The Impact of Three Alternate Nicotine-Delivery Products on Combusted Cigarette Use: A Randomized Controlled Trial.

INTRODUCTION: Smoking cessation is a critical public health goal. This study examined the ability of e-cigarettes and very low nicotine cigarettes (VLNCs) to serve as cigarette substitutes and whether a substitution was supported by steady-state nicotine from a nicotine patch. AIMS AND METHODS: This mixed design experiment with study product (between-subjects) and patch (within-subjects) factors recruited adults smoking cigarettes daily and not motivated to quit (N = 160). Participants were randomized to 4 weeks of: (1) VLNCs; (2) e-cigarettes; or (3) no product. During two switch weeks, one with an active nicotine patch and one with a placebo patch (in a double-blind and counterbalanced fashion), participants were told to not smoke their usual cigarettes. RESULTS: During the switch weeks, participants in the VLNC (M = 2.88, SD = .65) and e-cigarette (M = 3.20, SD = .63) groups smoked fewer of their own cigarettes per day than did no product group participants who continued to smoke their own cigarettes (M = 5.48, SD = .63); the VLNC and e-cigarette groups did not differ. There was no main effect of patch on mean usual brand cigarettes smoked per day (P = .09), nor was there a product × patch interaction (P = .51). There was a product × age interaction (P = .03); smokers aged 60-74 smoked more of their own cigarettes if they were randomized to no product group. CONCLUSIONS: VLNCs and e-cigarettes appear to reduce usual brand cigarettes smoked per day to a similar degree, regardless of patch condition. Behavioral factors, in addition to nicotine dependence, play an important role in sustaining smoking behavior and need to be addressed in smoking cessation treatment. IMPLICATIONS: This study found that behavioral substitutes for cigarettes, whether or not they delivered nicotine, reduced the number of usual brand cigarettes smoked. Specifically, both e-cigarettes delivering nicotine and VLNCs equally reduce usual brand cigarettes smoked among adults who smoke daily and do not want to quit.

Effect of nicotine corrective messaging on nicotine-related beliefs in US adults: a randomised controlled trial.

INTRODUCTION: Widespread misperceptions of the health risks of nicotine could undermine the public health benefits of the Food and Drug Administration's actions, including modified risk tobacco product authorisations and a reduced nicotine product standard for cigarettes. METHODS: 794 US adults (aged 18+) in NORC's AmeriSpeak panel participated in a randomised controlled trial in Spring 2021 to test the effect of three exposures to eight nicotine corrective messages (NCM) on beliefs about nicotine, nicotine replacement therapy (NRT), e-cigarettes and reduced nicotine content (RNC) cigarettes at 3-month follow-up. Analyses conducted in 2022 examined the effect of study condition (NCM (n=393) vs no message control (n=401)) on nicotine beliefs, use intentions and use of nicotine and tobacco products. RESULTS: Exposure to three NCM doses reduced nicotine (b=-0.33; 95% CI -0.60, -0.07), NRT (b=-0.49; 95% CI -0.85, -0.14), e-cigarette (b=-0.32; 95% CI -0.59, -0.05) and RNC cigarette false beliefs (b=-0.64; 95% CI -1.26, -0.02) compared with the control, controlling for baseline beliefs. Baseline tobacco use and concern about nicotine addiction attenuated intervention effects on false beliefs about RNC cigarettes. There were few intervention effects on intention or use of nicotine and tobacco products. CONCLUSIONS: Repeated exposure to NCM was necessary to reduce false beliefs about nicotine and tobacco products. Future studies will improve understanding of the dose and duration of nicotine education needed to shift intentions and behaviour, as well as tailored content for tobacco product users to achieve similar reductions in false beliefs as non-users. TRIAL REGISTRATION NUMBER: NCT04805515.

Monitoring the Implementation of Tobacco Cessation Support Tools: Using Novel Electronic Health Record Activity Metrics.

BACKGROUND: Clinical decision support (CDS) tools in electronic health records (EHRs) are often used as core strategies to support quality improvement programs in the clinical setting. Monitoring the impact (intended and unintended) of these tools is crucial for program evaluation and adaptation. Existing approaches for monitoring typically rely on health care providers' self-reports or direct observation of clinical workflows, which require substantial data collection efforts and are prone to reporting bias. OBJECTIVE: This study aims to develop a novel monitoring method leveraging EHR activity data and demonstrate its use in monitoring the CDS tools implemented by a tobacco cessation program sponsored by the National Cancer Institute's Cancer Center Cessation Initiative (C3I). METHODS: We developed EHR-based metrics to monitor the implementation of two CDS tools: (1) a screening alert reminding clinic staff to complete the smoking assessment and (2) a support alert prompting health care providers to discuss support and treatment options, including referral to a cessation clinic. Using EHR activity data, we measured the completion (encounter-level alert completion rate) and burden (the number of times an alert was fired before completion and time spent handling the alert) of the CDS tools. We report metrics tracked for 12 months post implementation, comparing 7 cancer clinics (2 clinics implemented the screening alert and 5 implemented both alerts) within a C3I center, and identify areas to improve alert design and adoption. RESULTS: The screening alert fired in 5121 encounters during the 12 months post implementation. The encounter-level alert completion rate (clinic staff acknowledged completion of screening in EHR: 0.55; clinic staff completed EHR documentation of screening results: 0.32) remained stable over time but varied considerably across clinics. The support alert fired in 1074 encounters during the 12 months. Providers acted upon (ie, not postponed) the support alert in 87.3% (n=938) of encounters, identified a patient ready to quit in 12% (n=129) of encounters, and ordered a referral to the cessation clinic in 2% (n=22) of encounters. With respect to alert burden, on average, both alerts fired over 2 times (screening alert: 2.7; support alert: 2.1) before completion; time spent postponing the screening alert was similar to completing (52 vs 53 seconds) the alert, and time spent postponing the support alert was more than completing (67 vs 50 seconds) the alert per encounter. These findings inform four areas where the alert design and use can be improved: (1) improving alert adoption and completion through local adaptation, (2) improving support alert efficacy by additional strategies including training in provider-patient communication, (3) improving the accuracy of tracking for alert completion, and (4) balancing alert efficacy with the burden. CONCLUSIONS: EHR activity metrics were able to monitor the success and burden of tobacco cessation alerts, allowing for a more nuanced understanding of potential trade-offs associated with alert implementation. These metrics can be used to guide implementation adaptation and are scalable across diverse settings.

Qualitative reactions to a low nicotine product standard for cigarettes from adolescents and young adults living in the United States who smoke.

The Biden Administration is considering a low nicotine product standard for cigarettes. This qualitative study examined reactions to a nicotine reduction policy among adolescents and young adults (AYA) who smoke cigarettes. After completing a lab study involving masked exposure either to low nicotine or normal nicotine research cigarettes and unmasked exposure to e-cigarettes varying in nicotine concentration and flavor, we conducted follow-up semi-structured interviews (N = 25) to explore participants' knowledge, attitudes, and perceptions of a low nicotine product standard and their anticipated tobacco use behavior after policy implementation. Interviews were audio-recorded, transcribed verbatim, double-coded, and analyzed using reflexive thematic analysis. Nearly half of participants supported the policy because they thought it would prevent young people from starting smoking and/or would help people quit. Reasons some participants opposed the policy included beliefs that adults should have the choice to smoke or that a nicotine reduction policy is counterintuitive because the government benefits from cigarette sales. Others believed the policy would be ineffective because youth could circumvent the policy (e.g., illicit market) or would increase their smoking to maintain the same nicotine level. Almost half of participants said they would quit smoking while the other half said they would continue smoking, although potentially reduce their smoking. Overall, our qualitative findings point to the need for pre-policy media campaigns targeting AYA who smoke to minimize negative reactions, dispel fears, and correct misperceptions as well as encourage quitting and provide information on accessing cessation resources.

The impact of the COVID-19 pandemic on a sample of US young adults who smoke cigarettes: A qualitative analysis.

INTRODUCTION: The ongoing COVID-19 pandemic has been associated with increased negative mood in youth, and a few reports of changes in tobacco use. We sought to increase the depth of knowledge on the effects of the pandemic on early young adult mood states, access to tobacco products and tobacco use behaviors, and knowledge of risks associated with tobacco use and COVID-19 by learning more about the lived experience of the pandemic among young adults early in their smoking trajectories. METHODS: Semi-structured qualitative interviews were conducted with 25 young adults ages 18-20 (M = 19) who smoked cigarettes daily or nearly every day and had used electronic cigarettes (ECs) on ≥ 2 occasions in their lifetime. RESULTS: Our results uncovered several themes: 1) The majority of teens experienced mental health disturbances as a result of the pandemic, which manifested as depression, anxiety, and/or acute loneliness due to social isolation; 2) tobacco purchasing behaviors sometimes changed, with both greater and less access reported among participants; 3) changes in tobacco use were also reported, with some reporting increases in use, others reporting decreases, and a few reporting quitting; and 4) while some youth reported that tobacco use could increase their risk related to COVID-19, the majority reported confusion and uncertainty about how tobacco use impacted their risk. CONCLUSIONS: The themes identified specific factors that may account for the heterogeneity of impacts of the pandemic on tobacco use, and highlight the value of qualitative work for centering the lived experience of youth for understanding larger trends in substance use.

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.

Biochemical validation of self-reported electronic nicotine delivery system and tobacco heaviness of use.

Research on tobacco use disorder relies on a combination of self-reported use (e.g., cigarettes per day) and biochemical validation to quantify heaviness of use. However, electronic nicotine delivery system (ENDS) users may be unaware of how much they have vaped per day. The aim of this study was to test the relationship between self-reported heaviness of ENDS/tobacco use and nicotine biomarkers. Young adults (n = 30) who currently use ENDS and other tobacco products completed a detailed tobacco use history, timeline follow-back, and an ENDS topography session. We evaluated the self-reports of own-brand ENDS use and tested correlations to determine which self-report measures of own-brand use, and which self-reported measures of puff topography, had the strongest correlations with urine and/or blood biomarkers of nicotine use. Participants reported using a variety of different ENDS devices and had a range of usage. The sum of the self-reported number of occasions or hours of ENDS use, along with the number of cigarettes and other tobacco products used, over the past 24 hr was significantly correlated with plasma cotinine levels. Puff topography measures correlated with increased nicotine concentrations, although participants underestimated the number of puffs they took during the topography session. This study provides preliminary evidence that summing together the hours of ENDS use, or the number of occasions of ENDS use, in addition to the number of other tobacco products used (i.e., cigarettes) based on self-report may be an accurate method of quantification. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Elucidating the reinforcing effects of nicotine: a tribute to Nadia Chaudhri.

Nadia Chaudhri worked with us as a graduate student in the Center for Neuroscience at the University of Pittsburgh from 1999 until she earned her PhD in 2005, a time that coincided with the discovery in our lab of the dual reinforcing actions of nicotine, a concept that she played an important role in shaping. The research that was described in her doctoral thesis is among the foundational pillars of the now well-accepted notion that nicotine acts as both a primary reinforcer and an amplifier of other reinforcer stimuli. This reinforcement-enhancing action of nicotine is robust and likely to be a powerful driver of nicotine use. Below, we discuss the evidence that these two actions of nicotine - primary reinforcement and reinforcement enhancement - are distinct and dissociable, a finding that Nadia was closely associated with. We go on to address two other topics that greatly interested Nadia during that time, the generalizability of the reinforcement-enhancing action of nicotine to multiple classes of reinforcing stimuli and potential sex differences in the dual reinforcing actions of nicotine. The research has greatly expanded since Nadia's involvement, but the core ideas that she helped to develop remain central to the concept of the dual reinforcing actions of nicotine and its importance for understanding the drivers of nicotine use.

Immediate Switching to Reduced Nicotine Cigarettes in a U.S.-Based Sample: The Impact on Cannabis Use and Related Variables at 20 Weeks.

INTRODUCTION: The FDA proposed rule-making to reduce nicotine in cigarettes to minimally addictive levels. Research suggests decreasing nicotine levels (i.e. very low nicotine content cigarettes [VLNCs]) produced greater quit attempts, reduced smoking, and reduced exposure to harmful constituents among smokers. The impact of long-term VLNC use among people who co-use cigarettes and cannabis on non-tobacco-specific toxicant and carcinogen exposure has not been investigated. AIMS AND METHODS: This study presents secondary analyses of a controlled clinical trial examining switching to VLNC (versus a normal nicotine cigarettes control group [NNCs]) between people who co-use cigarettes and cannabis (n = 174) versus smoked cigarettes (n = 555). Linear mixed-effects models compared changes in smoking behavior, and tobacco-specific (i.e. total nicotine equivalents [TNE], 4-[methylnitrosamino]-1-[3-pyridyl]-1-butanone [NNK; total NNAL]) and non-tobacco-specific (i.e. carbon monoxide (CO), 2-cyanoethylmercapturic acid [CEMA], phenanthrene tetraol [PheT]) toxicant and carcinogen exposure at week 20 (with random intercept for participants). Cannabis use was measured among co-use groups. RESULTS: CO was significantly lower only among the cigarette-only group assigned VLNCs (interaction: p = .015). Although both VLNC groups demonstrated decreased CEMA, greater decreases emerged among the cigarette-only group (interaction: p = .016). No significant interactions emerged for TNE, cigarettes per day (CPD), NNAL, and PheT (ps > .05); both VLNC groups decreased in TNE, CPD, and NNAL. Only the cigarette-only group assigned VLNCs demonstrated decreased PheT (p < .001). The VLNC co-use group showed increased cannabis use over time (p = .012; 0.5 more days per week by week 20). CONCLUSIONS: Those who co-use cannabis and cigarettes may still be at risk for greater exposure to non-tobacco-specific toxicants and carcinogens compared to those who only smoke cigarettes. IMPLICATIONS: The present study is the longest longitudinal, prospective comparison study of smoking behavior and exposure to harmful constituents among those who co-use cigarettes and cannabis versus cigarette-only after immediately switching to very low nicotine content cigarettes (VLNC). Those who co-use experienced similar reductions in CPD and tobacco-specific exposure, compared to those who only use cigarettes. However, co-use groups experienced smaller reductions in non-tobacco-specific toxicants and carcinogens compared to the cigarette-only group, potentially because of combustible cannabis use. Additionally, those who co-use and switched to VLNC may be susceptible to slight increases in cannabis use (approximately two more days per year).

Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes.

INTRODUCTION: The Food and Drug Administration (FDA) announced its intention to reduce the nicotine content in cigarettes as a strategy to promote cessation and reduce smoking-related harm. A low nicotine product standard will apply to all cigarettes on the market, including menthol cigarettes. In December 2021, the FDA approved a modified risk tobacco product application for menthol and non-menthol flavoured very low nicotine cigarettes (VLNC) from the 22nd Century Group. Notably, experimentation with menthol cigarettes is linked to smoking progression, as well as greater nicotine dependence relative to non-menthol cigarette use. If menthol VLNCs are perceived as more appealing than non-menthol VLNCs, this would indicate that some aspect of menthol may maintain smoking even in the absence of nicotine and FDA's regulatory authority to ban or restrict the sale of menthol cigarettes should apply to reduced nicotine content of cigarettes. In April 2022, the FDA announced proposed rulemaking to prohibit menthol cigarettes, however it is unclear if a menthol prohibition would apply to VLNCs. METHODS AND ANALYSIS: This study will recruit 172 young adult menthol smokers (with a specific subsample of n=40 sexual and gender minority young adults) and measure appeal for smoking experimental menthol and non-menthol VLNCs, and the impact of proposed product standards on tobacco product purchasing behaviour using an Experimental Tobacco Marketplace. Appeal across product standards will be assessed in a controlled laboratory and using ecological momentary assessment. ETHICS AND DISSEMINATION: The protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#11865). Findings will examine the effects of a reduced nicotine standard and a menthol ban on young adult smoking and will be disseminated through peer-reviewed journal articles and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: NCT04340947.

Cigarette filter ventilation, smoking topography, and subjective effects: A mediational analysis.

BACKGROUND: Filter ventilation in cigarettes has been associated with alterations in smoking topography in order to compensate for the lower nicotine yields. Subjective effects of cigarettes include sensations, which can be affected by how a person smokes a cigarette. We look at smoking topography as a mediator in the relationship between filter ventilation levels and subjective effects. METHODS: Smoking topography and subjective effects data come from the baseline usual cigarette brand laboratory visits of participants (N = 607) in a randomized clinical trial on reduced nicotine cigarettes. Conditional process analysis was done using PROCESS macro version 3.5 in SPSS. RESULTS: There was a positive indirect effect of ventilation on satisfaction through total puff volume (0.004, 95% CI: 0.002, 0.007]) as well as ventilation on satisfaction through puff count then total puff volume, sequentially (0.001, 95% CI: [0.000, 0.003]). There was a positive indirect effect of ventilation on enjoyment through puff count for individuals less than 43 years of age (0.01, 95% CI: [0.002, 0.013]). There was a positive indirect effect of ventilation on enjoyment through total puff volume for individuals who smoke less than 14.33 cigarettes per day (0.009, 95% CI: [0.004, 0.015]). CONCLUSIONS: We found preliminary evidence that topography measures (puff count and total puff volume), mediate the relationship between filter ventilation and specific subjective effects of smoking (satisfaction and enjoyment). Age and cigarettes smoked per day moderated these relationships. These results could have implications regarding filter ventilation restrictions and smokers' perceptions of using such cigarettes.

Monoamine oxidase inhibition in cigarette smokers: From preclinical studies to tobacco product regulation.

Monoamine oxidase (MAO) activity is reduced in cigarette smokers and this may promote the reinforcing actions of nicotine, thereby enhancing the addictive properties of cigarettes. At present, it is unclear how cigarette smoking leads to MAO inhibition, but preclinical studies in rodents show that MAO inhibition increases nicotine self-administration, especially at low doses of nicotine. This effect of MAO inhibition develops slowly, likely due to plasticity of brain monoamine systems; studies relying on acute MAO inhibition are unlikely to replicate what happens with smoking. Given that MAO inhibition may reduce the threshold level at which nicotine becomes reinforcing, it is important to consider this in the context of very low nicotine content (VLNC) cigarettes and potential tobacco product regulation. It is also important to consider how this interaction between MAO inhibition and the reinforcing actions of nicotine may be modified in populations that are particularly vulnerable to nicotine dependence. In the context of these issues, we show that the MAO-inhibiting action of cigarette smoke extract (CSE) is similar in VLNC cigarettes and cigarettes with a standard nicotine content. In addition, we present evidence that in a rodent model of schizophrenia the effect of MAO inhibition to enhance nicotine self-administration is absent, and speculate how this may relate to brain serotonin systems. These issues are relevant to the MAO-inhibiting effect of cigarette smoking and its implications to tobacco product regulation.

Preliminary evidence on cigarette nicotine reduction with concurrent access to an e-cigarette: Manipulating cigarette nicotine content, e-liquid nicotine content, and e-liquid flavor availability.

The reinforcing characteristics of e-cigarettes could moderate the impact of reducing cigarette nicotine content. In this study, people who smoke daily were recruited from North Carolina and Pennsylvania (US) in 2018 and 2019. Within a randomized 2 × 2 × 2 factorial design, participants received investigational cigarettes and an e-cigarette for 12 weeks. Cigarette nicotine content was very low (0.4 mg/g of tobacco; VLNC) or normal (15.8 mg/g; NNC). E-liquids were 0.3% ("low") or 1.8% ("moderate") freebase nicotine, and available in tobacco flavors or tobacco, fruit, dessert and mint flavors. Study recruitment concluded before reaching the planned sample size (N = 480). Fifty participants were randomized and 32 completed the study. We found that randomization to VLNC, relative to NNC cigarettes, reduced self-reported cigarettes per day (CPD; mean difference: -12.96; 95% CI: -21.51, -4.41; p = 0.005); whereas e-liquid nicotine content and flavor availability did not have significant effects. The effect of cigarette nicotine content was larger in the moderate vs. low nicotine e-liquid groups and in the all flavors versus tobacco flavors e-liquid groups; tests of the interaction between e-liquid characteristics and cigarette nicotine content were not significant. Biomarkers of smoke exposure at Week 12 did not differ across conditions, which may reflect variability in adherence to only using VLNC cigarettes. In conclusion this study offers preliminary evidence that the extent to which cigarette nicotine reduction decreases smoking may depend on the reinforcing characteristics of alternative products, including the available nicotine contents and flavors of e-cigarettes.

Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes.

The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

Centering racial justice for Black/African American and Indigenous American people in commercial tobacco product regulation.

Although overall health in the United States (US) has improved dramatically during the past century, long-standing health inequities, particularly the unequal and unjust burden of tobacco-related disease and death among racialized populations, persist. A considerable gap exists in our understanding of how commercial tobacco product regulations and policies cause and/or exacerbate race-based health inequities among Black/African American (B/AA) and Indigenous American people. The purpose of this paper is to 1) describe how existing US commercial tobacco regulatory policies may contribute to structural racism and undermine the full benefits of tobacco prevention and control efforts among B/AA and Indigenous American groups; and 2) initiate a call to action for researchers and regulators of tobacco products to examine policies using an equity lens. These actions are imperative if empirically-informed regulation of commercial tobacco products is to address health equity.

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.

A Bayesian hierarchical model for individual participant data meta-analysis of demand curves.

Individual participant data meta-analysis is a frequently used method to combine and contrast data from multiple independent studies. Bayesian hierarchical models are increasingly used to appropriately take into account potential heterogeneity between studies. In this paper, we propose a Bayesian hierarchical model for individual participant data generated from the Cigarette Purchase Task (CPT). Data from the CPT details how demand for cigarettes varies as a function of price, which is usually described as an exponential demand curve. As opposed to the conventional random-effects meta-analysis methods, Bayesian hierarchical models are able to estimate both the study-specific and population-level parameters simultaneously without relying on the normality assumptions. We applied the proposed model to a meta-analysis with baseline CPT data from six studies and compared the results from the proposed model and a two-step conventional random-effects meta-analysis approach. We conducted extensive simulation studies to investigate the performance of the proposed approach and discussed the benefits of using the Bayesian hierarchical model for individual participant data meta-analysis of demand curves.

"I think it's a good idea for the people that's young, the kids, but for someone like me it's a bad idea." - Interviews about a U.S. menthol cigarette ban with people who smoke menthol cigarettes.

OBJECTIVE: The US Food and Drug Administration recently announced its intention to pursue a federal ban on menthol cigarettes. This qualitative study assessed reactions to a potential menthol cigarette ban among people who smoke menthol cigarettes. METHODS: As part of a laboratory study examining menthol flavor regulations, we conducted follow-up interviews with participants who smoke menthol cigarettes (N = 35). We explored the following topics: (1) menthol cigarette risk perceptions; (2) knowledge, attitudes, and perceptions of menthol cigarette regulations; and (3) anticipated behavior if menthol cigarettes were banned. Interviews were audio-recorded, transcribed verbatim, double-coded, and analyzed using reflexive thematic analysis. RESULTS: Many participants thought menthol cigarettes carried more health risks than non-menthol cigarettes. Some participants said regulators wanted to ban menthol cigarettes because they appeal to youth. Others thought a ban would be good for public health because fewer people, particularly youth, would smoke. Several voiced skepticism about banning only menthol cigarettes rather than all cigarettes. Most said they would use other products, including electronic cigarettes or non-menthol cigarettes, but many also thought a menthol ban could motivate them or others to quit smoking. CONCLUSIONS: Banning menthol cigarettes could lead some people who smoke menthol cigarettes to switch to potentially less harmful products, like e-cigarettes, or quit smoking, which would likely benefit public health; however, others may simply transition to non-menthol cigarettes. As regulators move forward with banning menthol cigarettes, communication campaigns explaining the public health benefits, potentially focusing on the benefits for youth, should be part of the policy implementation plan.

Educating the Public on the Health Risks of Very Low Nicotine Content Cigarettes: Results From a US-Based Convenience Sample.

INTRODUCTION: US FDA issued an advance notice of proposed rulemaking to reduce nicotine in cigarettes. To maximize the benefits of this potential standard, very low nicotine content (VLNC) cigarettes must be communicated in a way that does not result in misperceptions. AIMS AND METHODS: Adults (n = 567 who smoke; n = 610 non-smokers) from an online platform were randomized to a control message previously associated with accurate addictiveness perceptions of VLNC cigarettes but health misperceptions or to one of five messages that also included messaging on nicotine morbidity effects or VLNC cigarettes morbidity or mortality effects. p value <.01 was significant. RESULTS: In participants who smoke, perceived lung cancer risk (responses: 1, very little risk to 10, very high risk) if smoked VLNC cigarettes regularly was higher in conditions that communicated mortality effects of VLNC cigarettes compared to the control (7.12-7.18 vs. 5.97, p values < .01). In non-smokers, perceived lung cancer risk was higher in all five message conditions when compared with the control (7.58-8.22 vs. 6.35, p values < .01). Proportion who responded accurately (ie, False) to the statement Cigarettes with 95% less nicotine are safer than cigarettes with normal nicotine levels was higher in conditions describing VLNC morbidity or mortality effects when compared with the control in both participants who smoke (52.04-67.37% vs. 30.85%, p values < .01) and do not smoke (62.50-72.38% vs. 32.00%, p values < .01). CONCLUSIONS: Messaging on mortality effects of VLNC cigarettes (ie, cigarettes with 95% less nicotine are as deadly as current cigarettes) was associated with more accurate perceptions of the health risks of VLNC cigarettes than the control; however, misperceptions remained in one-third of participants. IMPLICATIONS: One approach to communicating a VLNC cigarette standard to the public is to include messaging on the mortality effects of VLNC cigarettes. However, further study and possible refinement of this message condition are recommended since approximately one-third of participants exposed to this message still perceived VLNC cigarettes to be safer than normal nicotine content cigarettes.

A review of the evidence on cigarettes with reduced addictiveness potential.

BACKGROUND: In May 2018, the Secretariat for the World Health Organization Framework Convention on Tobacco Control convened a meeting to discuss the potential for reducing the addictiveness of tobacco products. A central focus was to review research findings on the behavioral effects of reducing the addictiveness of cigarettes. METHODS: This manuscript reports the results of a review of the behavioral science literature, updated through April 2021, with special attention to both the potential benefits and unintended consequences of reducing nicotine in cigarettes. RESULTS: Available evidence suggests that reducing nicotine content in cigarettes to very low levels could benefit public health in three primary ways, by 1) decreasing uptake of regular smoking, 2) decreasing the amount people smoke, and 3) increasing the likelihood of smoking cessation. Current evidence also suggests that reducing nicotine in cigarettes may produce similar benefits across many important subpopulations of people who smoke, including those with psychiatric comorbidities, those who use other substances, those with low socioeconomic status, young people, people who smoke infrequently and people who prefer menthol cigarettes. Cigarette nicotine reduction could also lead to some undesirable outcomes, such as experiencing withdrawal, product manipulation, an illicit market, and harm misperceptions; strategies that may mitigate each are discussed. CONCLUSION: Overall, behavioral research suggests product standards that limit the nicotine content of combusted tobacco products could render cigarettes and similar products less addictive. The availability of legal, non-combusted products that effectively substitute for cigarettes and the dissemination of public health campaigns that clarify misperceptions about the relationship between nicotine, tobacco and disease may facilitate the extent to which a nicotine reduction policy reduces smoking.