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.

Trial registration: ClinicalTrials.gov identifier: NCT02061917.

• Biomarkers
• compliance
• feasibility
• health status measures
• multi-center randomized study
• risk continuum

Acknowledgements

The authors gratefully acknowledge Gary Dull, Summer Hanna, Thomas Steichen and Eugenia Theophilus.

Declaration of interest

All authors are current employees of RAI Services Company or R.J. Reynolds Tobacco Company.

Supplementary material available online

Supplementary Tables 1-3

Notes

¹Under the Family Smoking Prevention and Tobacco Control Act (United States Congress, 2009), the term “Ultra Lights” was banned as a cigarette descriptor as of 22 June 2010. However, this term is included in this report, as it accurately reflects the product descriptors in use at the time of the study.