Biomarker of exposure level data set in smokers switching from conventional cigarettes to Tobacco Heating System 2.2, continuing smoking or abstaining from smoking for 5 days.
Ontology highlight
ABSTRACT:
SUBMITTER: Haziza C
PROVIDER: S-EPMC5156600 | biostudies-literature | 2017 Feb
REPOSITORIES: biostudies-literature
Publications
Biomarker of exposure level data set in smokers switching from conventional cigarettes to Tobacco Heating System 2.2, continuing smoking or abstaining from smoking for 5 days.
Haziza Christelle C de La Bourdonnaye Guillaume G Skiada Dimitra D Ancerewicz Jacek J Baker Gizelle G Picavet Patrick P Lüdicke Frank F
Data in brief 20161118
Levels of biomarkers of exposure to selected harmful and potentially harmful smoke constituents found in cigarette smoke, in addition to nicotine were measured in 160 smokers randomized for 5 days to continuing smoking conventional cigarettes (41 participants), switching to Tobacco Heating System 2.2 (THS 2.2) (80 participants), or abstaining from smoking (39 participants). The data reported here are descriptive statistics of the levels of each biomarker of exposure expressed as concentrations a ...[more]
Similar Datasets
Project description:IntroductionBans of menthol characterizing flavor in cigarettes have been implemented in some localities and have been proposed more broadly. One proposed benefit of such a ban is to increase cessation rates among current menthol smokers. There is currently relatively limited data regarding how smoking behavior changes if menthol smokers switch to non-menthol cigarettes.Aims and methodsAfrican American menthol smokers interested in quitting smoking were randomized to either continue smoking menthol (n = 60) or switch to non-menthol cigarettes (n = 62) for 1 month prior to a cessation attempt. Cessation results were reported previously; this analysis reports the results from the pre-cessation visits at which amount smoked, exhaled carbon monoxide (CO) concentration, urinary cotinine concentrations, and subjective measures were assessed.ResultsOver the 4-week study period, those switching to non-menthol (vs. continuing to smoke menthol) cigarettes smoked fewer cigarettes per day (mean ratio: 0.86; 95% confidence interval [CI]: 0.76, 0.98; p = .02), reported lower withdrawal symptom severity (mean difference -1.29; 95% CI: -2.6 to -0.01; p = .05) and higher perceived effectiveness of their skills for quitting smoking (mean difference 0.56; 95% CI: 0.02-1.10; p = .05). No significant differences were found between groups in exhaled CO, urinary cotinine concentrations, or most other subjective effects including support for a ban on menthol characterizing flavor in cigarettes.ConclusionsThese results suggest that were menthol cigarettes no longer available, those that switch to non-menthol cigarettes would not change their smoking behavior in a way that is likely to be more hazardous, with some indicators suggesting that there may be some benefit.Clinicaltrials.gov # NCT02342327.ImplicationsA ban on menthol characterizing flavor in cigarettes has been proposed as a potential means by which to increase smoking cessation rates among current menthol cigarette smokers. This study evaluated how African American menthol cigarette smokers adjusted their smoking behavior after switching to non-menthol cigarettes. Although the overall differences between groups were modest, they were in a direction consistent with decreased smoking suggesting that current smokers would not adjust their behavior in a way that is likely to be more hazardous, with some indicators suggesting that there may be some benefits.
| S-EPMC8496474 | biostudies-literature
Project description:BACKGROUND:Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. OBJECTIVE:This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of pathomechanistic pathways (ie, inflammation, oxidative stress, lipid metabolism, respiratory function, and genotoxicity), linked to smoking-related diseases, in smokers switching from combustible cigarettes to THS 2.2. METHODS:This study was a randomized, controlled, two-arm parallel group, multicenter ambulatory US study conducted in healthy adult smokers switching from combustible cigarettes to THS 2.2 compared with smokers continuing to smoke combustible cigarettes for six months. Subjects had a smoking history of at least ten years and did not intend to quit within the next six months. RESULTS:Enrollment started in March 2015 and the trial was completed in September 2016. In total, 984 subjects were randomized (combustible cigarettes, n=483; THS 2.2, n=477), and 803 completed the study. The results are expected to be available in a subsequent publication in 2019. CONCLUSIONS:In this paper, we describe the rationale and design for this clinical study that focused on the evaluation of THS 2.2's potential to reduce the risk of smoking-related diseases compared with that of combustible cigarettes. This study will provide insights regarding favorable changes in biological and functional endpoints informed by effects known to be seen upon smoking cessation. TRIAL REGISTRATION:ClinicalTrials.gov NCT02396381; http://clinicaltrials.gov/ct2/show/NCT02396381 (Archived by WebCite at http://www.webcitation.org/71PCRdagP). REGISTERED REPORT IDENTIFIER:RR1-10.2196/11294.
| S-EPMC6128954 | biostudies-literature
Project description:IntroductionTobacco Heating System (THS) 2.2, a candidate modified-risk tobacco product, aims at offering an alternative to cigarettes for smokers while substantially reducing the exposure to harmful and potentially harmful constituents found in cigarette smoke.MethodsOne hundred and sixty healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Subjects were randomized in a 2:1:1 ratio to menthol Tobacco Heating System 2.2 (mTHS), menthol cigarette, or smoking abstinence for 5 days in confinement and 86 subsequent ambulatory days. Endpoints included biomarkers of exposure to harmful and potentially harmful constituents (reported in our co-publication, Part 1) and biomarkers of potential harm (BOPH).ResultsCompliance (protocol and allocated product exposure) was 51% and 18% in the mTHS and smoking abstinence arms, respectively, on day 90. Nonetheless, favorable changes in BOPHs of lipid metabolism (total cholesterol and high- and low-density cholesterol), endothelial dysfunction (soluble intercellular adhesion molecule-1), oxidative stress (8-epi-prostaglandin F2α), and cardiovascular risk factors (eg, high-sensitivity C-reactive protein) were observed in the mTHS group. Favorable effects in other BOPHs, including ones related to platelet activation (11-dehydrothromboxane B2) and metabolic syndrome (glucose), were more pronounced in normal weight subjects.ConclusionsThe results suggest that the reduced exposure demonstrated when switching to mTHS is associated with overall improvements in BOPHs, which are indicative of pathomechanistic pathways underlying the development of smoking-related diseases, with some stronger effects in normal weight subjects.ImplicationsSwitching to mTHS was associated with favorable changes for some BOPHs indicative of biological pathway alterations (eg, oxidative stress and endothelial dysfunction). The results suggest that switching to mTHS has the potential to reduce the adverse health effects of smoking and ultimately the risk of smoking-related diseases. Switching to mTHS for 90 days led to reductions in a number of biomarkers of exposure in smokers, relative to those who continued smoking cigarettes, which were close to those observed when stopping smoking (reported in our co-publication, Part 1). Initial findings suggest reduced levels of 8-epi-prostaglandin F2α and intercellular adhesion molecule 1, when switching to mTHS for 90 days. These changes are comparable to what is observed upon smoking cessation. In normal weight subjects, additional favorable changes were seen in 11-dehydrothromboxane B2, fibrinogen, homocysteine, hs-CRP, percentage of predicted forced expiratory volume in 1 second, systolic blood pressure, diastolic blood pressure, glucose, high-density lipoprotein, apolipoprotein A1, and triglycerides.Trial registrationNCT01989156.
| S-EPMC7164580 | biostudies-literature
Project description:INTRODUCTION:The Tobacco Heating System (THS) is a "heat-not-burn" tobacco product designed to generate significantly lower levels of harmful and potentially harmful constituents (HPHCs) and present lower risk of harm than cigarettes. This study assessed the exposure reduction to selected HPHCs in smokers switching to menthol Tobacco Heating System (mTHS) 2.2 compared with smokers continuing smoking menthol cigarettes (mCCs) and smoking abstinence (SA) for 5 days in a confined setting, followed by an 86-day ambulatory period. METHODS:A total of 160 healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Biomarkers of exposure to 16 HPHCs were measured in blood and 24-hour urine. Safety was monitored throughout the study. Information was also gathered on product evaluation, product use, subjective effects, and clinical risk markers (co-publication Part 2). RESULTS:Nicotine uptake was comparable in both exposure groups (mTHS:mCC ratio of 96% on day 90). On day 5, biomarker of exposure levels to other HPHCs were reduced by 51%-96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers of exposure over ambulatory period. After 90 days of use, the level of satisfaction with mTHS and suppression of urge to smoke were comparable to mCC. CONCLUSION:Switching from mCCs to mTHS significantly reduced the exposure to HPHCs to levels approaching those observed in subjects who abstained from smoking for the duration of the study. IMPLICATIONS:This study compared the impact of switching to mTHS on biomarkers of exposure, relative to continued smoking or SA. CLINICAL SIGNIFICANCE: TRIAL REGISTRATION:NCT01989156 (ClinicalTrials.gov).
| S-EPMC7164581 | biostudies-literature
Project description:To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial (CET).Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions.Community-based smokers in two communities in Wisconsin, USA.A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American (AA) menthol smokers. There were too few AA non-menthol smokers (n = 16) to be included in the analyses.Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo.Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit.In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio (OR) = 0.71, 95% confidence interval (CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66).In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females.
| S-EPMC4443703 | biostudies-literature
Project description:Nicotine exposure results in health risks not only for smokers but also for second- and third-hand smokers. Unraveling nicotine's degradation mechanism and the harmful chemicals that are produced under different conditions is vital to assess exposure risks. We performed a theoretical study to describe the early chemistry of nicotine degradation by investigating two important reactions that nicotine can undergo: hydrogen abstraction by hydroxyl radicals and unimolecular dissociation. The former contributes to the control of the degradation mechanism below 800 K due to a non-Arrhenius kinetics, which implies an enhancement of reactivity as temperature decreases. The latter becomes important at higher temperatures due to its larger activation energy. This change in the degradation mechanism is expected to affect the composition of vapors inhaled by smokers and room occupants. Conventional cigarettes, which operate at temperatures higher than 1000 K, are more prone to yield harmful pyridinyl radicals via nicotine dissociation, while nicotine in electronic cigarettes and vaporizers, with operating temperatures below 600 K, will be more likely degraded by hydroxyl radicals, resulting in a vapor with a different composition. Although low-temperature nicotine delivery devices have been claimed to be less harmful due to their nonburning operating conditions, the non-Arrhenius kinetics that we observed for the degradation mechanism below 873 K suggests that nicotine degradation may be more rapidly initiated as temperature is reduced, indicating that these devices may be more harmful than it is commonly assumed.
| S-EPMC8154610 | biostudies-literature
Project description:IntroductionMethadone maintenance treatment (MMT) patients have an exceedingly high prevalence of tobacco use, and interventions that have been specifically developed for this vulnerable subpopulation have struggled to attain even modest rates of cessation. A significant barrier has been an inability to initiate a quit attempt early in the treatment process and adherence to treatment.MethodsThis study examined the extent to which self-efficacy, medication adherence, and other demographic and smoking variables predicted an early quit day in a sample of MMT smokers (n = 315) enrolled in a smoking cessation pharmacotherapy trial. Using logistic regression, we estimated the association of having an early quit day-24hr without smoking during the first month of treatment.ResultsOnly 35.2% of participants reported a successful early quit day. The likelihood of an early quit day increased significantly (odds ratio [OR] = 1.39, 95% CI = 1.04-1.86, p < .05) with education level and if a quit attempt was made in the past year (OR = 2.27, 95% CI = 1.33-3.87, p < .01). Compared to the placebo arm, those randomized to either nicotine replacement therapy (OR = 3.25, 95% CI = 1.30-8.10, p < .01) or varenicline (OR = 3.16, 95% CI = 1.26-7.92) were significantly more likely to have an early quit day. The likelihood of an early quit day was also positively associated with adherence to the medication protocol (OR = 2.05, 95% CI = 1.52-2.76).ConclusionsDifficulty in achieving an early quit attempt may help explain the very low cessation rates found in studies of MMT smokers.
| S-EPMC4271088 | biostudies-literature
Project description:IntroductionSmokers tend to smoke when experiencing craving, but even within smoking occasions, craving may vary. We examine variations in craving when people were smoking in various real-world situations.MethodsUsing Ecological Momentary Assessment, 394 smokers recorded smoking, craving, and smoking context in real time on electronic diaries over 2 weeks of ad libitum smoking. Assessments occurred immediately prior to smoking. Mixed modeling was used to analyze associations between craving and situational variables.ResultsCraving varied across smoking situations, but the differences were small (<1 on a 0-10 scale). Specifically, craving was higher in smoking situations where smoking was restricted, likely because high craving leads smokers to violate restrictions. Controlling for restrictions, craving was higher when cigarettes were smoked while eating or drinking, were with other people (vs. alone), were in a group of people (vs. other people simply in view), during work (vs. leisure), and during activity (vs. inactivity). In addition, craving was higher for cigarettes smoked early in the day. No differences in craving were observed in relation to drinking alcohol or caffeine (vs. doing anything else), being at work (vs. home), being at a bar or restaurant (vs. all other locations), interacting with others (vs. not interacting), or other people smoking (vs. no others smoking).DiscussionEven though most craving reports prior to smoking were high, and situations were thus expected to have little influence on craving, results suggest that some cigarettes are craved more than others across different smoking situations, but differences are small.
| S-EPMC2825101 | biostudies-literature
Project description:Introduction:The menthol Tobacco Heating System 2.2 (mTHS) is a newly developed candidate modified-risk tobacco product intended to reduce exposure to the harmful and potentially harmful constituents (HPHCs) of conventional cigarette (CC) smoke. This study examined the impact of switching to mTHS on biomarkers of exposure to HPHCs relative to menthol CCs (mCCs) and smoking abstinence (SA). Methods:In this three-arm, parallel-group study, 160 Japanese adult smokers (23-65 years; smoking ?10 mCCs per day) were randomized to mTHS (n = 78), mCC (n = 42), or SA (n = 40) for 5 days in confinement and 85 days in ambulatory settings. Endpoints included biomarkers of exposure to HPHCs, human puffing topography, safety, and subjective effects of smoking measures. Results:After 5 days of product use, the concentrations of carboxyhemoglobin, 3-hydroxypropylmercapturic acid, monohydroxybutenyl mercapturic acid, and S-phenylmercapturic acid were 55%, 49%, 87%, and 89% lower (p < .001), respectively, in the mTHS group than in the mCC group. Other biomarkers of exposure (measured as secondary endpoints) were 50%-94% lower in the mTHS group than in the mCC group on day 5. These reductions in the mTHS group were maintained at day 90, similar to the SA group. Switching to mTHS was associated with changes in human puffing topography (shorter puff intervals and more frequent puffs). The urge-to-smoke and smoking satisfaction levels on day 90 were similar in the mTHS and the mCC groups. Conclusion:Switching from mCCs to mTHS significantly reduced exposure to HPHCs relative to continuing smoking mCCs with concentrations similar to those observed following SA in Japanese adult smokers. Implications:This randomized study compared the impact of switching to a modified-risk tobacco product candidate mTHS on biomarkers of exposure to HPHCs of cigarette smoke relative to continuing smoking cigarettes or abstaining from smoking in sequential confinement and ambulatory settings. The study showed that switching to mTHS was associated with significant biomarker reductions within 5 days in confinement, these reductions being maintained throughout the ambulatory setting up to day 90. The results provide evidence that switching to mTHS reduces real-life exposure to HPHCs in adult smokers.
| S-EPMC5896533 | biostudies-literature
Project description:IntroductionCo-use of tobacco and marijuana is common, and research suggests that marijuana use may be a barrier to smoking cessation. Research to date has not evaluated how marijuana use affects e-cigarette switching behaviors and related outcomes in a harm reduction trial.Aims and methodsThis secondary analysis includes African American (48%) and Latinx (52%) adult smokers randomized to the e-cigarette group (N = 114) of a harm reduction clinical trial from 2018 to 2019. Participants were provided JUUL e-cigarettes and encouraged to make an exclusive switch for 6 weeks. Our primary outcome was cigarettes smoked per week. Secondary health outcomes were e-cigarette substitution (calculated by measuring e-cigarette pod use), expired carbon monoxide (CO), and respiratory symptoms. Marijuana products were recorded at three timepoints and coded for combustion.ResultsMarijuana use during the study (n = 52, 46%) was not associated with week 6 cigarettes smoked or e-cigarette substitution, and combustible marijuana use was not associated with week 6 respiratory symptoms (ps > .05). After controlling for cigarettes smoked at week 6, combustible marijuana use was significantly associated with a 4.4 ppm increase in CO compared with no use of marijuana (p = .001).ConclusionsMarijuana use was not a barrier to switching to e-cigarettes in this 6-week trial. Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking. Marijuana co-use may increase risk of adverse health outcomes and may be a confounding factor when using CO as an endpoint to bioverify exclusive e-cigarette use.ImplicationsThis is the first known study to examine the effects of marijuana use on smokers switching to e-cigarettes. Marijuana use was not a barrier to cigarette reduction in a 6-week randomized clinical trial. Marijuana use uniquely contributed to higher carbon monoxide among cigarette smokers, indicating greater exposure to toxic combustion products, which could increase risk of adverse health outcomes. Furthermore, combustible marijuana use may be a confounding factor when CO is used as an endpoint to bioverify exclusive e-cigarette use.
| S-EPMC9199934 | biostudies-literature