Abstract
IntroductionThis study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers.Aims and MethodsA randomized, open-label, parallel-cohort, confinement study of healthy adult smokers, naive to NSPS use, was conducted. Participants (N = 90) were randomized to six cohorts (n = 15 each): exclusive ad libitum use of NSPS (four flavors: Virginia Tobacco, Mint, Mango, Creme), continuation of usual-brand cigarette smoking, or cigarette abstinence. Total nicotine equivalents and BoE (NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, 1-OHP, and COHb) were measured.ResultsEight non-nicotine BoEs, measured in urine, were reduced by an aggregate of 85.0% in the pooled NSPS cohort; increased by 14.4% in the cigarette cohort (p < .001 for pooled NSPS vs. cigarette); and reduced by 85.3% in the abstinence cohort (p > .05; 99.6% relative reduction between pooled NSPS vs. abstinence). Similar changes in individual BoEs were also observed (p < .001 for each BoE between pooled NSPS vs. cigarettes; and abstinence vs. pooled NSPS; p > .05 for each BoE between pooled NSPS vs. abstinence). Blood COHb decreased by 71.8% in the pooled NSPS cohort and 69.1% in the abstinence cohort (p > .05) and increased by 13.3% in the cigarette cohort (p < .001). Mean total urine nicotine equivalents increased in the pooled NSPS and cigarette cohorts by 9% and 26%, respectively, and did not significantly differ (p > .05).ConclusionComplete switching from cigarettes to NSPS produced significant reductions in key non-nicotine BoEs associated with cigarette smoking.ImplicationsThe results of this study concorded with evidence that complete switching from combustible cigarettes to tobacco and nontobacco-flavored vapor products may reduce exposure to key carcinogens and other toxicants known to be associated with tobacco-related diseases. Future research is needed to assess the long-term health effects of NSPS use. These results should not be interpreted to mean that the use of NSPS is without any risk, particularly for nonusers of tobacco products.
Highlights
This study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers
A temperature control system integrated into the breath-actuated inhalation pathway is designed to maintain a consistent operating temperature, independent of puff intensity, to minimize the creation of combustionrelated by-products under a range of conditions, including “dry wick.” 16 far, data assessing exposure to key BoEs among adult smokers who switch to NSPS has been limited to demonstrations of reduced exposure to carbon monoxide associated with acute use of NSPS versus combusted cigarettes, and indirectly through toxicological studies comparing harmful and potentially harmful constituent (HPHC) emissions of NSPS versus combusted cigarettes.[17–19]
The most frequent was presyncope related to blood draws (8%) and all remaining events were experienced by three or fewer (≤3%) subjects overall (Supplementary Table S7). This randomized controlled study found that after 5 days of substituting NSPS use for combustible cigarettes, the levels of nine clinically relevant non-nicotine BoEs significantly decreased and these reductions were comparable to those observed with smoking abstinence
Summary
This study examined changes in biomarkers of exposure (BoE) after 5 days of nicotine-salt pod system (NSPS) use, compared with continuation of usual-cigarette smoking and cigarette abstinence, among adult combustible cigarette smokers. Implications: The results of this study concorded with evidence that complete switching from combustible cigarettes to tobacco and nontobacco-flavored vapor products may reduce exposure to key carcinogens and other toxicants known to be associated with tobacco-related diseases. A 2018 National Academies of Science, Engineering and Medicine consensus report and other reports have concluded that “there is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes.” 5,6 Evidence suggests that adult smokers who completely switch from combustible cigarettes to electronic nicotine delivery system (ENDS) products may reduce short-term adverse health outcomes.[7,8]. A temperature control system integrated into the breath-actuated inhalation pathway is designed to maintain a consistent operating temperature, independent of puff intensity, to minimize the creation of combustionrelated by-products under a range of conditions, including “dry wick.” 16 far, data assessing exposure to key BoEs among adult smokers who switch to NSPS has been limited to demonstrations of reduced exposure to carbon monoxide associated with acute use of NSPS versus combusted cigarettes, and indirectly through toxicological studies comparing harmful and potentially harmful constituent (HPHC) emissions of NSPS versus combusted cigarettes.[17–19]
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