Effects of advertising features on smokers' and non-smokers' perceptions of a reduced nicotine cigarette modified risk tobacco product.

INTRODUCTION: Research is needed to determine the impact of marketing on perceptions and use of reduced nicotine content (RNC) cigarettes, particularly as US regulators have permitted the sale of an RNC cigarette modified risk tobacco product (MRTP) that seeks further authorisation to advertise using modified risk claims. This study examined the effects of two advertising elements (product name and disclaimer content) on perceptions of an RNC cigarette MRTP. METHODS: Adult participants (n=807, 28.7% smokers, 58.2% male, 74.2% non-Latinx white) completed an online MTurk survey. Participants were randomised to view one of six RNC cigarette advertisements, using a 2×3 between-subject factorial design to manipulate product name ('Moonlight' vs 'Moonrise') and disclaimer content (industry-proposed: 'Nicotine is addictive. Less nicotine does NOT mean a safer cigarette' vs focused: 'Less nicotine does NOT mean a safer cigarette' vs no content), then completed recall and product perception questionnaires. RESULTS: All participants who viewed the industry-proposed disclaimer (vs no content) perceived greater addiction risk (p's<0.05). Non-smokers who viewed this disclaimer also perceived greater health risks and held fewer false beliefs (p's<0.05). Smokers who viewed Moonlight (vs Moonrise) ads perceived lower health risks (p<0.05). CONCLUSIONS: Disclaimer content may effectively inform consumers about addiction risk of a new RNC cigarette MRTP, and further inform non-smokers about health risks. This element, however, had little effect on perceived health risks among smokers, among whom the Moonlight product name was associated with health risk misperceptions similar to the banned 'light' descriptor.

Multiple Tobacco Product Use Conceptual Framework: A 2021 Update on Evidence.

INTRODUCTION: One-third of adults in the United States who use tobacco regularly use two or more types of tobacco products. As the use of e-cigarettes and other noncombusted tobacco products increases-making multiple tobacco product (MTP) use increasingly common-it is essential to evaluate the complex factors that affect product use. AIMS AND METHODS: In this update to our 2019 conceptual framework, we review and evaluate recent literature and expand the model to include ways in which MTP use may be affected by market factors such as the introduction of new products and socioenvironmental factors like marketing and advertising. RESULTS AND CONCLUSIONS: MTP use patterns are complex, dynamic, and multiply determined by factors at the level of individuals, products, situations or contexts, and marketplace. Substitution, or using one product with the intent of decreasing use of another, and complementarity, or using multiple products for different reasons or purposes, explain patterns in MTP use. Moreover, substitution and complementarity may inform our understanding of how market changes targeted at one product, for instance, new product standards, bans, product pricing, and taxation, affect consumption of other tobacco products. New data from natural experiments and novel laboratory-based techniques add additional data and expand the framework. IMPLICATIONS: A substantial proportion of people who use tobacco use more than one product. This review synthesizes and evaluates recent evidence on the diverse factors that affect MTP use in addition to expanding our framework. Our review is accompanied by suggested research questions that can guide future study.

Early Changes in Puffing Intensity When Exclusively Using Open-Label Very Low Nicotine Content Cigarettes.

INTRODUCTION: In response to reducing cigarette nicotine content, people who smoke could attempt to compensate by using more cigarettes or by puffing on individual cigarettes with greater intensity. Such behaviors may be especially likely under conditions where normal nicotine content (NNC) cigarettes are not readily accessible. The current within-subject, residential study investigated whether puffing intensity increased with very low nicotine content (VLNC) cigarette use, relative to NNC cigarette use, when no other nicotine products were available. AIMS AND METHODS: Sixteen adults who smoke daily completed two four-night hotel stays in Charleston, South Carolina (United States) in 2018 during which only NNC or only VLNC cigarettes were accessible. We collected the filters from all smoked cigarettes and measured the deposited solanesol to estimate mouth-level nicotine delivery per cigarette. These estimates were averaged within and across participants, per each 24-h period. We then compared the ratio of participant-smoked VLNC and NNC cigarette mouth-level nicotine with the ratio yielded by cigarette smoking machines (when puffing intensity is constant). RESULTS: Average mouth-level nicotine estimates from cigarettes smoked during the hotel stays indicate participants puffed VLNC cigarettes with greater intensity than NNC cigarettes in each respective 24-h period. However, this effect diminished over time (p < .001). Specifically, VLNC puffing intensity was 40.0% (95% CI: 29.9, 53.0) greater than NNC puffing intensity in the first period, and 16.1% (95% CI: 6.9, 26.0) greater in the fourth period. CONCLUSION: Average puffing intensity per cigarette was elevated with exclusive VLNC cigarette use, but the extent of this effect declined across four days. IMPLICATIONS: In an environment where no other sources of nicotine are available, people who smoke daily may initially attempt to compensate for cigarette nicotine reduction by puffing on individual cigarettes with greater intensity. Ultimately, the compensatory behavior changes required to achieve usual nicotine intake from VLNC cigarettes are drastic and unrealistic. Accordingly, people are unlikely to sustain attempts to compensate for very low cigarette nicotine content.

An Evaluation of Potential Unintended Consequences of a Nicotine Product Standard: A Focus on Drinking History and Outcomes.

INTRODUCTION: A nicotine product standard reducing the nicotine content in cigarettes could improve public health by reducing smoking. This study evaluated the potential unintended consequences of a reduced nicotine product standard by examining its effects on (1) smoking behaviors based on drinking history; (2) drinking behavior; and (3) daily associations between smoking and drinking. METHODS: Adults who smoke daily (n = 752) in the United States were randomly assigned to smoke very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC; control) cigarettes for 20 weeks. Linear mixed models determined if baseline drinking moderated the effects of VLNC versus NNC cigarettes on Week 20 smoking outcomes. Time-varying effect models estimated the daily association between smoking VLNC cigarettes and drinking outcomes. RESULTS: Higher baseline alcohol use (vs no use or lower use) was associated with a smaller effect of VLNC on Week 20 urinary total nicotine equivalents (ps < .05). No additional moderation was supported (ps > .05). In the subsample who drank (n = 415), in the VLNC versus NNC condition, daily alcohol use was significantly reduced from Weeks 17 to 20 and odds of binge drinking were significantly reduced from Weeks 9 to 17. By Week 7, in the VLNC cigarette condition (n = 272), smoking no longer predicted alcohol use but remained associated with binge drinking. CONCLUSIONS: We did not support negative unintended consequences of a nicotine product standard. Nicotine reduction in cigarettes generally affected smoking behavior for individuals who do not drink or drink light-to-moderate amounts in similar ways. Extended VLNC cigarette use may improve public health by reducing drinking behavior. IMPLICATIONS: There was no evidence that a VLNC product standard would result in unintended consequences based on drinking history or when considering alcohol outcomes. Specifically, we found that a very low nicotine standard in cigarettes generally reduces smoking outcomes for those who do not drink and those who drink light-to-moderate amounts. Furthermore, an added public health benefit of a very low nicotine standard for cigarettes could be a reduction in alcohol use and binge drinking over time. Finally, smoking VLNC cigarettes may result in a decoupling of the daily associations between smoking and drinking.

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Cross-Sectional Associations of Multiple Tobacco Product Use with Depressive and Anxiety Symptoms among Young Adult E-Cigarette Users.

BACKGROUND: Tobacco users with mental health conditions are a vulnerable population in tobacco research, yet few studies have evaluated the association of depressive and anxiety symptoms with multiple tobacco product (MTP) use among young adult electronic cigarette (ENDS) users. METHODS: Cross-sectional survey data on U.S. young adult past 30-day ENDS users (N = 2348) were collected via Amazon MTurk from May-July 2019. Binary logistic regressions evaluated the association of tobacco use pattern (exclusive ENDS use, ENDS + one other tobacco product [OTP; dual use], ENDS + two or more OTPs [poly-use]) with depressive (PHQ-9) and anxiety (GAD-7) symptoms. Among MTP users (n = 1736), we evaluated the association of ENDS use relative to OTP use and same-day MTP use with depressive and anxiety symptoms. RESULTS: The sample included 26% exclusive ENDS, 27% dual, and 47% poly-users. We observed a gradient-relationship for depressive and anxiety symptoms: poly-users had greater odds of depressive and anxiety symptoms compared to dual users (aOR = 1.86 [95%CI:1.50-2.30] and aOR = 1.61 [95%CI:1.30-2.01], respectively), and dual users had greater odds of depressive and anxiety symptoms compared to exclusive ENDS users (aOR = 1.42 [95%CI:1.11-1.81] and aOR = 1.56 [95%CI:1.20-2.02], respectively). MTP users who used ENDS more often than OTPs (vs. less often than OTPs) had greater odds of depressive (aOR = 1.38 [95%CI:1.06-1.80]) and anxiety (aOR = 1.37 [95%CI:1.04-1.79]) symptoms. CONCLUSIONS: The majority of young adult past 30-day ENDS users in this sample reported OTP use. Future research on MTP use should distinguish between dual and poly-use. Tobacco prevention efforts for young adults with mental health symptoms are needed.

Not Quite the Rule, But No Longer the Exception: Multiple Tobacco Product Use and Implications for Treatment, Research, and Regulation.

The patterns of tobacco product use in the United States have changed during the past several decades. Currently, a large proportion of tobacco users report using multiple tobacco products (MTPs). The prevalence of MTP use varies significantly by cigarette smoking frequency, as well: nearly half (46.9%) of all non-daily smokers report using other tobacco products within the past 30 days. Despite this, much of extant tobacco dependence treatment efforts, tobacco regulatory science research, and tobacco product research, in general, has focused largely on single product use (ie, cigarette smoking). To effectively design interventions and model the potential impact of regulations on tobacco products aimed at reducing tobacco use, as well as effectively study tobacco users, it is essential to consider actual use patterns in the population of tobacco users. Implications: MTP use is increasingly common in the United States. This commentary highlights the impact that MTP use has for efforts to treat tobacco dependence, tobacco regulatory science efforts, as well as on tobacco research, in general.

Cigarette Smoking Quit Rates Among Persons With Serious Psychological Distress in the United States From 2008 to 2016: Are Mental Health Disparities in Cigarette Use Increasing?

INTRODUCTION: Prior work suggests that the prevalence of cigarette smoking is persistently higher among people with mental health problems, relative to those without. Lower quit rates are one factor that could contribute to higher prevalence of smoking in this group. This study estimated trends in the cigarette quit rates among people with and without past-month serious psychological distress (SPD) from 2008 to 2016 in the United States. METHODS: Data were drawn from 91 739 adult participants in the 2008-2016 National Survey on Drug Use and Health, a repeated, cross-sectional, national survey. Linear time trends of cigarette quit rates, stratified by past-month SPD, were assessed using logistic regression models with continuous year as the predictor. RESULTS: Cigarette quit rates among individuals with past-month SPD were lower than among those without SPD every year from 2008 to 2016. Quit rates did not change appreciably among those with past-month SPD (odds ratio = 1.02 [0.99, 1.06]) from 2008 to 2016, whereas quit rates increased among those without past-month SPD (odds ratio = 1.02 [1.01, 1.02]). CONCLUSIONS: In the United States, quit rates among individuals with past-month SPD are approximately half than quit rates of those without SPD and have not increased over the past decade. This discrepancy in quit rates may be one factor driving increasing disparities in prevalence of smoking among those with versus without mental health problems. Tobacco control efforts require effective and targeted interventions for those with mental health problems. IMPLICATIONS: Cigarette smoking quit rates have not increased among persons with serious mental health problems over the past decade. This work extends prior findings showing that smoking prevalence is not declining as quickly among persons with serious mental health problems. Findings suggest that diverging trends in quit rates are one possible driver of the persistent disparity in smoking by mental health status. Innovation in both tobacco control and targeted interventions for smokers with mental health problems is urgently needed.

Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.

INTRODUCTION: We describe the development and pilot testing of the experimental tobacco and nicotine product marketplace (ETM)-a method for studying tobacco and nicotine product (TNP) choices and use behavior in a standardized way. AIMS AND METHODS: The ETM resembles an online store populated with TNPs. Surveillance activities and data from a US representative survey and consumer reports were used to determine the most popular TNPs for inclusion in the ETM. Standardized information and videos demonstrating how to use the TNPs were provided. To test the feasibility of using the ETM, smokers (n = 119) underwent monitoring of usual brand cigarette smoking and other TNP use (Baseline Phase) followed by access to the ETM (ETM Phase) that included their usual brand cigarettes, e-cigarettes, moist snuff, snus, and nicotine replacement therapy. During the ETM Phase, participants were provided points based on their baseline TNP consumption to exchange for TNPs in the ETM. Participants were advised to exchange points for enough TNPs to last until their next visit and to refrain from using TNPs not obtained in the ETM. A subset of the participants (n = 62) completed a survey on their experience with the ETM. RESULTS: The majority of the participants stated they were comfortable with navigating the ETM (97%), it was easy to determine product characteristics (89%), and they were satisfied with the products included in the marketplace (85%). CONCLUSIONS: The ETM was well received by the vast majority of the participants and can be utilized by researchers to investigate a variety of TNP policy and regulatory science research questions. IMPLICATIONS: Patterns of TNP use are complex due to greater availability, marketing, and promotion of a diverse array of TNPs. Innovative methods are needed to experimentally study TNP choices and patterns. Through describing the development of the ETM, we provide researchers with a tool that can be readily adapted to studying a variety of phenomena challenging public health.

Cigarette Smokers Versus Cousers of Cannabis and Cigarettes: Exposure to Toxicants.

INTRODUCTION: Cannabis and tobacco couse is common and could expose users to higher levels of toxicants. No studies have examined biomarkers of toxicant exposure in cousers of cannabis and cigarettes, compared with cigarette smokers (CS). AIMS AND METHODS: Adult daily CS were recruited from 10 US sites for a study of reduced nicotine cigarettes. In this analysis of baseline data, participants were categorized as either cousers of cannabis and tobacco (cousers; N = 167; urine positive for 11-nor-9-carboxy-Δ 9-tetrahydrocannnabinol and self-reported cannabis use ≥1×/week), or CS (N = 911; negative urine and no self-reported cannabis use). Participants who did not meet either definition (N = 172) were excluded. Self-reported tobacco and cannabis use and tobacco and/or combustion-related biomarkers of exposure were compared between groups. RESULTS: Compared to CS, cousers were younger (couser Mage = 38.96, SD = 13.01; CS Mage = 47.22, SD = 12.72; p < .001) and more likely to be male (cousers = 67.7%, CS = 51.9%, p < .001). There were no group differences in self-reported cigarettes/day, total nicotine equivalents, or breath carbon monoxide, but cousers had greater use of non-cigarette tobacco products. Compared to CS, cousers had higher concentrations of 3-hydroxypropylmercapturic acid, 2-cyanoethylmercapturic acid, S-phenylmercapturic acid, 3-hydroxy-1-methylpropylmercapturic acid (ps < .05), and phenanthrene tetraol (p < .001). No biomarkers were affected by number of cannabis use days/week or days since last cannabis use during baseline (ps > .05). CONCLUSIONS: Cousers had higher concentrations of biomarkers of exposure than CS, but similar number of cigarettes per day and nicotine exposure. Additional studies are needed to determine whether cannabis and/or alternative tobacco products are driving the increased toxicant exposure. IMPLICATIONS: Cousers of cannabis and tobacco appear to be exposed to greater levels of harmful chemicals (ie, volatile organic compounds and polycyclic aromatic hydrocarbons), but similar levels of nicotine as CS. It is unclear if the higher levels of toxicant exposure in cousers are due to cannabis use or the increased use of alternative tobacco products compared with CS. It is important for studies examining biomarkers of exposure among CS to account for cannabis use as it may have a significant impact on outcomes. Additionally, further research is needed examining exposure to harmful chemicals among cannabis users.

Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.

INTRODUCTION: Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period. AIMS AND METHODS: Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group. RESULTS: We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure. CONCLUSIONS: Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking. IMPLICATIONS: These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.

Cigarette smoking quit ratios among adults in the USA with cannabis use and cannabis use disorders, 2002-2016.

BACKGROUND: The prevalence of cigarette smoking is nearly three times higher among persons who use cannabis and have cannabis use disorders (CUDs), relative to those who do not. The current study examined cigarette quit ratios from 2002 to 2016 among US adults with and without cannabis use and CUDs. METHODS: The current study analysed US adults aged 18 years and older from the National Survey on Drug Use and Health, an annual cross-sectional study. Quit ratios (ie, proportion of former smokers among ever-smokers) were calculated annually from 2002 to 2016. Time trends in quit ratios by cannabis use/CUDs were tested using logistic regression. RESULTS: In 2016, the quit ratios for people with any cannabis use (23%) and CUDs (15%) were less than half the quit ratios of those without cannabis use and CUDs (51% and 48%, respectively). After controlling for demographics and substance use disorders, the quit ratio did not change from 2002 to 2016 among persons with CUD, though it non-linearly increased among persons with cannabis use, without cannabis use and without CUDs. Quit ratios increased more rapidly among those who reported past-month cannabis use compared with those without past-month cannabis use. CONCLUSIONS: Cigarette smoking quit ratios remain dramatically lower among people who use cannabis and have CUDs and quit ratios did not change significantly from 2002 to 2016 among those with CUDs. Public health and clinical attention are needed to increase quit ratios and reduce harmful cigarette smoking consequences for persons with cannabis use and CUDs.

Cigarette Use Among Individuals with Alcohol Use Disorders in the United States, 2002 to 2016: Trends Overall and by Race/Ethnicity.

BACKGROUND: Individuals with alcohol use disorders (AUDs) who smoke cigarettes experience greater health risks than those using either substance alone. Further, disparities exist in AUDs and smoking by race/ethnicity. Although smoking has declined in the general population, it is not known whether the smoking prevalence has changed over time for individuals with AUDs. The current study used representative U.S. data to estimate the prevalence of current cigarette use from 2002 to 2016 by AUD status and severity overall and by race/ethnicity. METHODS: Data were drawn from the National Survey on Drug Use and Health, an annual cross-sectional study of U.S. individuals, from 2002 to 2016 (total analytic sample n = 837,326). Cigarette smoking prevalence was calculated annually among those with and without past-year AUD and by AUD severity level (mild, moderate, severe AUD). Time trends in smoking prevalence by AUD status and severity were tested using logistic regression for the overall sample and significant interactions were subsequently stratified by race/ethnicity (non-Hispanic [NH] White, NH Black, Hispanic, NH Other). RESULTS: Cigarette use was persistently over twice as common among those with AUDs compared to without AUDs (2016: 37.84% vs. 16.29%). Cigarette use was also more common among those at each level of AUD severity criteria (2016: mild AUD 34.59%; moderate AUD 35.35%; severe AUD 52.23%). Approximately half of NH Black respondents with AUDs, and three-quarters of NH Black respondents with severe AUDs, reported smoking in 2016. The prevalence of smoking decreased significantly over time among respondents with and without AUDs; however, there were differences by race. There was no decline in smoking prevalence among NH Black respondents with AUDs over time in contrast to a significant decrease for every other racial/ethnic group with and without AUDs. CONCLUSIONS: Individuals with AUDs may need additional resources and interventions to quit smoking, especially NH Black individuals.

A Conceptual Framework for Understanding Multiple Tobacco Product Use and the Impact of Regulatory Action.

INTRODUCTION: Over 35% of the adult tobacco-using population regularly use more than one tobacco product. Although rates of tobacco use in the United States have declined over the last decade, rates of multiple tobacco product (MTP) have either remained stable (among adults) or increased (among youth). METHODS: In this paper, we review the literature and propose a framework for understanding both MTP use and how regulatory actions on any single tobacco product (STP) may influence the use of other tobacco products. RESULTS AND CONCLUSIONS: Within the framework, Product, Person, and Context/Situational factors (and their interactions) influence product cross-substitution and thus patterns of use of MTPs. In addition, we propose that Context/Situation effects specifically increase the complexity of MTP-use patterns resulting in "dynamic complementarity" in addition to substitution-like relationships between tobacco products. Experimentation with, and use of, various tobacco products results in reinforcement histories that affect which products are used, in what contexts, and by whom, which in turn has downstream impacts on toxicant exposure and health. We conclude our analysis with an examination of how regulation of STPs can have impacts on the use of other STP and MTP use and provide research questions for further examining MTP use. IMPLICATIONS: Though rates of tobacco use have declined in the United States, over 35% of the adult tobacco-using population regularly uses more than one tobacco product. This paper provides a framework for understanding MTP use and how regulatory actions on any STP may influence the use of other tobacco products. We conclude our analysis by providing research questions for further examining MTP use.

Anticipated Effects of Nicotine Reduction on Youth Smoking Initiation and Maintenance.

This commentary summarizes emerging findings on the potential impact of a nicotine reduction policy on youth and young adults. We conclude that: (1) adolescent smokers and nonsmokers alike are likely to be less sensitive to reinforcement from very low nicotine content (VLNC) cigarettes compared with adults; (2) reducing nicotine in cigarettes to 0.4 mg/g would reduce the abuse potential of cigarettes in adolescents and young adults; (3) findings to date do not support concerns that nicotine reduction leads to compensatory smoking in young smokers; and (4) if the scope of a reduced nicotine product standard were applied to all combusted tobacco products, that would likely maximize public health benefit of this policy.

Hookah Use Among US Youth: A Systematic Review of the Literature From 2009 to 2017.

INTRODUCTION: Given the US Food and Drug Administration (FDA)'s authority to regulate hookah, more research is needed to inform regulations intended to prevent youth from using hookah. This systematic review summarizes and assesses the literature related to hookah use among adolescents (11 to ≤18 years of age) in the United States from 2009 to 2017. METHODS: Database searches yielded 867 peer-reviewed articles. After duplicates were removed, authors reviewed 461 articles for inclusion. Included articles (n = 55) were coded for study themes, study quality, and their relevance to FDA's research priorities. A qualitative synthesis is presented. RESULTS: The following themes were identified: (1) prevalence of hookah use (n = 42), (2) tobacco use transitions (n = 7), (3) sociodemographic correlates (n = 35), (4) psychosocial risk factors (n = 21), (5) concurrent use of other tobacco products (n = 31), (6) concurrent use of other substances (n = 9), and (7) other (n = 15)-which includes low prevalence themes. The qualitative synthesis showed increasing rates of hookah use. Older age, male gender, positive social normative beliefs, higher peer use, as well as lower perceived risk were associated with hookah use. Longitudinal studies of youth hookah use showed bidirectional relationships between use of hookah and other tobacco products. All articles fell within FDA's research priority related to "behavior," and three priorities ("impact analysis," "health effects," and "toxicity") have not been explored for hookah use among US youth since 2009. CONCLUSIONS: The prevalence of hookah use among youth in the United States is increasing, thus more research is needed to inform policies targeted to protect this vulnerable population. IMPLICATIONS: This study represents a novel contribution to our understanding of hookah use among youth in the United States from 2009-the year that the Family Smoking Prevention and Tobacco Control Act was passed-to 2017. In recent years, hookah has become a more popular tobacco product among US youth; however, to date, no systematic reviews of hookah use among this population exist. Results highlight implications for future US FDA regulatory policy and identify gaps in research to be addressed in future studies.

Effects of Very Low Nicotine Content Cigarettes on Smoking Behavior and Biomarkers of Exposure in Menthol and Non-menthol Smokers.

INTRODUCTION: Because 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a nicotine reduction policy. METHODS: In a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence. RESULTS: At baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps < .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition. CONCLUSIONS: Although menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers. IMPLICATIONS: Results of this analysis suggest that smokers of menthol cigarettes may respond to a nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes.

The Impact of Gradual and Immediate Nicotine Reduction on Subjective Cigarette Ratings.

BACKGROUND: A recent clinical trial showed that an immediate transition to very low nicotine content (VLNC) cigarettes, compared with a gradual transition, produced greater reductions in smoking behavior, smoke exposure, and dependence. However, there was less compliance with the instruction to smoke only VLNC cigarettes in the immediate versus gradual reduction condition. The goal of this study was to test whether nicotine reduction method alters subjective ratings of VLNC cigarettes, and whether subjective ratings mediate effects of nicotine reduction method on smoking behavior, smoke exposure, dependence, and compliance. METHODS: This is a secondary analysis of a randomized trial conducted across 10 sites in the United States. Smokers (n = 1250) were randomized to either a control condition, or to have the nicotine content of their cigarettes reduced immediately or gradually to 0.04 mg nicotine/g of tobacco during a 20-week study period. Participants completed the modified Cigarette Evaluation Questionnaire (mCEQ). RESULTS: After Week 20, the immediate reduction group scored significantly lower than the gradual reduction group on multiple subscales of the mCEQ (ps < .001). The Satisfaction subscale of the mCEQ mediated the impact of nicotine reduction method on smoke exposure, smoking behavior, dependence, compliance, and abstinence. Other subscales also mediated a subset of these outcomes. CONCLUSIONS: An immediate reduction in nicotine content resulted in lower product satisfaction than a gradual reduction, suggesting that immediate reduction further reduces cigarette reward value. This study will provide the Food and Drug Administration with information about the impact of nicotine reduction method on cigarette reward value. IMPLICATIONS: These data suggest that an immediate reduction in nicotine content will result in greater reductions in cigarette satisfaction than a gradual reduction, and this reduction in satisfaction is related to changes in smoking behavior and dependence.

Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes.

BACKGROUND: The US Food and Drug Administration recently issued an advanced notice of proposed rule-making for reducing the nicotine content in cigarettes to a minimally addictive level. Very little is known about whether use of very low nicotine content (VLNC) cigarettes affects support for a nicotine reduction policy. OBJECTIVE: This study examined the effects of using VLNC versus usual brand (UB) cigarettes on support for a nicotine reduction policy and determined whether participant characteristics and responses to VLNC cigarettes were associated with policy support. METHODS: Participants from a cigarette trial who were assigned to either 0.4 mg nicotine/g tobacco research cigarettes or their UB for 6 weeks were asked about their support for the policy. χ2 tests were used to compare support for the policy between cigarette conditions and logistic regression analyses were conducted to assess covariates associated with policy support. FINDINGS: Policy support did not differ by condition. After 6 weeks of using VLNC cigarettes, 50% of participants supported the policy, 26% opposed and 24% responded 'Don't Know'. Support was higher among those adherent to smoking only VLNC cigarettes (65%) compared with those who were non-adherent (44%). Older participants and those interested in quitting had increased odds of support. Cigarette satisfaction, perceived harm and perceived nicotine content were not significantly associated with support. CONCLUSIONS: Smoking VLNC cigarettes did not affect support for a nicotine reduction policy. Understanding predictors of policy support and opposition will help public health officials to maximise the public health acceptance and impact of this policy (ClinicalTrials.gov Identifier: NCT01681875 Post-Results).

Young adult dual combusted cigarette and e-cigarette users' anticipated responses to hypothetical e-cigarette market restrictions.

Introduction: The aim of this exploratory study was to assess young adult dual e-cigarette (EC) and combusted cigarette (CC) users' anticipated responses to hypothetical market restrictions regarding key EC characteristics. Methods: Data came from 240 young adult dual EC and CC users recruited via Amazon Mechanical Turk in June 2017. Descriptive statistics were used to report sociodemographic, CC smoking, and EC use characteristics. McNemar's chi-square tests and chi-square tests were used to assess differences between groups in terms of anticipated responses to hypothetical EC market restrictions. Results: Hypothetical regulations resulted in reported intentions to reduce EC use and increase CC use; the greatest impact was found for restrictions regarding e-liquid nicotine content, followed by flavor and ability to modify EC devices. Moreover, individuals reporting use of flavored e-liquid, high nicotine content e-liquid, and customizable EC were most likely to report intentions to reduce EC use and increase CC use. Conclusions: This work provides preliminary evidence that restrictive regulations regarding key EC characteristics may increase intentions to increase CC use among young adult dual EC and CC users.