Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 5: 8-Day randomized clinical trial in Japan

Regul Toxicol Pharmacol. 2012 Nov 1;64(2 Suppl):S54-63. doi: 10.1016/j.yrtph.2012.08.003. Epub 2012 Aug 23.


A randomized, controlled, open-label, parallel-group, single-center study to determine biomarkers of exposure to twelve selected harmful and potentially harmful constituents (HPHCs) in cigarette smoke and urinary excretion of mutagenic material in 128 male and female Japanese subjects smoking Marlboro cigarettes (6 mg tar, 0.5mg nicotine, and 7.0mg CO) at baseline. Subjects were randomized to continue smoking Marlboro cigarettes, or switch to the Electrically Heated Cigarette Smoking System (EHCSS) and smoke either the EHCSS-K6 (5mg tar, 0.3mg nicotine, and 0.6 mg CO) or the EHCSS-K3 (3mg tar, 0.2mg nicotine, and 0.6 mg CO) cigarette, or switch to smoking Lark One cigarettes (1mg tar, 0.1mg nicotine, and 2.0mg CO), or to no-smoking. The mean decreases from baseline to Day 8 were statistically significant (p ≤ 0.05) for all cigarette smoke HPHC including CO (the primary objective) and excretion of mutagenic material in the EHCSS-K6 (range: -14.6% to -75.6%) and EHCSS-K3 (range: -9.8% to -73.0%) groups. Statistically significant reductions (all p ≤ 0.05) in exposure to ten cigarette smoke HPHC (range: -5.9% to -34.6%), but not urinary mutagenicity, were observed in the Lark One group. The largest mean reductions in exposure to HPHC (all p ≤ 0.01 level) occurred in the no-smoking group (range: -13.7% to -97.6%).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomarkers / blood
  • Biomarkers / urine
  • Carboxyhemoglobin / analysis
  • Electricity
  • Female
  • Hot Temperature
  • Humans
  • Inhalation Exposure / adverse effects*
  • Inhalation Exposure / analysis
  • Japan
  • Male
  • Middle Aged
  • Smoking / adverse effects
  • Smoking / blood*
  • Smoking / urine*
  • Time Factors
  • Tobacco / chemistry
  • Tobacco / metabolism*
  • Tobacco / toxicity
  • Tobacco Products / analysis*
  • Tobacco Products / toxicity
  • Tobacco Smoke Pollution / adverse effects
  • Tobacco Smoke Pollution / analysis*
  • Tobacco Smoke Pollution / prevention & control
  • Young Adult


  • Biomarkers
  • Tobacco Smoke Pollution
  • Carboxyhemoglobin