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Cancer Center Support Grant: Effects of Very Low Nicotine Content Cigarettes on Intermittent Smokers

Principal Investigator: Nancy Davidson

Funding Mechanism:  Intra-Departmental Delegation of Authority (IDDA)

ID Number: 3P30CA047904-25S4

Award Date:  5/7/2014

Institution:  University of Pittsburgh Cancer Institute 

Reduced nicotine content cigarettes have the potential to mitigate addiction and the appeal of smoking, thereby reducing cigarette use. Initial studies involving use of very low nicotine content cigarettes (VLNCCs) by daily/heavy smokers have been conducted; although these smokers might potentially escalate smoking in order to avoid nicotine withdrawal symptoms, these studies suggest that increased smoking does not occur in response to lower nicotine content. However, it is not clear whether these findings apply to the large population of non-daily (intermittent) smokers. The goal of this study is to assess the effects of VLNCC use among intermittent smokers. After a two-week baseline period of smoking their own cigarettes, 455 intermittent smokers aged 21 and older will be randomized to smoke one of two types of experimental cigarettes for ten weeks: normal nicotine content cigarettes (NNCCs; 0.8 mg per cigarette) or VLNCCs (0.07 mg per cigarette), matched to the menthol status of subjects' preferred brand. Specific aims are: (1) to assess cigarette consumption changes between smoking own cigarettes and smoking VLNCCs or NNCCs; and (2) to assess changes in per-cigarette smoking intensity, measured by the two smoking biomarkers cotinine and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), solanesol (a stable marker assayed in cigarette butts), butt weight and length, and smoking topography measures. Investigators will also evaluate individual differences that could moderate response to VLNCCs, including ethnicity (African-Americans vs. white smokers), history of past daily smoking, and starting level of dependence, and will assess changes in smoking behaviors and temporal smoking patterns. Findings from this study may inform the regulation of nicotine levels in cigarettes.

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