Perceptions, intentions, and actual use of a consumer nicotine gum.

BACKGROUND: Little is known about perceptions, use intentions, and behaviors of adults regarding nicotine gum that is marketed and regulated as a consumer product rather than as a medicinal nicotine replacement therapy (NRT). METHODS: Survey data were collected from a Qualtrics online panel (N = 1000) of adults who had never used a consumer nicotine gum, recruited based on smoking behavior, and from current and former purchasers of one commercially available nicotine gum product (LUCY Chew and Park), recruited via emails to a customer database (N = 500). In addition to descriptive cross-sectional analyses, logistic regression was used to estimate the probability of intent to try and of product appeal among these different groups. RESULTS: Among online panel respondents, individuals who smoked with and without plans to quit showed high intention to try the product (odds ratios 15.6 [95% CI 9.3, 27.6] and 9.8 [95% CI 5.8, 17.3] respectively, compared to people who formerly smoked) and persons who had never smoked showed low intentions to try. These results stood regardless of flavor. Among current and former purchasers of the study product, 43.4% of persons who had smoked cigarettes regularly indicated they were motivated to try the product "to help me quit smoking." Only 0.6% of young adult consumers of the nicotine gum (aged 21-30) had not tried tobacco products previously. CONCLUSIONS: Consumer nicotine gum does not appear to attract those who have never used a tobacco product and the results for young adults suggest minimal appeal to youth. The study product was used primarily by individuals who currently smoke and/or use e-cigarettes but who wished to quit or reduce consumption. These results suggest that a consumer nicotine gum may reduce harm by substituting for higher-risk products such as combustible cigarettes.

Human Abuse Liability Assessment of Tobacco and Nicotine Products: Approaches for Meeting Current Regulatory Recommendations.

Many regulatory bodies now recommend that tobacco product manufacturers provide information regarding new tobacco products' abuse liability to inform regulatory authorization of currently marketed tobacco products or new product applications (including premarket tobacco product applications in the United States). In addition, the US Food and Drug Administration (FDA) recommends including this information as part of modified risk tobacco product applications. Regulators, including FDA, and many public health officials and researchers consider abuse liability assessment a model which predicts the likelihood that the use of the tobacco product would result in addiction and be used repeatedly or even sporadically resulting in undesirable effects. Abuse liability of a new, potentially reduced harm product can also inform its ability to substitute completely for more harmful tobacco products. While many methods exist, no standard tobacco product abuse liability assessment has been established. The purpose of this review is to provide background information and practical recommendations for human abuse liability testing methods to meet tobacco regulatory needs. A combination of nicotine test product pharmacokinetic, subjective effect and/or behavioral response, and physiological response data relative to comparator products with known abuse liability satisfies some regulatory requirements. Implications: This review provides a practical inspection of the current, international regulatory recommendations for abuse liability assessment of tobacco and regulatory review of such information within the United States and also recommends study designs and methods for abuse liability testing of tobacco products based on scientific and regulatory knowledge. Given that tobacco product abuse liability testing is of increasing interest to regulatory bodies globally, especially with the emergence of novel tobacco products, this timely work provides background and functional recommendations for tobacco product abuse liability testing.

Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to Tobacco Heating Products: A Randomized, Controlled Study in Healthy Japanese Subjects.

BACKGROUND: Smoking is a leading cause of numerous human disorders including pulmonary disease, cardiovascular disease, and cancer. Disease development is primarily caused by exposure to cigarette smoke constituents, many of which are known toxicants. Switching smokers to modified risk tobacco products (MRTPs) has been suggested as a potential means to reduce the risks of tobacco use, by reducing such exposure. METHODS: This randomized, controlled study investigated whether biomarkers of toxicant exposure (BoE) were reduced when smokers switched from smoking combustible cigarettes to using a novel (glo™/THP1.0) or in-market comparator (iQOS/THS) tobacco heating product (THP). One hundred eighty Japanese smokers smoked combustible cigarettes during a 2-day baseline period, followed by randomization to either continue smoking cigarettes, switch to using mentholated or non-mentholated variants of glo™, switch to using a non-mentholated variant of iQOS, or quit nicotine and tobacco product use completely for 5 days. Baseline and post-randomization 24-h urine samples were collected for BoE analysis. Carbon monoxide was measured daily in exhaled breath (eCO). RESULTS: On day 5 after switching, urinary BoE (excluding for nicotine) and eCO levels were significantly (p < .05) reduced by medians between 20.9% and 92.1% compared with baseline in all groups either using glo™ or iQOS or quitting tobacco use. Between-group comparisons revealed that the reductions in the glo™ groups were similar (p > .05) to quitting in many cases. CONCLUSIONS: glo™ or iQOS use for 5 days reduced exposure to smoke toxicants in a manner comparable to quitting tobacco use. THPs are reduced exposure tobacco products with the potential to be MRTPs. IMPLICATIONS: This clinical study demonstrates that when smokers switched from smoking combustible cigarettes to using tobacco heating products their exposure to smoke toxicants was significantly decreased. In many cases, this was to the same extent as that seen when they quit smoking completely. This may indicate that these products have the potential to be reduced exposure and/or reduced risk tobacco products when used by smokers whose cigarette consumption is displaced completely. CLINICAL TRIAL REGISTRATIONS: ISRCTN14301360 and UMIN000024988.

A randomised, controlled, two-Centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional cigarette to a tobacco heating product.

BACKGROUND: Smoking is a leading cause of numerous human disorders including lung cancer, chronic obstructive pulmonary disease, and atherosclerotic cardiovascular disease. The development of modified risk tobacco products (MRTPs) has been suggested as a possible way to reduce the risks of tobacco smoking by reducing exposure to cigarette smoke toxicants. This study is designed to investigate whether biomarkers of such exposure are reduced when smokers switch from smoking commercial cigarettes to using either a novel or a commercially-available tobacco heating product (THP). DESIGN AND METHODS: This study will assess biomarkers of exposure in current smokers who either remain smoking, switch to THP use, or quit all tobacco use completely, for 5 days. The study is an in-clinic (confinement) two-centre, randomised controlled clinical study with a forced-switching design. Subjects of either gender will be aged 23-55 years (minimum legal smoking age plus 3 years), of Japanese origin and with a verified smoking status (assessed by exhaled breath carbon monoxide and urinary cotinine levels). Subjects will have a usual brand cigarette within the International Organisation for Standardisation (ISO) tar band of 6-8 mg and will be judged to be healthy by medical history, physical examination, vital signs, electrocardiography (ECG), clinical biochemistry and lung function tests. The primary objective of this study is to assess changes within groups in selected biomarkers of exposure (BoE) and of biological effect (BoBE) after a forced switch from a commercial control cigarette to either a menthol or a non-menthol THP. Secondary objectives are to assess between-group differences, to determine nicotine pharmacokinetics for cigarettes and THPs, to assess subject's satisfaction with the study products, and to monitor additional endpoints related to safety and product use. DISCUSSION: Data from this study will advance our scientific understanding of the changes in exposure to cigarette smoke toxicants in smokers who switch to using a THP. TRIAL REGISTRATIONS: UMIN000024988 (25th November 2016); ISRCTN14301360 (14th December 2016).

Systematic review of biomarker findings from clinical studies of electronic cigarettes and heated tobacco products.

BACKGROUND: Worldwide adoption of electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs) has increased exponentially over the past decade. These products have been proposed as non-combustible alternatives to traditional tobacco products such as cigarettes and may thus reduce the negative health consequences associated with tobacco smoke. However, the overall health impact and safety of using these products remains unclear. This review seeks to provide an updated summary of available evidence on changes to levels of tobacco-related biomarkers to aid the overall assessment of the consequences of using e-cigarettes and HTPs. METHODS: A systematic review was conducted through major databases (Medline/PubMed, Scopus, EMBASE) searching for articles directly comparing biomarker levels in humans using e-cigarettes or HTPs and those using combustible cigarettes. We included peer reviewed articles with comparative or longitudinal design and extracted key information for our purpose (type of population, demographics, biomarkers measurements, and health effects). An initial qualitative analysis was performed followed by a summary of findings. RESULTS: A total of 44 studies were included from initial citations. The vast majority of the literature reported reductions in levels of biomarkers of tobacco smoke exposure (BOE), especially nicotine, MHBMA, 3-HPMA, S-PMA, 1-OHP and NNAL, when using e-cigarettes and HTPs compared to combustible cigarettes. There was a slight tendency toward a larger reduction in these biomarkers levels with the use of e-cigarettes, although direct comparisons between e-cigarettes and HTPs were lacking. There was also a trend toward positive changes in levels of biomarkers of biological effect (BOBE) with the use of e-cigarettes and HTPs. CONCLUSIONS: A comparison of levels of biomarkers of tobacco-related exposure collected in clinical studies revealed that the use of e-cigarettes and HTPs could lead to a significant reduction in exposure to harmful substances compared to combusted cigarettes. In tandem, the health status of e-cigarettes and HTP users, indexed by levels of biomarkers of biological effect showed potential for improvement compared to smoking. However, larger and longer-term population-based studies are needed to further clarify these findings.

Succession Patterns and Physical Niche Partitioning in Microbial Communities from Subsurface Coal Seams.

The subsurface represents a largely unexplored frontier in microbiology. Here, coal seams present something of an oasis for microbial life, providing moisture, warmth, and abundant fossilized organic material. Microbes in coal seams are thought to syntrophically mobilize fossilized carbon from the geosphere to the biosphere. Despite the environmental and economic importance of this process, little is known about the microbial ecology of coal seams. In the current study, ecological succession and spatial niche partitioning are explored in three coal seam microbial communities. Scanning electron microscopic visualization and 16S rRNA sequencing track changes in microbial communities over time, revealing distinct attached and planktonic communities displaying patterns of ecological succession. Attachment to the coal surface is biofilm mediated on Surat coal, whereas microbes on Sydney and Gunnedah coal show different attachment processes. This study demonstrates that coal seam microbial communities undergo spatial niche partitioning during periods of succession as microbes colonize coal environments.