Ogden Michael W, Marano Kristin M, Jones Bobbette A, Stiles Mitchell F
a RAI Services Company , Winston-Salem, NC , USA and.
b R.J. Reynolds Tobacco Company , Winston-Salem, NC , USA.
Biomarkers. 2015;20(6-7):382-90. doi: 10.3109/1354750X.2015.1094133. Epub 2015 Nov 2.
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).
开展了一项随机、多中心研究，以评估转向吸加热烟草制品、口含烟或超低机台产量燃烧烟草制品（每组50人）的成年现吸烟者在24周内健康状况指标的潜在改善情况，以及烟草暴露生物标志物和生物学效应生物标志物的变化。本文介绍了研究设计、实施过程和方法，以及受试者的处置情况、特征、依从性和安全性结果。这种在相对较短时间内评估一般健康成年吸烟者的设计和方法被证明是可行的。这项随机研究的结果提供了关于各种烟草制品风险连续体的普遍知识（ClinicalTrials.gov标识符：NCT02061917）。
