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

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.

SUBMITTER: Kanobe MN

PROVIDER: S-EPMC9712618 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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

Kanobe Milly N MN Jones Bobbette A BA Nelson Paul P Brown Buddy G BG Chen Peter P Makena Patrudu P Schmidt Eckhardt E Darnell John J Caraway John W JW Prasad G L GL Nordskog Brian B Round Elaine K EK

Scientific reports 20221130 1

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 ...[more]

PMID: 36450821

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Project description:IntroductionSwitching to noncombustible tobacco products presents an opportunity for cigarette smokers to potentially reduce the health risks associated with smoking. Electronic Nicotine Delivery Systems (ENDS) are one such product because the vapor produced from ENDS contains far fewer toxicants than cigarette smoke. To investigate the biochemical effects of switching from smoking to an ENDS, we assessed global metabolomic profiles of smokers in a 7-day confinement clinical study.MethodsIn the first 2 days of this clinical study, the subjects used their usual brand of cigarettes and then switched to exclusive ENDS ad libitum use for 5 days. Urine and plasma samples were collected at baseline and 5 days after switching. The samples were analyzed using a mass spectrometry-based metabolomic platform.ResultsRandom forest analyses of urine and plasma metabolomic data revealed excellent predictive accuracy (>97%) of a 30-metabolite signature that can differentiate smokers from 5-day ENDS switchers. In these signatures, most biomarkers are nicotine-derived metabolites or xenobiotics. They were significantly reduced in urine and plasma, suggesting a decreased xenobiotic load on subjects. Our results also show significantly decreased levels of plasma glutathione metabolites after switching, which suggests reduced levels of oxidative stress. In addition, increased urinary and plasma levels of vitamins and antioxidants were identified, suggesting enhanced bioavailability due to discontinuation of cigarette smoking and switching to Vuse ENDS use.ConclusionsOur results suggest reduced toxicant exposure, reduced oxidative stress, and potential beneficial changes in vitamin metabolism within 5 days in smokers switching to Vuse ENDS.ImplicationsSwitching from smoking to exclusive ENDS use in clinical confinement settings results in significant reduction of nicotine metabolites and other cigarette-related xenobiotics in urine and plasma of subjects. Significantly decreased oxidative stress-related metabolites and increased urinary and plasma levels of vitamin metabolites and antioxidants in 5-day short-term ENDS switchers suggest less toxic physiological environment for consumers of ENDS products and potential health benefits if such changes persist.

Project description:AimsTo estimate the association of longitudinal patterns of e-cigarette use with cigarette smoking abstinence, after accounting for time-dependent confounding and selection bias.DesignSecondary analysis of longitudinal national cohort data. Using marginal structural models and four waves of the population assessment of tobacco and health (wave 1, 2013-14; wave 2, 2014-15; wave 3, 2015-16; wave 4, 2016-18), we estimated the association of vaping frequency across waves 2 and 3 with 12-month sustained cigarette smoking abstinence at wave 4, adjusting for time-dependent confounders at waves 1 and 2 and selection bias due to drop-out with inverse probability of treatment and censoring weights.SettingUnited States.Participants/casesA total of 5699 adults (18+ years) who smoked cigarettes and did not vape at wave 1.MeasurementsThe exposure was vaping frequency at waves 2 and 3 (non-use, non-daily use, daily use), representing nine possible combinations of vaping frequency across two waves. Non-use at both waves was the exposure reference group. The primary outcome was sustained 12-month cigarette smoking abstinence at wave 4.FindingsAmong 5699 adults who smoked cigarettes at wave 1, a total of 560 (9.8%) reported smoking abstinence at wave 4. Compared with nonuse at both waves, daily vaping at both waves [risk ratio (RR) = 3.82, 95% confidence interval (CI) = 2.59-5.64] and non-use at wave 2 followed by daily vaping at wave 3 (RR = 2.50, 95% CI = 1.66-3.77) were positively associated with smoking abstinence; non-daily vaping at both waves was inversely associated with smoking abstinence (RR = 0.28, 95% CI = 0.11-0.75). Results persisted after accounting for misclassification of e-cigarette use and cigarette smoking abstinence and after restricting to participants with plans to quit smoking.ConclusionsIn a US cohort of adult smokers, longitudinal patterns of vaping frequency appear to predict smoking abstinence, even after accounting for several sources of systematic error. Consistent daily vaping is associated with increased chances of cigarette smoking abstinence, while consistent non-daily vaping is associated with decreased chances of smoking abstinence.

Project description:IntroductionThe major aim of this study was to test whether abstinence from e-cigarettes causes withdrawal symptoms in former smokers.MethodsWe conducted an unblinded, within-participants, pre-post clinical trial in which 109 former smokers who were current daily electronic cigarette (e-cigarette) users used their own e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence engendered via an escalating contingency payment system. Participants monitored symptoms of nicotine withdrawal daily via an Interactive Voice Response system. They also attended three laboratory visits per week for carbon monoxide and cotinine testing to verify abstinence.ResultsHalf of participants completely abstained for a week. All the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) tobacco withdrawal symptoms, craving for e-cigarettes, craving for tobacco cigarettes, and the four possible new withdrawal symptoms (anhedonia, impulsivity, mood swings, and positive affect) increased during abstinence. Weight increased and heart rate decreased with abstinence. Symptoms showed the prototypical inverted U time pattern of a withdrawal state. The magnitude of withdrawal appeared to be somewhat less than that in a prior study of abstinent daily tobacco cigarette smokers. More severe withdrawal on the first 2 days of abstinence did not predict abstinence on the last day of the study.ConclusionsFormer smokers who are daily e-cigarette users transfer physical dependence on tobacco cigarettes to dependence on e-cigarettes. The severity of withdrawal from e-cigarettes appears to be only somewhat less than that from daily tobacco cigarette use. Replication tests that include placebo controls, testing for pharmacological specificity, and including never-smokers, non-daily e-cigarette users and dual users are indicated.ImplicationsOur results indicate e-cigarettes can maintain physical dependence. This adverse effect should be included in any risk vs. benefit calculation. Also, potential and current e-cigarette users should be informed that abrupt cessation of e-cigarettes can cause withdrawal symptoms.Trial registrationNCT02825459.

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

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

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