on smoking rate, nicotine dependence, depression severity, neurocognitive function, acceptability, and biomarkers of toxicant exposure and other health outcomes.  Specific aims are: (1) to compare the subjective and behavioral effects of cigarettes varying in nicotine content (0.80, 0.26, 0.12, 0.03 mg) in smokers with MDD; (2) to compare these cigarettes with regard to measures of use (e.g., cigarettes per day, total cotinine) and nicotine dependence severity in smokers with MDD over a 12-week exposure period; (3) to assess adherence to assigned tobacco products during the extended exposure study; (4) to quantify the effects of extended exposure on biomarkers of exposure to tobacco carcinogens (e.g., nitrosamine-4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL], polycyclic aromatic hydrocarbons [PAH] metabolites), markers of pulmonary and cardiovascular risk, depression symptoms, cognitive dysfunction and smoking topography; and (5) to compare the effects of these cigarettes on abstinence-induced craving, withdrawal, cigarette demand, and neurocognitive function in smokers with MDD. This study will provide new information about the effects a nicotine reduction policy may have on smokers with MDD.

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Vermont Center on Tobacco Regulatory Science (TCORS) Related Resources

• Vermont Center on Tobacco Regulatory Science (TCORS)
• Project 1: Low Nicotine Cigarettes in Vulnerable Populations: Childbearing Age Women
• Project 2: Low Nicotine Cigarettes in Vulnerable Populations: Opioid Abusers
• The original scientific abstract and other project information can be found on the NIH website