title: Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology.
abstract: A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects' disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917).
authors.affiliation: a RAI Services Company , Winston-Salem, NC , USA and.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Ogden
authors.affiliation: a RAI Services Company , Winston-Salem, NC , USA and.
authors.forename: Kristin M
authors.initials: KM
authors.lastname: Marano
authors.affiliation: b R.J. Reynolds Tobacco Company , Winston-Salem, NC , USA.
authors.forename: Bobbette A
authors.initials: BA
authors.lastname: Jones
authors.affiliation: b R.J. Reynolds Tobacco Company , Winston-Salem, NC , USA.
authors.forename: Mitchell F
authors.initials: MF
authors.lastname: Stiles
mesh_terms: D000328:Adult; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000503:physiopathology; D012107:Research Design; D012129:Respiratory Function Tests; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires; D013997:Time Factors; D020340:Tobacco Use Cessation / Q000379:methods*; D061485:Tobacco Use Cessation Devices / Q000706:statistics & numerical data*; D014030:Tobacco, Smokeless / Q000706:statistics & numerical data*
keywords: Biomarkers; compliance; feasibility; health status measures; multi-center randomized study; risk continuum