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

被引：16

作者：

Ogden, Michael W. ^{[1
]}

Marano, Kristin M. ^{[1
]}

Jones, Bobbette A. ^{[2
]}

Stiles, Mitchell F. ^{[2
]}

机构：

[1] RAI Serv Co, Winston Salem, NC 27102 USA

[2] RJ Reynolds Tobacco Co, Winston Salem, NC USA

来源：

BIOMARKERS | 2015年 / 20卷 / 6-7期

关键词：

Biomarkers; compliance; feasibility; health status measures; multi-center randomized study; risk continuum; UNITED-STATES;

D O I：

10.3109/1354750X.2015.1094133

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

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).

引用

页码：382 / 390

页数：9

共 13 条

[1]

American Thoracic Society (ATS), 1991, AM REV RESPIR DIS, V144, P1202

[2] The chemical composition of smokeless tobacco: A survey of products sold in the United States in 2006 and 2007 [J].

Borgerding, M. F. ;

Bodnar, J. A. ;

Curtin, G. M. ;

Swauger, J. E. .

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2012, 64 (03) :367-387

[3]

Federal Trade Commission (FTC), 1980, FED REGISTER, V45, P46483

[4]

Federal Trade Commission (FTC), 1967, FED REGISTER, V32, P11178

[5]

FERRIS BG, 1978, AM REV RESPIR DIS, V118, P1

[6]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 1996, GUID IND E6 GOOD CLI

[7]

King Brian, 2011, Morbidity and Mortality Weekly Report, V60, P1207

[8] Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach [J].