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Randomized Controlled Trial
. 2022 Nov 30;12(1):20658.
doi: 10.1038/s41598-022-25054-z.

Part three: a randomized study to assess biomarker changes in cigarette smokers switched to Vuse Solo or Abstinence

Milly N Kanobe  1 , Bobbette A Jones  2 , Paul Nelson  2 , Buddy G Brown  2 , Peter Chen  2 , Patrudu Makena  2 , Eckhardt Schmidt  2 , John Darnell  2 , John W Caraway  2 , G L Prasad  2   3 , Brian Nordskog  4 , Elaine K Round  2
Affiliations
Randomized Controlled Trial

Part three: a randomized study to assess biomarker changes in cigarette smokers switched to Vuse Solo or Abstinence

Milly N Kanobe et al. Sci Rep. .

Abstract

Biomarkers of exposure (BoE) can help evaluate exposure to combustion-related, tobacco-specific toxicants after smokers switch from cigarettes to potentially less-harmful products like electronic nicotine delivery systems (ENDS). This paper reports data for one (Vuse Solo Original) of three products evaluated in a randomized, controlled, confinement study of BoE in smokers switched to ENDS. Subjects smoked their usual brand cigarette ad libitum for two days, then were randomized to one of three ENDS for a 7-day ad libitum use period, or to smoking abstinence. Thirteen BoE were assessed at baseline and Day 5, and percent change in mean values for each BoE was calculated. Biomarkers of potential harm (BoPH) linked to oxidative stress, platelet activation, and inflammation were also assessed. Levels decreased among subjects randomized to Vuse Solo versus Abstinence, respectively, for the following BoE: 42-96% versus 52-97% (non-nicotine constituents); 51% versus 55% (blood carboxyhemoglobin); and 29% versus 96% (nicotine exposure). Significant decreases were observed in three BoPH: leukotriene E4, 11-dehydro-thromboxane B2, and 2,3-dinor thromboxane B2 on Day 7 in the Vuse Solo and Abstinence groups. These findings show that ENDS use results in substantially reduced exposure to toxicants compared to smoking, which may lead to reduced biological effects.

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Conflict of interest statement

M.K., P.C., J.D., P.M., E.R., J.W.C., and E.S. are full-time employees of RAI Services Company, and B.G.B., B.A.J., G.L.P., and P.N. are former full-time employees of RAI Services Company. RAI Services Company and R.J. Reynolds Tobacco Company are wholly owned subsidiaries of Reynolds American Inc., which is a wholly owned subsidiary of British American Tobacco plc. G.L.P. is an independent consultant. B.N. is a full-time employee of JTI Leaf Services (US) LLC.

Figures

Figure 1
Figure 1
Mean percent change from baseline in constituent biomarkers of exposure in smokers switched to Vuse Solo or Abstinence for 5 days. 1-AN (1-aminonaphthaline; ng/24 h); 2-AN (2-aminonaphthalene; ng/24 h); 4-ABP (4-aminobiphenyl; ng/24 h); o-Tol (o-Toluidine; ng/24 h); Acrylonitrile (2-cyanoethyl mercapturic acid [CEMA]; µg/24 h); Crotonaldehyde (3-hydroxy-1-methylpropylmercapturic acid [HMPMA]; µg/24 h); Acrolein (3-hydroxypropyl mercapturic acid [HPMA]; µg/24 h); 1,3-Butadiene (Monohydroxybutenyl mercapturic acid [MHBMA]; µg/24 h); Benzene (S-phenyl mercapturic acid [SPMA]; µg/24 h); B[a]P (3-hydroxy-benzo[a]pyrene; pg/24 h); NNK: (Nicotine-derived nitrosamine ketone; 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol + glucuronides [Total NNAL]); NNN (N-nitrosonornicotine; N’-nitrosonornicotine + glucuronides [Total NNN]; ng/24 h); COHb: carboxyhemoglobin (%); NicEq-T: Nicotine ([Total Nicotine Equivalents]; ng/24 h); all changes from baseline to Day 5 were statistically significant, with the exception of NNN in the Abstinence group due to one extreme data value.
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