US Adult Interest in Less Harmful and Less Addictive Hypothetical Modified Risk Tobacco Products.

Introduction: Tobacco companies have a history of making health claims about their new products. Such claims are now regulated by the US Food and Drug Administration. We examined consumer interest in hypothetical modified risk tobacco products (MRTPs) among current, former, and never established smokers and examined whether interest was associated with beliefs about tobacco and cancer. Methods: Data were analyzed from the US nationally representative 2015 Health Information National Trends Survey (HINTS-FDA 2015; N = 3738). Interest in hypothetical MRTPs was assessed by asking participants their likelihood of using tobacco products claiming to be less addictive and less harmful than other products. Results: About half of current smokers and a tenth of both former and never smokers reported they were "somewhat" or "very" likely to try hypothetical MRTPs claiming to be less harmful or less addictive. Female smokers, former smokers with lower smoking harm perceptions, and never smokers who are young adults or without college education expressed more interest in these products. Interest in using these products was positively associated with believing that smoking status is a changeable individual characteristic and that it is possible for tobacco products to be made without some harmful chemicals. Conclusion: We identified several subgroups of current, former, and never smokers who may be particularly affected by the marketing of MRTPs and therefore important to study to inform models of the potential population health impact of authorizing the marketing of MRTPs. Implications: Findings about interest in hypothetical MRTPs can inform models of how the marketing of MRTPs could affect population health. Understanding which subgroups are particularly interested in MRTPs can help determine who might be important to study to inform these models. We identified several groups who may warrant specific attention: smokers who are female, former smokers who hold low harm perceptions of smoking, never smokers who are young adults or have a high school education or less, people who believe that smoking is a changeable individual characteristic, and people who believe that it is possible to make low chemical tobacco products.

U.S. adults' addiction and harm beliefs about nicotine and low nicotine cigarettes.

This research described U.S. adults' beliefs about nicotine and low nicotine cigarettes (LNCs) using the nationally-representative Health Information National Trends Survey (HINTS-FDA 2015; N=3738). About three quarters of people either were unsure of the relationship between nicotine and cancer or incorrectly believed that nicotine causes cancer. People who were non-White, less educated, age 65+, and never established smokers were most likely to be unaware that nicotine is not a cause of cancer. More than a quarter of people held the potentially inaccurate beliefs that LNCs would be less harmful and addictive than typical cigarettes. Whites were more likely than Blacks to believe LNCs were less harmful than typical cigarettes, and never smokers were more likely to believe this than established quitters. Whites and people with at least a college degree were more likely to believe that LNCs would be less addictive than typical cigarettes. Overall, we found that many people, particularly the demographic subgroups identified here, held incorrect beliefs about nicotine and potentially inaccurate beliefs about LNCs. Findings should be considered in assessing the public health impact of marketing low nicotine products. Incorrectly believing that nicotine causes cancer could discourage smokers from switching to safer nicotine-containing alternatives, and could lead nonsmokers to experiment with low nicotine tobacco products, believing that cancer risk would be reduced. Findings underscore the need to educate the public on the health effects of nicotine and LNCs, and can help public health practitioners determine which subgroups should be prioritized in targeted educational efforts.

Flavour preferences in youth versus adults: a review.

OBJECTIVE: To understand the available evidence of how children and adults differ in their preferences for flavours that may be used in tobacco products. DATA SOURCES: A total of 474 articles published between 1931 and August 2015 were retrieved through searches conducted in PubMed, EMBASE, Web of Science and PsycINFO. STUDY SELECTION AND EXTRACTION: A 2-phase relevancy review process resulted in the identification of 59 articles and information was extracted by 2 independent reviewers. DATA SYNTHESIS: Findings were grouped by taste and smell preferences, which are important components of overall flavour. For taste, evidence is summarised in the following categories: sweet, salty, sour, bitter, umami and fat; within each of them, findings are organised by age categories. For smell, evidence is summarised as follows: fruit/herbal/spices, tobacco and coffee and other odours. Major findings from this search indicated that sweet preference in children and adolescents was higher than in adults. Examples of preferred food-related tastes and odours for young people included cherry, candy, strawberry, orange, apple and cinnamon. Currently, all these are used to flavour cigars, cartridges for electronic cigarettes, hookah (waterpipe) and smokeless tobacco products. CONCLUSIONS: Infants and children exhibited elevated sweet and salty preference relative to adults. Age-related changes in bitter, sour, umami and fat taste were not clear and more research would be useful. 'Sweet' food odours were highly preferred by children. Tobacco products in flavours preferred by young people may impact tobacco use and initiation, while flavours preferred by adults may impact product switching or dual use.

Clinical pharmacology research strategy for dissolvable tobacco products.

INTRODUCTION: Dissolvable tobacco products (DTPs) are relatively new to the market. Some researchers and manufacturers describe them as finely ground tobacco that has been compressed into sticks, strips, and orbs that dissolve or disintegrate in the mouth and do not require spitting. While the pharmacokinetic profiles of nicotine and other tobacco-associated compounds and pharmacological effects of these products are complex, their clinical pharmacology has not been systematically evaluated. We reviewed the scientific literature regarding the known pharmacokinetic (PK) characteristics and pharmacodynamic (PD) effects of DTPs with the purpose of identifying research gaps and informing future studies. OBJECTIVES: To evaluate current knowledge of the pharmacological properties of DTPs; to assess their similarities and differences with other tobacco products, especially smokeless tobacco products, and Food and Drug Administration-approved nicotine replacement therapies; to identify gaps in existing information; and to propose a strategy for future clinical pharmacology studies of DTPs. METHODS: We reviewed the peer-reviewed literature and generated research questions for future clinical pharmacology studies. RESULTS AND CONCLUSIONS: Data on the PK and PD of DTPs are sparse and inconsistent. The results of existing studies are limited and inconclusive, and their interpretation is complicated by methodological and/or study design issues. This review identifies a need for larger, comprehensive, and prospectively designed studies that include PK/PD measurements and data analyses. We propose a research agenda for future DTP studies related to the clinical pharmacology of nicotine, its metabolites, tobacco-specific nitrosamines, and other toxic compounds.

Electronic cigarettes: abuse liability, topography and subjective effects.

OBJECTIVE: To review the available evidence evaluating the abuse liability, topography, subjective effects, craving and withdrawal suppression associated with e-cigarette use in order to identify information gaps and provide recommendations for future research. METHODS: Literature searches were conducted between October 2012 and January 2014 using five electronic databases. Studies were included in this review if they were peer-reviewed scientific journal articles evaluating clinical laboratory studies, national surveys or content analyses. RESULTS: A total of 15 peer-reviewed articles regarding behavioural use and effects of e-cigarettes published between 2010 and 2014 were included in this review. Abuse liability studies are limited in their generalisability. Topography (consumption behaviour) studies found that, compared with traditional cigarettes, e-cigarette average puff duration was significantly longer, and e-cigarette use required stronger suction. Data on e-cigarette subjective effects (such as anxiety, restlessness, concentration, alertness and satisfaction) and withdrawal suppression are limited and inconsistent. In general, study data should be interpreted with caution, given limitations associated with comparisons of novel and usual products, as well as the possible effects associated with subjects' previous experience/inexperience with e-cigarettes. CONCLUSIONS: Currently, very limited information is available on abuse liability, topography and subjective effects of e-cigarettes. Opportunities to examine extended e-cigarette use in a variety of settings with experienced e-cigarette users would help to more fully assess topography as well as behavioural and subjective outcomes. In addition, assessment of 'real-world' use, including amount and timing of use and responses to use, would clarify behavioural profiles and potential adverse health effects.

Electronic cigarettes and nicotine clinical pharmacology.

OBJECTIVE: To review the available literature evaluating electronic cigarette (e-cigarette) nicotine clinical pharmacology in order to understand the potential impact of e-cigarettes on individual users, nicotine dependence and public health. METHODS: Literature searches were conducted between 1 October 2012 and 30 September 2013 using key terms in five electronic databases. Studies were included in the review if they were in English and publicly available; non-clinical studies, conference abstracts and studies exclusively measuring nicotine content in e-cigarette cartridges were excluded from the review. RESULTS: Nicotine yields from automated smoking machines suggest that e-cigarettes deliver less nicotine per puff than traditional cigarettes, and clinical studies indicate that e-cigarettes deliver only modest nicotine concentrations to the inexperienced e-cigarette user. However, current e-cigarette smokers are able to achieve systemic nicotine and/or cotinine concentrations similar to those produced from traditional cigarettes. Therefore, user experience is critically important for nicotine exposure, and may contribute to the products' ability to support and maintain nicotine dependence. CONCLUSIONS: Knowledge about e-cigarette nicotine pharmacology remains limited. Because a user's e-cigarette experience may significantly impact nicotine delivery, future nicotine pharmacokinetic and pharmacodynamic studies should be conducted in experienced users to accurately assess the products' impact on public health.

Abuse potential of non-nicotine tobacco smoke components: acetaldehyde, nornicotine, cotinine, and anabasine.

INTRODUCTION: This review identified published animal studies evaluating the possible abuse potential of acetaldehyde, nornicotine, cotinine, and anabasine based on five commonly used paradigms. These include their effects on midbrain dopamine (DA) levels, drug discrimination and substitution for known drugs of abuse, place conditioning, self-administration behavior, and somatic withdrawal symptoms. RESULTS: Acetaldehyde had mixed effects on midbrain DA levels and drug discrimination; however, it consistently produced a conditioned place preference and supported self-administration. The single available study on withdrawal found that cessation of acetaldehyde administration resulted in a somatic withdrawal syndrome. Nornicotine increased DA in the midbrain, especially in the nucleus accumbens. Although there are no data on place conditioning, it substituted for nicotine in drug discrimination testing, partially substituted for cocaine and amphetamine, and, though only a single study, supported self-administration. Anabasine increased midbrain DA levels and that it partially substituted for nicotine in drug discrimination testing. Cotinine increased midbrain DA levels and substituted for nicotine. CONCLUSIONS: The existing literature suggests that acetaldehyde and nornicotine likely possess abuse potential, with anabasine having possible abuse potential. Although some cotinine data were available, it was insufficient to draw conclusions about possible abuse potential. Further research is needed to determine the role of minor alkaloids on tobacco dependence.

Media exposure and tobacco product addiction beliefs: Findings from the 2015 Health Information National Trends Survey (HINTS-FDA 2015).

BACKGROUND: Addiction beliefs about tobacco use are associated with intentions to use and use of tobacco products. Exposure to information about tobacco products in media sources may affect addiction beliefs. PURPOSE: To examine the relationship between media exposure and tobacco product addiction beliefs. METHODS: A nationally representative sample of US adults (n=3738) from the 2015 National Cancer Institute's Health Information National Trends Survey was used to examine addiction beliefs about cigarettes, cigars, smokeless tobacco, electronic cigarettes, hookah/waterpipe tobacco, and roll-your-own cigarettes. We used logistic regression to examine the relationship between media exposure and addiction beliefs. We defined media exposure by hours exposed, as well as exposure to tobacco use health effects information through media sources including social media. We categorized media sources by whether respondents actively or passively engaged with the source. FINDINGS: A majority (60.6% to 87.3%) of respondents believed that cigarettes, cigars, roll-your-own cigarettes and smokeless tobacco are addictive. Less than half of respondents believed that electronic cigarettes or hookah/waterpipes are addictive (45.2% and 49.8%, respectively). Respondents exposed to messages about tobacco use health effects on active media channels (e.g., social media) had greater odds of believing that smokeless tobacco (adjusted odds ratio [AOR]=1.48), hookah/waterpipe (AOR=1.69), and roll-your-own cigarettes (AOR=1.61) are addictive. Respondents exposed to tobacco use health effects messages on passive media channels (e.g., television), had greater odds of believing that cigarettes (AOR=2.76) and electronic cigarettes (AOR=2.12) are addictive. CONCLUSIONS: US adult exposure to information about the health effects of tobacco use was associated with addiction beliefs about tobacco products.

Mouth Level Exposure and Similarity to Machine-smoked Constituent Yields.

OBJECTIVES: The goal of this review was to evaluate which standard machine-smoking regimen may be most appropriate to inform tobacco product regulation based on the fraction of cigarette smoke yields that best represents the range of human smoke exposures. METHODS: We searched PubMed and Web of Science to identify peer-reviewed studies that reported percentages of smokers who smoked more or less like a particular machine-smoking regimen based on human mouth level exposure (MLE) tobacco constituent yields. RESULTS: Three studies met our inclusion criteria and were reviewed. Studies found that Canadian Intense (CI) yields were equal to or greater than 86% to 97% of smokers' nicotine and tar MLE yields. CONCLUSIONS: MLE yields indicate that a small percentage of individuals (less than 14%) are exposed to nicotine and tar yields equal to or greater than those measured by the CI regimen. Whereas no machine-smoking regimen reflects human puffing behavior with complete accuracy, based on MLE data, CI constituent yields constitute the best representation of exposure that encompasses the majority of smokers, and may be the most informative for regulatory purposes.

Measurement of multiple nicotine dependence domains among cigarette, non-cigarette and poly-tobacco users: Insights from item response theory.

BACKGROUND: Nicotine dependence (ND) is a key construct that organizes physiological and behavioral symptoms associated with persistent nicotine intake. Measurement of ND has focused primarily on cigarette smokers. Thus, validation of brief instruments that apply to a broad spectrum of tobacco product users is needed. METHODS: We examined multiple domains of ND in a longitudinal national study of the United States population, the United States National Epidemiological Survey of Alcohol and Related Conditions (NESARC). We used methods based in item response theory to identify and validate increasingly brief measures of ND that included symptoms to assess ND similarly among cigarette, cigar, smokeless, and poly tobacco users. RESULTS: Confirmatory factor analytic models supported a single, primary dimension underlying symptoms of ND across tobacco use groups. Differential Item Functioning (DIF) analysis generated little support for systematic differences in response to symptoms of ND across tobacco use groups. We established significant concurrent and predictive validity of brief 3- and 5-symptom indices for measuring ND. CONCLUSIONS: Measuring ND across tobacco use groups with a common set of symptoms facilitates evaluation of tobacco use in an evolving marketplace of tobacco and nicotine products.

Youth tobacco cessation: quitting intentions and past-year quit attempts.

BACKGROUND: Despite declining use of conventional tobacco products, youth use of non-cigarette tobacco has become prevalent; however, quitting behaviors remain largely unexplored. PURPOSE: To examine nationally representative data on quit intentions and past-year attempts to quit all tobacco use among current youth tobacco users. METHODS: In 2013, data were analyzed from the 2012 National Youth Tobacco Survey (NYTS). Weighted prevalence estimates of quit intentions and past-year quit attempts for current youth tobacco users are presented. RESULTS: Prevalence of quit intentions and past-year attempts to quit all tobacco use were 52.8% and 51.5%, respectively, among current youth tobacco users. Among non-mutually exclusive groups, current cigarette smokers had the highest prevalence of quit intentions (56.8%) and past-year quit attempts (52.5%), whereas current hookah users had the lowest prevalence of quit intentions (41.5%) and past-year quit attempts (43.7%). Quit intentions among black, non-Hispanics (65.0%) and Hispanics (60.4%) were significantly higher versus white, non-Hispanics (47.5%). Youth reporting parental advice against tobacco had significantly higher prevalence of quit intentions (56.7%) and past-year quit attempts (55.0%) than those not reporting parental advice. Youth who agreed all tobacco products are dangerous (58.5%) had significantly higher prevalence of quit intentions than those who disagreed (37.0%). CONCLUSIONS: Continued efforts are needed to better understand youth motivation for quitting all tobacco products. Public health messaging about the dangers of all tobacco and cessation efforts should be aimed at the full range of tobacco products, not just cigarettes, and tailored to meet the needs of youth polytobacco users.

Symptoms of tobacco dependence among middle and high school tobacco users: results from the 2012 National Youth Tobacco Survey.

BACKGROUND: A growing body of evidence suggests that tobacco dependence symptoms can occur soon after smoking onset and with low levels of use. However, limited data are available nationally and among non-cigarette tobacco users. PURPOSE: To examine the prevalence and determinants of tobacco dependence symptoms among adolescent tobacco users in the 2012 National Youth Tobacco Survey, a nationally representative, school-based survey of U.S. middle and high school students. METHODS: Multivariate logistic regression was used to identify independent predictors of dependence symptoms among current users (i.e., past 30-day use) of cigarettes, cigars, or smokeless tobacco. Analyses were conducted in 2013 using SAS-callable SUDAAN, version 11 to account for the complex survey design. RESULTS: Prevalence of tobacco dependence symptoms ranged from 20.8% (95% CI=18.6, 23.1) of current tobacco users reporting wanting to use tobacco within 30 minutes of waking to 41.9% (95% CI=39.3, 44.5) reporting recent strong cravings. Reporting of dependence symptoms was most consistently associated with polytobacco use, higher frequency of use, earlier initiation age, and female gender. A 2-4-fold increase in the odds of symptom reporting was found in adolescents using tobacco products on as few as 3-5 days compared to those who only used it for 1-2 of the past 30 days. CONCLUSIONS: A substantial proportion of U.S. adolescent tobacco users, including those with low levels of use, report symptoms of tobacco dependence. These findings demonstrate the need for full implementation of evidence-based strategies to prevent both experimentation and progression to regular tobacco use among youth.

The health effects of menthol cigarettes as compared to non-menthol cigarettes.

Since the 1920s, menthol has been added to cigarettes and used as a characterizing flavor. The health effects of cigarette smoking are well documented, however the health effects of menthol cigarettes as compared to non-menthol cigarettes is less well studied. This review discusses menthol's effects on 1) biomarkers of tobacco smoke exposure, 2) toxicity and cellular effects, 3) lung function and respiration, 4) pulmonary and/or vascular function, 5) allergic reactions and inflammation, and 6) tobacco-related diseases. It is concluded that menthol is a biologically active compound that has effects by itself and in conjunction with nicotine, however much of the data on the other areas of interest are inconclusive and firm conclusions cannot be drawn.

Menthol cigarette smoking and nicotine dependence.

Since tobacco use is driven by dependence on nicotine, the primary addictive substance in tobacco, much research has focused on nicotine dependence. Less well understood, however, is the role that menthol plays in nicotine dependence. This review seeks to examine what role, if any, menthol plays in nicotine addiction in adults and youth. Based on research examining several indicators of heaviness of nicotine addiction, including time to first cigarette upon waking, night waking to smoke, as well as some other indications of dependence, it is suggested that menthol cigarette smokers are more heavily dependent on nicotine. Although other indicators of nicotine dependence, including number of cigarettes per day and the Fagerstrom Test of Nicotine Dependence, failed to consistently differentiate menthol and non-menthol smokers, these indicators are thought to be less robust than time to first cigarette. Therefore, though limited, the existing literature suggests that menthol smokers may be more dependence on nicotine.

Menthol cigarettes and smoking cessation behavior.

Although much is known about smoking cessation behavior, the vast majority of research has not assessed menthol as an independent factor. The objective of this review is to assess the effects, if any, that use of menthol cigarettes has on smoking cessation success in adults and youth. A total of 20 articles are included in this review. Although some studies have found that menthol smokers have less success in quitting smoking, others fail to find significant differences between menthol and non-menthol smokers. Some clinical trials evaluating the efficacy of various cessation treatments have suggested that menthol smokers have poorer outcomes, however two secondary data analysis studies (which used the same original dataset) failed to find any difference in success rate associated with particular treatments. Although there is some suggestion that smoking menthol cigarettes is associated with worse cessation outcomes, differences are not always found. However, if there was a difference, it was always in the direction of worse outcomes for menthol smokers. Given that Black/African American smokers prefer menthol cigarettes more than White smokers, possible interactions with race/ethnicity are discussed.

Sensory properties of menthol and smoking topography.

Although there is a great deal known about menthol as a flavoring agent in foods and confections, less is known about the particular sensory properties of menthol cigarette smoke. Similarly, although smoking topography (the unique way an individual smokes a cigarette) has been well studied using non-menthol cigarettes, there is relatively less known about how menthol affects smoking behavior. The objective of this review is to assess the sensory properties of menthol tobacco smoke, and smoking topography associated with menthol cigarettes. The cooling, analgesic, taste, and respiratory effects of menthol are well established, and studies have indicated that menthol's sensory attributes can have an influence on the positive, or rewarding, properties associated smoking, including ratings of satisfaction, taste, perceived smoothness, and perceived irritation. Despite these sensory properties, the data regarding menthol's effect on smoking topography are inconsistent. Many of the topography studies have limitations due to various methodological issues.