Switching Away From Smoking and Reduction in Cigarette Consumption among US Adult Purchasers of the JUUL System across 24 Months Including Diverse Subpopulations Disproportionately Affected by Cigarette Smoking.

OBJECTIVES: Electronic nicotine delivery systems (ENDS) can reduce tobacco-related health risks for adults who smoke cigarettes (AWS) by facilitating complete switching away from cigarettes. However, little is known about ENDS use and switching among subpopulations that have been disproportionately affected by smoking. METHODS: AWS (age≥21 years) were recruited following their first purchase of a JUUL Starter Kit in 2018. Participants self-reported switching (no past-30-day cigarette smoking) at 1-, 2-, 3-, 6-, 9-, 12-, 15-, 18-, 21-, and 24-month follow-ups. Percent switched and percent with substantial smoking reduction (≥50% decrease in cigarettes/day among those who continued smoking) were calculated. Analyses focused on racial/ethnic minorities, persons with low income and education levels, sexual minorities, and those with mental and physical health conditions. RESULTS: Overall rates of switching away from cigarettes increased across follow-ups to 51.2% (Month-12) to 58.6% (Month-24, 87% of whom used ENDS). Among those who continued to smoke at 24 months, 45.4% reduced cigarettes/day by ≥50%. Rates of switching and substantial smoking reduction were largely similar across subgroups, with some statistically significant, but small, differences in Month-24 switching rates(e.g. education, mental/physical health conditions; switch rate range: 42~57%). CONCLUSIONS: AWS demonstrated progressively increasing switching rates over two years after purchasing JUUL products. Similar trends in switching and smoking reduction were observed across populations disproportionately affected by smoking. By facilitating switching and smoking reduction, ENDS products such as JUUL may provide an opportunity to reduce smoking-related harm among some populations disproportionately affected by smoking, potentially reducing tobacco-related health disparities. IMPLICATIONS: ENDS have the potential to benefit population health if they can replace cigarettes. This benefit must extend to populations disproportionately affected by smoking. In this real-world study, 59% of JUUL purchasers reported complete switching two years later (no past-30-day smoking, with most continuing to use ENDS). Further, 45% of those who continued to smoke reduced cigarette consumption by at least half. These rates of switching and smoking reduction were largely comparable across populations disproportionately affected by smoking (defined, e.g., by ethnicity and income). ENDS can serve as an effective harm reduction strategy to complement current efforts to reduce tobacco-related disparities.

Comparing Adult Smokers Who Switched to JUUL versus Continuing Smokers: Biomarkers of Exposure and of Potential Harm and Respiratory Symptoms.

OBJECTIVES: Real-world evidence on exposure to harmful and potentially harmful constituents (HPHCs) and on biological effects in cigarette smokers who switch to electronic nicotine delivery systems (ENDS) can inform the health effects of switching. AIMS AND METHODS: This cross-sectional, observational study assessed adults who had smoked ≥10 cigarettes/day for ≥10 years, comparing 124 continuing cigarette smokers (Smokers) to 140 former smokers who switched to JUUL-brand ENDS exclusively for ≥6 months (Switchers). Assessments included biomarkers of exposure (BOEs) to select HPHCs, biomarkers of potential harm (BOPHs) related to smoking-related diseases, psychometric assessments of dependence on cigarettes and ENDS, respectively, and respiratory symptoms. Planned analyses compared geometric means, adjusted for demographic covariates; further analyses adjusted for additional lifestyle and smoking history covariates. RESULTS: Nicotine levels were significantly higher in Switchers (median time switched = 3 years), who were unusually heavy users of JUUL. All other BOEs, including NNAL and HPMA3 (primary endpoints), were significantly lower in Switchers than Smokers. Most BOPHs (sICAM-1 [primary], and eg, white blood cell count, MCP1, HbA1c) were significantly lower in Switchers than Smokers; HDL was significantly higher. Switchers reported significantly lower dependence on JUUL than Smokers did on cigarettes, and respiratory symptom scores were significantly lower among Switchers than Smokers. CONCLUSIONS: Compared to continuing smokers, smokers who switched to JUUL had substantially lower exposures to multiple HPHCs, favorable differences in markers of inflammation, endothelial function, oxidative stress, and cardiovascular risk, and fewer respiratory symptoms. These findings suggest that switching from cigarettes to JUUL likely reduces smokers' health risks. IMPLICATIONS: Short-term confinement studies and randomized clinical trials demonstrate that adult smokers who switch completely to ENDS experience substantial reductions in exposure to many smoking-related toxicants. This study extends those findings to longer periods of switching to JUUL-brand ENDS (almost 3 years on average) under naturalistic use conditions in real-world settings and also found that switching to JUUL resulted in favorable differences in BOPHs more proximally related to smoking-induced disease, as well as in respiratory symptoms. Smokers who switch to ENDS reduce their exposure to toxicants, likely reducing their disease risk.

Adult smokers' Complete Switching Away from Cigarettes at 6, 9, and 12 Months after Initially Purchasing a JUUL e-Cigarette.

Background: Electronic nicotine delivery systems (ENDS) have the potential to benefit public health if smokers completely switch from cigarettes to ENDS. Methods: A cohort of adult smokers (age ≥ 21) who purchased a JUUL Starter Kit was followed for 12 months after the initial purchase. We defined "switching" as past-30-day abstinence from smoking (even if JUUL use had stopped), and analyzed factors associated with achievement and maintenance of self-reported repeated point-prevalence switching (RPPS) at three follow-ups, i.e., no past-30-day smoking at months 6, 9, and 12. Results: RPPS was reported by 21.6% of the 12,537 evaluable smokers. Smokers with lighter smoking history and lower cigarette dependence at baseline were more likely to report RPPS. RPPS was also associated with daily use of JUUL (Month-3: OR = 2.32, 95% CI = 2.02-2.68; Month-6: OR = 1.73, 95% CI = 1.42-2.10), and with greater subjective reinforcing effects from JUUL use (assessed by the mCEQ, Month-3: OR = 1.46, 95% CI = 1.38-1.56; Month-6: OR = 1.11; 95% CI = 1.02-1.20). Even among smokers who did not meet the criteria of RPPS (i.e., who smoked at least once), 35.5% reported past 30-day point-prevalence switching on at least one follow-up, and their cigarette consumption was substantially reduced compared to baseline. Conclusions: Approximately one-fifth of adult smokers reported 30-day point-prevalence abstinence at 6, 9, and 12 months after purchasing JUUL. Greater use of JUUL and stronger subjective reinforcing effects were associated with nonsmoking, validating the potential for ENDS to substitute for smoking, with potential for positive impacts on individual and population health.

Reply to Commentary on "Adult Smokers' Complete Switching Away from Cigarettes at 6, 9, and 12 Months After Initially Purchasing a JUUL e-Cigarette" and the Adult JUUL Switching and Smoking Trajectories (ADJUSST) Study.

BACKGROUND: This is authors' reply to the Commentary on our publication entitled "Adult smokers' Complete Switching Away from Cigarettes at 6, 9, and 12 Months after Initially Purchasing a JUUL e-Cigarette." METHODS AND RESULTS: Analyses addressed questions about follow-up rates and missed responses in the Adult JUUL Switching and Smoking Trajectories (ADJUSST) Study. Results demonstrate limited potential for selection bias, as participants who missed surveys were similar to those with complete data, and re-contact of participants who missed a follow-up indicated almost half were not smoking. Imputing smoking behavior for missing data would likely introduce bias and is not appropriate. The study demonstrated that JUUL products can facilitate high rates of complete switching away from cigarettes as suggested in previous experimental and observational studies. The ADJUSST cohort, including baseline nonsmokers, demonstrates a net reduction in smoking prevalence. Moreover, population modeling considering both benefits and harms demonstrated a net population benefit. CONCLUSION: While the ADJUSST Study is not without limitations, the findings are consistent with multiple streams of real-world evidence that indicate that ENDS can facilitate switching among adults who smoke, and provide population benefits.

What Substances Are Adolescents Vaping? Estimating Nicotine-Specific and Cannabis-Specific Vaping from US National Youth Surveys.

BACKGROUND: Youth use of electronic cigarettes ("e-cigarettes") is an ongoing concern. Vaping is usually assumed to be of nicotine, but survey responses may also include vaping of non-nicotine substances (particularly cannabis), which can impose different risks. The current study quantifies the proportions of nicotine-specific and cannabis-specific vaping among adolescents. METHODS: Data from the Monitoring the Future (MTF) 2021 survey were analyzed with respect to the substance vaped: nicotine, cannabis, or flavoring only. Past-30-day (P30D) nicotine-specific vaping (exclusively, or also having vaped other substances) and cannabis-specific vaping were calculated. Results were also broken down by grade level, cigarette smoking history (current, former, or never), and frequency of e-cigarette use (<20 vs. 20+ days in P30D). RESULTS: Among 4706 P30D e-cigarette users, 84.2% vaped nicotine; the remaining 15.8% reported not vaping any nicotine in P30D. Cannabis vaping was reported by 48.4% of P30D vapers. Vaping both nicotine and cannabis in P30D was more common in current and former smokers than in never-smokers, and in frequent vapers (of any substance). Conversely, never-smokers were more commonly vaping cannabis but not nicotine, compared to current and former smokers. Supplementary NYTS 2022 analyses were consistent with these findings. CONCLUSIONS: A notable proportion of self-reported P30D vapers reported not vaping nicotine; nearly half vaped cannabis. Capturing the variety of substances used in vaping devices is imperative for accurate public health surveillance of both nicotine and cannabis vaping among US adolescents, considering their different respective harms and regulatory frameworks.

Examining reactivity to intensive longitudinal ecological momentary assessment: 12-month prospective study.

PURPOSE: To examine the association between intensive, longitudinal ecological momentary assessment (EMA) and self-reported eating behaviors. METHODS: Secondary analysis of the EMPOWER study-a 12-month observational study that examined the microprocesses of relapse following intentional weight loss using smartphone-administered EMA-was conducted. Participants were asked to complete four types of EMA surveys using a mobile app. For this analysis, only the number of completed random EMA surveys was used. Using linear mixed-effects modeling, we analyzed whether the number of completed random EMA surveys was associated with changes in self-reported dietary restraint, dietary disinhibition, and susceptibility to hunger measured using the Three-Factor Eating Questionnaire (TFEQ). RESULTS: During the 12-month study, 132 participants completed a mean of 1062 random EMA surveys (range: 673-1362). The median time it took for participants to complete random EMA surveys was 20 s and 90% of random EMA surveys were completed within 46 s. The number of completed random EMA surveys was not significantly associated with the TFEQ scores. CONCLUSIONS: Intensive longitudinal EMA did not influence self-reported eating behaviors. The findings suggest that EMA can be used to frequently assess real-world eating behaviors with minimal concern about assessment reactivity. Nonetheless, care must be taken when designing EMA surveys-particularly when using self-reported outcome measures. LEVEL OF EVIDENCE: Level III, prospective observational study.

Population-level counterfactual trend modelling to examine the relationship between smoking prevalence and e-cigarette use among US adults.

BACKGROUND: Studies have suggested that some US adult smokers are switching away from smoking to e-cigarette use. Nationally representative data may reflect such changes in smoking by assessing trends in cigarette and e-cigarette prevalence. The objective of this study is to assess whether and how much smoking prevalence differs from expectations since the introduction of e-cigarettes. METHODS: Annual estimates of smoking and e-cigarette use in US adults varying in age, race/ethnicity, and sex were derived from the National Health Interview Survey. Regression models were fitted to smoking prevalence trends before e-cigarettes became widely available (1999-2009) and trends were extrapolated to 2019 (counterfactual model). Smoking prevalence discrepancies, defined as the difference between projected and actual smoking prevalence from 2010 to 2019, were calculated, to evaluate whether actual smoking prevalence differed from those expected from counterfactual projections. The correlation between smoking discrepancies and e-cigarette use prevalence was investigated. RESULTS: Actual overall smoking prevalence from 2010 to 2019 was significantly lower than counterfactual predictions. The discrepancy was significantly larger as e-cigarette use prevalence increased. In subgroup analyses, discrepancies in smoking prevalence were more pronounced for cohorts with greater e-cigarette use prevalence, namely adults ages 18-34, adult males, and non-Hispanic White adults. CONCLUSION: Population-level data suggest that smoking prevalence has dropped faster than expected, in ways correlated with increased e-cigarette use. This population movement has potential public health implications.

US adult smokers' perceived relative risk on ENDS and its effects on their transitions between cigarettes and ENDS.

BACKGROUND: Perceived risk reduction motivates smokers to switch to electronic nicotine delivery systems (ENDS). This research examines US smokers' relative risk perceptions and their prospective association with various behavioral stages of switching to ENDS. METHODS: Data from the nationally representative, longitudinal Population Assessment of Tobacco and Health (PATH) Adult survey, Waves 1 (2014) through 5 (2019), were analyzed. We assessed the association between the perceived risk of ENDS relative to cigarettes ("less harmful" vs. "equally harmful" or "more harmful") and 1) adoption of ENDS (among never-ENDS-using smokers), 2) complete switching to ENDS (i.e., stopping smoking, among ever-ENDS-using smokers), and 3) avoiding reversion to smoking (among smokers who had switched to ENDS), at the next wave. RESULTS: The proportion of US smokers perceiving ENDS as less harmful than cigarettes continually decreased, reaching 17.4% in Wave 5 (2019). Current smokers with such belief were more likely to adopt ENDS (aOR 1.31; 95% CI 1.15-1.50) and switch completely to ENDS (aOR 2.24; 95% CI 1.89-2.65) in the subsequent wave. Among smokers who had switched within the past year, such beliefs predicted avoidance of resumption of smoking in the next wave (aOR 0.55; 95% CI 0.33-0.93). CONCLUSIONS: Smokers' beliefs about the relative risk of ENDS compared to cigarettes had a strong and consistent association with transitions between smoking and ENDS use. Addressing the growing misperception about ENDS has the potential to contribute to public health by encouraging smokers' switching to ENDS.

Nightly Variation in Sleep Influences Self-efficacy for Adhering to a Healthy Lifestyle: A Prospective Study.

BACKGROUND: Self-efficacy, or the perceived capability to engage in a behavior, has been shown to play an important role in adhering to weight loss treatment. Given that adherence is extremely important for successful weight loss outcomes and that sleep and self-efficacy are modifiable factors in this relationship, we examined the association between sleep and self-efficacy for adhering to the daily plan. Investigators examined whether various dimensions of sleep were associated with self-efficacy for adhering to the daily recommended lifestyle plan among participants (N = 150) in a 12-month weight loss study. METHOD: This study was a secondary analysis of data from a 12-month prospective observational study that included a standard behavioral weight loss intervention. Daily assessments at the beginning of day (BOD) of self-efficacy and the previous night's sleep were collected in real-time using ecological momentary assessment. RESULTS: The analysis included 44,613 BOD assessments. On average, participants reported sleeping for 6.93 ± 1.28 h, reported 1.56 ± 3.54 awakenings, and gave low ratings for trouble sleeping (3.11 ± 2.58; 0: no trouble; 10: a lot of trouble) and mid-high ratings for sleep quality (6.45 ± 2.09; 0: poor; 10: excellent). Participants woke up feeling tired 41.7% of the time. Using linear mixed effects modeling, a better rating in each sleep dimension was associated with higher self-efficacy the following day (all p values < .001). CONCLUSION: Our findings supported the hypothesis that better sleep would be associated with higher levels of reported self-efficacy for adhering to the healthy lifestyle plan.

The Ethics of Tobacco Harm Reduction: An Analysis of E-Cigarette Availability From the Perspectives of Utilitarianism, Bioethics, and Public Health Ethics.

Much evidence suggests e-cigarettes are substantially less harmful than combustible cigarettes. Assuming this is true, we analyze the ethical case for a policy of e-cigarette availability (ECA) as a tobacco harm reduction strategy. ECA involves making e-cigarettes available to allow smokers to switch to them, and informing smokers of the lower risks of e-cigarettes vis-à-vis smoking. After suggesting that utilitarian/consequentialist considerations do not provide an adequate ethical analysis, we analyze ECA using two other ethical frameworks. First, ECA is supported by a public health ethics framework. ECA is a population-level intervention consistent with respecting individual autonomy by using the least restrictive means to accomplish public health goals, and it supports equity and justice. Second, ECA is supported by four principles that form a biomedical ethics framework. By reducing smokers' health risks and not harming them, ECA fulfills principles of beneficence and non-maleficence. Because ECA allows smokers to make informed health decisions for themselves, it fulfills the principle requiring respect for persons and their autonomy. Here, we consider whether nicotine addiction and thus ECA undermine autonomy, and also discuss the ethical warrant for special protections for youth. Finally, ECA can also advance justice by providing a harm reduction alternative for disadvantaged groups that disproportionately bear the devastating consequences of smoking. Policies of differential taxation of cigarettes and e-cigarettes can facilitate adoption of less harmful alternatives by those economically disadvantaged. We conclude that public health and biomedical ethics frameworks are mutually reinforcing and supportive of ECA as a tobacco harm reduction strategy. Implications: Making e-cigarettes and information about them available is supported as ethical from multiple ethical perspectives.

Changes in Biomarkers of Cigarette Smoke Exposure After 6 Days of Switching Exclusively or Partially to Use of the JUUL System with Two Nicotine Concentrations: A Randomized Controlled Confinement Study in Adult Smokers.

INTRODUCTION: Evidence suggests that cigarette smokers who switch to electronic nicotine delivery systems (ENDS) reduce their exposure to harmful toxicants and carcinogens. It is unclear if dual-use is associated with decreases in exposure to toxicants. METHODS: This parallel-group confinement study assessed changes in biomarkers of exposure (BOEs) over six days among healthy adult smokers who were randomized into 1 of 11 study groups: eight JUUL-brand System (JUUL) groups (4 JUUL flavors [Virginia Tobacco, Menthol, Mint, Mango] × 2 nicotine concentrations [5.0% or 3.0% by weight]); Dual-Use group used preferred JUUL flavor (5.0% nicotine) and ≤50% usual brand (UB) cigarettes/day; UB Cigarette group and one group abstained from all tobacco/nicotine product use (Abstinence group). Urine and blood analysis assessed changes in primary BOE endpoints (NNAL, 3-HPMA, MHBMA, S-PMA COHb) and secondary BOE endpoints (NNN, HMPMA, CEMA, 1-OHP, O-toluidine, 2-NA, 4-ABP) among 279 adult smokers. RESULTS: In JUUL groups, median percent reductions in primary BOEs (Day 6-Baseline) were 90%-≥100% of Abstinence; there were no significant differences between JUUL groups and Abstinence. All reductions in JUUL groups were substantially and statistically significantly greater than reductions in the UB Cigarette group (ps < 0.025). Median reductions in primary BOEs in the Dual-Use group were 43%-55% of Abstinence. Similar results were observed for secondary BOEs. CONCLUSION: This study suggests that the use of JUUL as a complete or partial substitute (i.e., dual-use with ≥50% reduction in cigarette consumption) for combustible cigarettes can substantially reduce exposure to multiple toxins associated with cigarette smoking. IMPLICATIONS: This study adds to the growing body of evidence supporting the utility of ENDS products as potentially reduced-harm alternatives to cigarettes for adult smokers. Adult smokers who switched completely from cigarette smoking to use of the JUUL System ("JUUL") in two nicotine concentrations (5.0% and 3.0%) and four flavors significantly reduced their exposure to multiple classes of cigarette-related toxicants. Additionally, smokers who used JUUL and continued smoking but reduced their daily cigarette consumption by ≥50% (dual users) also significantly reduced their toxicant exposure compared to cigarette smoking.

Differences in Switching Away From Smoking Among Adult Smokers Using JUUL Products in Regions With Different Maximum Nicotine Concentrations: North America and the United Kingdom.

INTRODUCTION: Electronic nicotine delivery systems (ENDS) may improve public health if they facilitate smokers switching away from cigarettes. Conceptually, switching is facilitated when ENDS provide adequate nicotine delivery. Switching rates among smokers who purchased the JUUL System ("JUUL") were compared in the United Kingdom (UK), where regulations limit nicotine concentration to 20 mg/mL versus North America (N.Am.; United States and Canada), where higher concentrations are available. AIMS AND METHODS: Adult established smokers (age ≥21, smoked ≥100 cigarettes, smoking some days or every day at baseline) who newly purchased JUUL were recruited into a longitudinal study (UK: N = 1247; N.Am.: N = 8835). Complete switching (no smoking for ≥30 days) was assessed 1, 3, and 6 months after purchase; propensity score matching (PSM) and logistic regression compared switching after adjusting for baseline characteristics. RESULTS: In both N.Am. and UK, ≥82% of participants reported using the highest JUUL nicotine concentration available (UK: 18 mg/mL; N.Am.: 59 mg/mL). Unadjusted switching rates did not differ at 1 month (17%-18%); unadjusted and adjusted rates were significantly higher in N.Am. (vs. UK) at 3 and 6 months. In the PSM sample, after additional covariate adjustment, rates were significantly higher in N.Am. (vs. UK) at 3 months (31.5% vs. 22.7%; odds ratio [95% confidence interval, CI] = 1.59 [1.25, 2.02]) and 6 months (38.0% vs. 26.0%; odds ratio [95% CI] = 1.79 [1.37, 2.35]). CONCLUSIONS: These results suggest availability of ENDS in nicotine concentrations greater than 20 mg/mL may be associated with increased switching among adult smokers. Differences in smoking and ENDS use characteristics did not explain associations of location and switching; however, between-country differences may be affected by unmeasured factors. IMPLICATIONS: Switching rates were lower among smokers who purchased the JUUL System ("JUUL") in the UK, where regulations limit nicotine concentration to 20 mg/mL versus N.Am. (United States and Canada), where higher concentrations are available-before and after controlling for differences in smoking and ENDS use characteristics. These results suggest availability of ENDS in nicotine concentrations greater than 20 mg/mL may be associated with increased switching among adult smokers. Between-country differences may be affected by unmeasured factors; future research should consider these factors and the extent to which regulatory policy environments may explain differences in switching among adult smokers.

Using Nicotine Gum to Assist Nondaily Smokers in Quitting: A Randomized Clinical Trial.

INTRODUCTION: Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit. METHODS: ITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects. RESULTS: Nicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time. CONCLUSIONS: Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence. IMPLICATIONS: Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.

Five-year trends in acetaminophen use exceeding the recommended daily maximum dose.

Temporal patterns of acetaminophen use exceeding the recommended daily maximum dosage of 4 g over a 5-year period (4/1/2011-3/31/2016) were evaluated in an online 1-week diary study of 14 434 adult acetaminophen users who also reported acetaminophen use in the previous month. Specific medications taken were identified by list-based prompting; respondents were not required to know their medications contained acetaminophen. Details of use were recorded daily; total daily dosage was determined programmatically. Prevalence of >4 g use over time was modelled and tested for linear changes. The overall prevalence of >4 g use (6.3% of users and 3.7% of usage days) did not change over the 5 years: odds ratio (OR) persons, 1.02 (95% CI, 0.98-1.09); OR days, 0.98 (0.92-1.05). Deviations from label directions were largely unchanged, though concomitant use increased slightly. Thus, over a recent 5-year period, there was no evidence of change in how often acetaminophen use exceeded the labelled maximum daily dose.

Randomized Trial to Compare Smoking Cessation Rates of Snus, With and Without Smokeless Tobacco Health-Related Information, and a Nicotine Lozenge.

Introduction: Nicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information). Methods: A randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days). Results: Abstinence rates did not differ significantly between snus and the nicotine lozenge-continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups. Conclusions: Smoking cessation rates were comparable between snus and a nicotine lozenge, but success rates in this trial were low. Implications: This randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.

Daily stress as link between disadvantage and smoking: an ecological momentary assessment study.

BACKGROUND: There is a well-established social gradient in smoking, but little is known about the underlying behavioral mechanisms. Here, we take a social-ecological perspective by examining daily stress experience as a process linking social disadvantage to smoking behavior. METHOD: A sample of 194 daily smokers, who were not attempting to quit, recorded their smoking and information about situational and contextual factors for three weeks using an electronic diary. We tested whether socioeconomic disadvantage (indicated by educational attainment, income and race) exerts indirect effects on smoking (cigarettes per day) via daily stress. Stress experience was assessed at the end of each day using Ecological Momentary Assessment methods. Data were analyzed using random effects regression with a lower-level (2-1-1) mediation model. RESULTS: On the within-person level lower educated and African American smokers reported significantly more daily stress across the monitoring period, which in turn was associated with more smoking. This resulted in a small significant indirect effect of daily stress experience on social disadvantage and smoking when using education and race as indicator for social disadvantage. No such effects were found when for income as indicator for social disadvantage. CONCLUSION: These findings highlight the potential for future studies investigating behavioral mechanisms underlying smoking disparities. Such information would aid in the development and improvement of interventions to reduce social inequality in smoking rates and smoking rates in general.

A latent state-trait model for analyzing states, traits, situations, method effects, and their interactions.

OBJECTIVE: Studies on situation and Person × Situation interaction effects often use only one method of measurement, so that the extent to which the effects may be method-specific cannot be determined. We introduce a new multimethod latent state-trait model for random and fixed situations (MM-LST-RF), which allows examining person, situation, and Person × Situation interaction effects in the context of multimethod measurement designs (e.g., studies with multiple reporters), and discuss potential areas of application for the new model in personality research. METHOD: The new model allows analyzing novel features of multimethod, multi-situation data, including (a) the convergent validity and method specificity of trait (person) effects, situation effects, and Person × Situation interaction effects; (b) the degree of situation specificity of method effects; and (c) potential Method × Situation interactions. An application to smoker's affect (N = 235; 57% female; 93% Caucasian) before and after quitting smoking is presented with positively and negatively worded items as methods. RESULTS: The MM-LST-RF model fit the smoking data well. Method specificity of many effects was high. CONCLUSIONS: The MM-LST-RF model provides researchers with a new framework for testing method specificity of person, situation, and interaction effects.

Prevalence of exceeding maximum daily dose of paracetamol, and seasonal variations in cold-flu season.

AIMS: To estimate prevalence of excess intake of paracetamol and investigate seasonal variations therein. METHODS: Between 2011 and 2016, 14 481 US adults who used paracetamol in the preceding 30 days were sampled from national online panels and completed a detailed online daily diary of paracetamol medication use for 7 days. Respondents were not told that the study concerned paracetamol. Cold/flu season (CFS), identified using Google Trends data, was contrasted to off-season in symptoms, use of paracetamol medications, and consumption exceeding 4 g (the recommended daily maximum). RESULTS: Overall, 6.3% [95% confidence interval: 5.9-6.7%] of users exceeded 4 g on at least one day; 3.7% [3.5-3.8%] of usage days exceeded 4 g. Cold/flu symptoms were more likely to be experienced and treated with paracetamol in CFS than off-season. Paracetamol users were more likely to exceed 4 g during CFS (6.5% vs. 5.3%; odds ratio = 1.24, 1.04-1.48); days exceeding 4 g also increased (3.9% vs. 2.8%; odds ratio = 1.37, 1.11-1.69). This was not due to differences in characteristics of individuals using paracetamol in CFS, but primarily to increased use of over-the-counter combination medications designed to treat upper respiratory cold/flu symptoms (33.2% of usage days in CFS vs. 24.8% in off-season; odds ratio = 1.58, 1.46-1.72). When such medications were omitted, there was no statistically significant seasonal variation in exceeding 4 g. CONCLUSIONS: Paracetamol use and over-dosing increases in CFS, primarily due to increased use of over-the-counter combinations treating upper respiratory cold/flu symptoms. Pharmacists should warn users to follow labelled dosing directions, especially during CFS.

Increases in Cigarette Consumption and Decreases in Smoking Intensity When Nondaily Smokers Are Provided With Free Cigarettes.

Introduction: Studies testing novel tobacco products often provide participants with free product and assess consumption. Some, but not all, studies find that providing free cigarettes increases smoking. We tested changes in smoking when free cigarettes were provided to nondaily, intermittent smokers, who constitute one-third of US adult smokers. Methods: Cigarette consumption was assessed by Time-Line Follow-Back in 235 intermittent smokers for two 2-week periods: when providing their own cigarettes and when provided own-brand cigarettes for free. Smoking topography and carbon monoxide boost were assessed for one cigarette at the end of each period. Results: Cigarette consumption increased significantly, by 66% (from 1.98 to 3.28 cigarettes per day), when cigarettes were available for free; both the number of days the subjects smoked and the number of cigarettes on those days increased. The increases were significantly greater among African Americans, those Fagerström Tobacco Nicotine Dependence scores >0, those with incomes less than US $25,000 per year, those who engaged in greater conscious restraint of smoking, and for smokers of menthol cigarettes, or "longs." Smoking intensity (smoke volume, by topography) and carbon monoxide boost decreased significantly when cigarettes were provided for free. Conclusions: Providing intermittent smokers with free cigarettes substantially increased their smoking while decreasing smoking intensity. The increases in smoking varied according to multiple individual and cigarette-type differences. These phenomena may complicate interpretation of studies that compare consumption of a free test product with cigarette consumption or constituent exposure when smokers are providing their own cigarettes. They also suggest that cigarette cost and variations in low-level dependence and in smoking restraint are factors in nondaily smoking. Implications: The study shows that providing nondaily smokers with free cigarettes increases cigarette consumption, but does differentially for different subgroups and cigarette types, while also decreasing smoking intensity. This suggests the value of using free-cigarette baseline data in studies where interventions provide free cigarettes.

Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users.

PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective and very commonly used, but also have side effects. We determined prevalence of NSAID dosing exceeding the daily limit (EDL) and identified related user characteristics and dosing patterns among current ibuprofen users. METHODS: Online 1-week diary study of 1326 ibuprofen users. NSAIDs were identified by list-based prompting; respondents were not required to know their medications were NSAIDs. Details of hourly use were recorded by respondents daily. Deviations from dosing directions were programmatically determined afterwards. An exit survey obtained information on demographics, medical history, physical and mental health status, attitudes regarding label reading and dosing behavior, and knowledge of product label instructions. RESULTS: Most diary users (90%) took over-the-counter ibuprofen during the week; 37% also took non-ibuprofen NSAIDs. Most did not recognize all products taken as NSAIDs. EDL occurred among 11% of users for ibuprofen, 4% of users for other NSAIDs, and on 9.1% of NSAID usage days. EDL was associated with deviations from detailed dosing directions, particularly exceeding the 1-time dose, which occurred more often with medications with 1-pill doses. Personal characteristics associated with EDL included male sex, ongoing pain, poor physical function, daily smoking, having the attitudes of "choosing my own dose" and not starting with the lowest dose, and poor knowledge of the recommended 1-time and 24-hour doses. CONCLUSIONS: The prevalence of EDL among NSAID users is nontrivial, and it is associated with potentially modifiable factors. Educating consumers about NSAIDs and their dosing directions could reduce excess dosing.