The prospective relationship between a-priori intentions for and patterns of e-cigarette use among adults who smoke cigarettes.

BACKGROUND: Electronic (e-)cigarettes may help adult cigarette smokers achieve cigarette cessation, depending on patterns of e-cigarette use. Among cigarette smokers who do not use e-cigarettes, it is unclear if and how a-priori intentions for use are related to uptake patterns. Longitudinal studies have focused on established e-cigarette users or adolescent and young adult populations exclusively. METHODS: Within a nationwide randomized clinical trial (N = 638), adult cigarette smokers not currently using e-cigarettes were randomized (2:1) to receive (or not) one-month sampling of e-cigarettes. An exploratory factor analysis (EFA) was performed on an established 15-item measure assessing a-priori intentions for e-cigarette use to identify latent variables. Among those receiving e-cigarette products, regression models examined relationships between intentions and: 1) uptake (yes/no), 2) frequency (number of days per week), and 3) amount (puffing episodes per day) of e-cigarette use at one-month follow-up. RESULTS: Two factors emerged from the EFA: 1) cigarette-related intentions (e.g., cigarette cessation, no smell) and 2) novel appeal of e-cigarettes (e.g., flavors). Three items remained and were treated as separate intentions: "feels like cigarette smoking", "curiosity", and "affordability". In the final multivariable models, "feel like cigarette smoking" predicted more frequent e-cigarette use (ß = 0.187, SE = 0.086, p = 0.03); however, none of the five factors/intentions were significantly associated with uptake or amount of use. CONCLUSIONS: For adult cigarette smokers not currently using e-cigarettes, a-priori intentions for using e-cigarettes might not be predictive of if or how these products will be used in the future, suggesting that motives may not drive use behavior.

Shift From Smoking Cigarettes to Vaping Nicotine in Young Adults.

This survey study assesses trends in nicotine use among young adults in the US between 2013 and 2021.

Support for nicotine reduction in cigarettes: findings from the 2016 and 2020 ITC Four Country Smoking and Vaping Surveys.

INTRODUCTION: The USA and New Zealand have sought to establish a product standard to set a maximum nicotine level for cigarettes to reduce their addictiveness. This study examined support for very low nicotine cigarettes (VLNCs) in Australia, Canada, England and the USA between 2016 and 2020. METHODS: Repeated cross-sectional data were analysed from participants who currently smoke, formerly smoked or vaped and/or currently vape in the 2016 (n=11 150) and/or 2020 (n=5432) International Tobacco Control (ITC) Four Country Smoking and Vaping Survey. Respondents were asked if they would support a law that reduces the amount of nicotine in cigarettes to make them less addictive. Adjusted and weighted logistic regression analyses estimated the prevalence and predictors of support, such as country, age, sex, education, income, race and smoking/vaping status for VLNCs (support vs oppose/do not know). RESULTS: A majority of respondents supported a VLNC law, with support highest in Canada (69%; 2016 and 2020 combined), followed by England (61%), Australia (60%) and the USA (58%). Overall, support decreased from 62% in 2016 to 59% in 2020 (p=0.004), which did not differ by country. Levels of support differed by smoking/vaping status, where those who exclusively smoked daily showed the lowest level of support (59%) and those who exclusively vaped non-daily had the highest level of support (72%). CONCLUSION: More than half of respondents in all four countries-including those who smoked daily-supported a hypothetical VLNC standard to render cigarettes less addictive. It is important to examine if support is sustained after policies are implemented.

Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial.

Background: As summarised in the most recent Cochrane review, the few clinical trials on e-cigarettes are largely focused on smoking cessation. We aimed to determine the naturalistic uptake, use, and impact of e-cigarettes among adults who may or may not want to stop smoking. Methods: In this naturalistic, randomised, controlled clinical trial, adult smokers, across the motivational spectrum and with minimal history of e-cigarette use, were recruited online from the general community within 11 cities across the USA. Participants were randomly assigned (2:1) to either receive either a free 4-week supply of flavoured, tank-style e-cigarette, or not. E-cigarette group participants received a battery and device with up to 30 pre-filled tanks, offered among five flavours, with minimal instructions on use. The study's primary purpose was to descriptively assess naturalistic uptake and usage of the e-cigarette, and to secondarily assess its impact on smoking behavior. The latter, assessed through six months of follow-up, included: a) self-reported 7-day point prevalence abstinence, b) incidence of quit attempts, and c) smoking reduction. This trial is registered at ClinicalTrials.gov, NCT03453385. Findings: Between 5/2018 and 3/2022, 638 adult smokers were enrolled and randomly assigned (427 in the e-cigarette group and 211 in the no-product control group). Uptake of e-cigarettes was robust: approximately 70% of participants used the product, with average usage exceeding 4 days per week during the initial 30 days. Based on an intent-to-treat approach where missing data is imputed as smoking, almost all behavioral outcomes favored the e-cigarette group relative to no-product control, including point prevalence abstinence at six months (Odds Ratio [OR] = 1.8; 95% Confidence Interval [CI] = 1.0-3.1), cumulative incidence of 24-hr quit attempts (OR = 1.5; 95% CI = 1.0-2.2), and having reduced smoking by at least 50% since baseline (OR = 1.8; 95% CI = 1.2-2.7). Results were similar under an alternative imputation. Interpretation: Complementing cessation-focused trials, results suggest that unguided e-cigarette use also leads to smoking cessation, allaying the notion that causal effects of e-cigarettes on cessation are not reflective of real-world scenario of self-determined use. For smokers who may not be able to quit using existing pharmacologic approaches, e-cigarettes may be considered to achive that purpose. Funding: National Cancer Institute.

"And then I found $5": Optimizing recruitment efficiency in remote clinical trials.

Introduction: As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward. Methods: In the parent nationwide randomized clinical trial of adult smokers (N = 638), participants could enroll via mail or e-consent. Logistic regression models assessed relationships between sociodemographics and enrollment via mail (vs e-consent). Mailed consent packets were randomized (1:4) to include $5 unconditional reward or not, and logistic regression modeling examined impact of reward on subsequent enrollment, allowing for a randomized study within a study. Incremental cost-effectiveness ratio analysis estimated additional cost per additional participant enrolled with $5 incentive. Results: Older age, less education, lower income, and female sex predicted enrolling via mail vs e-consent (p < .05's). In adjusted model, older age (AOR = 1.02, p = .016) and less education (AOR = 2.23, p < .001) remained predictive of mail enrollment. The $5 incentive (vs none) increased enrollment rate by 9% (AOR = 1.64, p = .007), with estimated cost of additional $59 per additional participant enrolled. Conclusions: As e-consent methods become more common, they have potential to reach many individuals but with perhaps diminished inclusion across all sociodemographic groups. Provision of an unconditional monetary incentive is possibly a cost-effective mechanism to increase recruitment efficiency for studies employing mail-based consenting procedures.

E-Cigarette Screening in Primary Care.

INTRODUCTION: Primary care visits present an opportune time to assess behaviors that contribute to patient health. Smoking, alcohol use, and illicit drugs are routinely documented in electronic health records, but less is known about screening for E-cigarette use and the prevalence of E-cigarette use in primary care settings. METHODS: Data include 134,931 adult patients who visited 1 of 41 primary care clinics within a 12-month period (June 1, 2021-June 1, 2022). Data on demographics, combustible tobacco, alcohol, illicit drug, and E-cigarette use were extracted from electronic medical records. Logistic regression was utilized to examine the variables associated with differential odds of being screened for E-cigarette use. RESULTS: Rates of E-cigarette screening (n=46,997; 34.8%) were significantly lower than that of tobacco (n=134,196; 99.5%), alcohol (n=129,766; 96.2%), and illicit drug (n=129,766; 92.6%) use. Of those assessed for E-cigarette use, 3.6% (n=1,669) reported current use. Of those with documented nicotine use (n=7,032), 17.2% (n=1,207) used mono E-cigarettes exclusively, 76.3% (n=5,364) used combustible tobacco exclusively, and 6.6% (n=461) reported dual use (both E-cigarette use and combustible tobacco use). Those who used combustible tobacco or illicit substances as well as younger patients were more likely to have been screened for E-cigarette use. CONCLUSIONS: Overall rates of E-cigarette screening were significantly lower than those of other substances. The use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be because of the relatively recent proliferation of E-cigarettes, the recent addition of E-cigarette documentation to the electronic health record, or a lack of training on screening for E-cigarette use.

E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study.

BACKGROUND AND AIMS: Electronic nicotine delivery systems (ENDS) can help people to quit smoking combusted tobacco products (CTPs), but most current and former smokers who use ENDS also intend to quit ENDS. This analysis measured whether ENDS cessation among current and former CTP smokers is associated with changes in CTP smoking or abstinence. DESIGN: Regression analysis of a nationally representative cohort from waves 4 (W4) and 5 (W5) of the Population Assessment of Tobacco and Health Study (December 2016-November 2019). SETTING: United States. PARTICIPANTS: Adults (n = 1525) who reported W4 current or former use of ≥ 1 CTP and either currently using ENDS or quitting ENDS in the past year were included. MEASUREMENTS: Logistic regressions were performed separately among W4 current and former CTP smokers, controlling for demographic and tobacco use characteristics. First, we analyzed proximal outcomes by testing the association between ENDS quit status and CTP abstinence, both occurring during W5. Next, we analyzed long-term outcomes by testing W4 ENDS quit status as a predictor of CTP abstinence at W5, approximately 1 year later. FINDINGS: Among W4 current CTP smokers, there was no evidence that CTP smoking abstinence differed between those quitting or continuing using ENDS, both in our proximal [adjusted odds ratio (aOR) = 1.37, 95% confidence interval (CI) = 0.90, 2.10] and long-term (aOR = 0.90, 95% CI = 0.52, 1.53) analyses. Among former CTP smokers, quitting ENDS was associated with less CTP abstinence in our proximal analysis (aOR = 0.42, 95% CI = 0.20, 0.89), but there was no evidence that CTP smoking abstinence differed between those quitting or continuing using ENDS in our long-term analysis (aOR = 0.86, 95% CI = 0.44, 1.67). CONCLUSIONS: There is no evidence that ENDS cessation is associated with CTP abstinence among current smokers, although mixed findings among former smokers indicate a possible risk for relapse to smoking associated with quitting ENDS.

Is perception reality? Associations among "light" cigarettes and number of cigarettes smoked per day.

INTRODUCTION: Cigarette filter ventilation and light descriptors are associated with lowered perceptions of risk and smoking more cigarettes per day (CPD). This study examined the relationship between usual cigarette ventilation, perception, and CPD. METHODS: A crowdsourced sample (N = 995) of individuals who smoke higher-ventilated (=>20% ventilation) or lower-ventilated (=<10% ventilation) cigarettes identified their usual cigarette as "light" or "full flavor", and reported their average CPD. RESULTS: We found: 1) no association between ventilation status and perception of light versus full flavor (AUC=0.58), with the inaccurate perception being more prevalent in younger individuals (p = 0.041) and those who smoke L&M (73%, p < 0.001) and Camel (61%, p = 0.006) brands; and 2) perception, but not ventilation of usual cigarette, was significantly associated with CPD (p = 0.006), with individuals who perceived their cigarettes as light reporting an average of 13% more cigarettes per day (2.6 CPD), compared to those who perceived their cigarette as full flavor. CONCLUSIONS: Perceptions of light versus full-flavor, but not ventilation status, predicted CPD. These findings may inform anti-smoking health communication strategies and smoking cessation interventions. IMPLICATIONS: Tobacco control policies should eradicate the perception of cigarettes as light or full-flavored. Future research investigating the associations between cigarette filter ventilation and smoking behavior should consider the confounding effects that may lie in an individual's perceptions of their 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.

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 pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth.

BACKGROUND: Nicotine vaping among youth has increased, warranting concern from tobacco control proponents. Many youth who vape indicate interest in quitting; however, few empirically supported vaping cessation interventions exist. This pilot feasibility study adapted an established behavioral intervention, contingency management (CM), delivered via telehealth to promote vaping cessation among young adults. METHODS: Participants (N = 27; ages 17-21) vaping nicotine regularly were recruited via social media and digital advertisements from across the US (June 2020-January 2021). Participants were randomized at approximately 4:1 to CM or Monitoring control (22:5). CM was delivered through DynamiCare Health's smartphone app for 4 weeks, in which financial incentives were delivered contingent on abstinent cotinine samples after the quit day until the end of treatment (EOT; Days 7-28; 10 expected submissions). Control participants earned incentives for submitting cotinine, regardless of abstinence. Feasibility, acceptability, and abstinence was collected throughout treatment, at EOT, and at 1-month follow-up. RESULTS: The majority of enrolled participants completed treatment (Monitoring: 5/5; CM: 20/22), and intervention components were rated favorably overall (> 80%). CM participants submitted 112/220 (55%) abstinent cotinine samples throughout the quit attempt, while the Monitoring group submitted 4/50 (8%) negative samples. There were no differences in abstinence between groups at EOT or follow-up. CONCLUSION: This pilot study of a telehealth-based youth vaping cessation intervention demonstrated preliminary feasibility and acceptability. These results suggest that CM for young adult vaping cessation, delivered remotely, is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.

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.

Reappraising Choice in Addiction: Novel Conceptualizations and Treatments for Tobacco Use Disorder.

The introduction of alternative nicotine and tobacco products (such as e-cigarettes, heat-not-burn devices, nicotine pouches) warrants an updated framework from which to conceptualize tobacco use disorder (TUD). The following review provides considerations for TUD within the context of novel products. Historically, the tobacco industry falsely claimed that cigarettes were not addictive or harmful and that those who smoked simply chose to do so. This generated an inaccurate lay perception that smoking is a free or informed choice. Research on nicotine pharmacology demonstrates the powerful addictive potential of nicotine, which is shaped by dose, speed of delivery, and other constituents generated. In addition, non-pharmacologic reinforcers motivate and maintain tobacco use behaviors for both traditional cigarettes and novel products. The negative consequences of combustible tobacco use are well known; however, these outcomes may differ for alternative products. Strategies used for combustible product cessation may be adapted for novel products, and treatment recommendations for TUD should be made within the context of a harm reduction framework wherein alternative product use may be the desired outcome. Providers must therefore be willing to modify their perceptions of products and treatment recommendations accordingly. Better public health outcomes are accomplished through promotion of abstinence from combustible smoking. For those who cannot wean from nicotine entirely, switching to less risky modes of delivery might be a secondary goal, with an eventual aim of stopping use of the alternative product. Implications: Given the advent of novel, alternative tobacco products, tobacco use disorder (TUD) must be conceptualized within a contemporary framework that includes harm reduction and alternative outcomes. The unique contributions of nicotine pharmacology, non-pharmacologic reinforcers, and consequences of use can be used to inform treatments for TUD with the ultimate goal of improving the health of individuals who use tobacco.

Impact of nicotine reduction in cigarettes on smoking behavior and exposure: Are there differences by race/ethnicity, educational attainment, or gender?

BACKGROUND: Lowering nicotine in cigarettes may reduce smoking prevalences; however, it is not known whether an immediate or gradual reduction in nicotine is the optimal approach for all population groups. OBJECTIVES: We examined whether the optimal approach to nicotine reduction depended on the education, gender, or race of people who smoke and whether the optimal approach differentially benefited people who smoke based on their education, gender, or race. METHODS: Secondary analysis was conducted on a randomized clinical trial (N = 1250) comparing (1) immediate reduction from 15.5 to 0.4 mg of nicotine per gram of tobacco(mg/g);(2) gradual reduction to 0.4 mg/g;(3) control group with normal nicotine cigarettes(15.5 mg/g). Outcomes included cigarettes per day(CPD), carbon monoxide(CO), total nicotine equivalents(TNE), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides(NNAL), phenanthrene tetraol(PheT), N-Acetyl-S-(2-cyanoethyl)-l-cysteine(CEMA). Data were analyzed as area under the curve(AUC). RESULTS: Results were presented by education (High school[HS] or less n = 505, more than HS n = 745), gender (males n = 701, females n = 549), and race (Black participants n = 373,White participants n = 758). Regardless of education, gender, and race, CPD, CO, TNE, NNAL, PheT, and CEMA were lower in immediate versus gradual nicotine reduction. Comparing immediate versus the control, outcomes were lower for all subgroups; however, the magnitude of the effect for TNE varied by race. Specifically, geometric mean of the AUC of TNE in immediate versus gradual was 49 % lower in Black participants and 61 % lower in White participants (p-value = 0.047). CONCLUSIONS: Immediately reducing nicotine in cigarettes has the potential to benefit people who smoke across lower and higher educational attainment, male and female gender, and Black and White race.

Which tobacco control policies do smokers support? Findings from the International Tobacco Control Four Country Smoking and Vaping Survey.

As governments consider policy action to reduce smoking, a key factor in creating political will is the level of public support, particularly among smokers who are most affected by the policies. The goal of this paper is to assess and compare the level of support in Canada, the United States, England, and Australia for five smoking control policies: 1) banning menthol in cigarettes, 2) banning cigarette additives, 3) reducing nicotine in cigarettes to make them less addictive, 4) raising the minimum age to purchase cigarettes to 21 years and older, and 5) requiring pictorial warning labels on cigarette packs (examined in the US only). Data for these analyses come from 8165 daily cigarette smokers who responded to the 2016 International Tobacco Control Four Country Smoking and Vaping Survey. In all countries, the highest level of support was for raising the legal age for purchase to 21 years and older (62-70%) and reducing the nicotine content of cigarettes to make them less addictive (57-70%). Smokers who were less dependent on cigarettes and those expressing interest in quitting were more likely to support all policies. When asked how they would respond to a nicotine reduction policy, the most common response given was to try the non-nicotine cigarettes to see how they liked them (42-48%), with the next most common response being to quit smoking entirely (16-24%). The high level of support for these proposed policies among daily smokers provides important evidence for policymakers to counteract claims that such policies would be unpopular.

Exploratory evaluation of online brief education for JUUL pod-mod use and prevention.

INTRODUCTION: Initiation of e-cigarette use by young adults is a significant public health issue within the debate on vaping. The current study is an exploratory evaluation of brief educational information among young adults and investigated outcomes as a function of JUUL use and smoking status. METHODS: Participants (N = 947) were young adults (<30 years old) recruited from Amazon's Mechanical Turk based on smoking and JUUL use status. Participants completed baseline assessments, viewed a brief JUUL educational handout, and completed post-assessments. RESULTS: There was a significant Time X Group interaction for JUUL-related knowledge (p < .001), with never JUUL/never smokers showing the greatest increase in knowledge. Brief education increased JUUL-related knowledge and risk perceptions and had a modest impact on commitment to quitting and readiness to quit JUUL (all p ≤ 0.001; ds = 0.06-0.74; time × group p > .05 for all contrasts except JUUL-related knowledge). Participants showed modest decreases in interest in future JUUL use, interest in purchasing, and interest in future regular use (all p ≤ 0.001; ds = 0.07-0.08; time × group p > .05 for all contrasts). In terms of smoking outcomes, participants reported reduced perceived harm to others (p < .001; d = 0.09) and decreased intentions to smoke regularly (p = .001; d = 0.07). CONCLUSIONS: Brief education was effective in increasing knowledge and risk perceptions while showing a modest effect on intentions for future use. The information was most effective in increasing knowledge among non-users, suggesting that brief education may be useful for preventing initiation. Analysis of group differences suggest current JUUL use status is more important in informing JUUL-related attitudes than smoking status.