Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

Michael W Ogden, Kristin M Marano, Bobbette A Jones, Mitchell F Stiles, Michael W Ogden, Kristin M Marano, Bobbette A Jones, Mitchell F Stiles

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).

Keywords: Biomarkers; compliance; feasibility; health status measures; multi-center randomized study; risk continuum.

References

    1. American Thoracic Society (ATS). Lung function testing: selection of reference values and interpretative strategies. Am Rev Respir Dis. 1991;144:1202–18.
    1. Borgerding MF, Bodnar JA, Curtin GM, Swauger JE. The chemical composition of smokeless tobacco: a survey of products sold in the United States in 2006 and 2007. Regul Toxicol Pharmacol. 2012;64:367–87.
    1. Federal Trade Commission (FTC). Federal Register. 1967;32:11178. August 1.
    1. Federal Trade Commission (FTC). Federal Register. 1980;45:46483. July 10.
    1. Ferris BG. Epidemiology standardization project (American Thoracic Society). Am Rev Respir Dis. 1978;118:1–120.
    1. International Conference on Harmonization (ICH). 1996.
    1. King B, Dube S, Kaufmann R, et al. Vital signs: current cigarette smoking among adults aged ≥18 years – United States, 2005–2010. MMWR. 2011;60:1207–12.
    1. Nutt DJ, Phillips LD, Balfour D, et al. Estimating the harms of nicotine-containing products using the MCDA approach. Eur Addict Res. 2014;20:218–25.
    1. Ogden MW, Marano KM, Jones BA, et al. 2015a.
    1. Ogden MW, Marano KM, Jones BA, et al. 2015b.
    1. United States Congress. 2009.
    1. World Medical Association (WMA). 2002.
    1. Zeller M, Hatsukami D. Strategic Dialogue on Tobacco Harm Reduction Group The strategic dialogue on tobacco harm reduction: a vision and blueprint for action in the US. Tob Control. 2009;18:324–32.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir