Principal Investigator: Wallace Bruce Pickworth
Funding Mechanism: National Institutes of Health- Grant
ID number: 1R01CA158045-01A1
Award Date: 9/10/2012
Institution: Battelle Centers/Public Health Research and Evaluation
Despite evidence suggesting that cigar smoke delivers nicotine and more than 60 carcinogens, there are no systematic studies that consider both the use patterns and toxin delivery of various cigar products. Using a clinical study design, investigators will compare cigarettes to three prototypical cigar products (i.e., cigarillo, small cigar and conventional cigar) to examine behavioral aspects of smoking. The study team will also examine the chemistry and particle distribution of the products’ mainstream smoke. The goal is to characterize the behavioral and physiological differences between cigar and cigarette smoking and subsequent toxin exposure. Study aims are: (1) to determine the range of immediate and chronic toxin exposure and smoking behavior associated with cigars and cigarettes; and (2) to comprehensively characterize particle size distribution and content of selected carcinogens and other compounds in machine-generated mainstream smoke. In the clinical study, 75 adult subjects of either gender and any racial/ethnic background who smoke both cigarettes and cigars will be assigned to one of three experimental groups (cigarillo, small cigar, conventional cigar; 25 subjects per group), based on their usual cigar product. Puff topography and inhalation measures will be collected simultaneously while the subjects smoke the cigar (at one visit) and their own brand cigarette (at a second visit); puff and inhalation measures will distinguish smoking patterns between cigars (generally thought not to be inhaled) and cigarettes (almost always inhaled). Chemical measures of acute (nicotine and carbon monoxide boost) and chronic (cotinine and 3-OH-cotinine NNAL, 1-HOP) exposure will be obtained from the participants. The chemical laboratory study will assess the particle size (fine and ultra fine) distribution and gas-phase toxic/carcinogenic components in mainstream smoke from the cigars and cigarettes. Investigators will analyze mainstream smoke generated with a smoking machine based on the puff profiles of the clinical study participants. In addition, investigators will analyze mainstream smoke generated from standardized puff protocols (ISO/FTC37 and ICCSS36) such that each puff (volume, velocity and duration and the inter-puff interval) is identical; both protocols will be used to test the cigars and five representative cigarettes (full flavor, light, ultra light, unfiltered and menthol). This study will provide information about the addictive and health risks of cigar smoking and may inform regulatory decisions related to cigar products.