Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction.

BACKGROUND: Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period. METHODS: Participants (N = 520) who smoked ≥10 cigarettes per day [CPD] for ≥1 year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions: an ENDS containing 0, 8, or 36 mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05. RESULTS: Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (<$10 K) were more likely to be withdrawn compared to those earning $10 K-39 K, and those with the highest income ($100 K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99 K. CONCLUSION: ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts is needed for specific subgroups. Trial Registration #: NCT02342795.

YOUNG USERS OF ELECTRONIC CIGARETTES EXHIBIT REDUCED CARDIORESPIRATORY FITNESS.

BACKGROUND: Electronic nicotine delivery systems, often referred to as e-cigarettes, are popular tobacco products frequently advertised as safer alternatives to traditional cigarettes despite preliminary data suggesting a potential negative cardiovascular impact. Cardiorespiratory fitness is a critical cardiovascular health marker that is diminished in individuals who consume traditional tobacco products. Whether the use of e-cigarettes impacts cardiorespiratory fitness is currently unknown. Thus, the purpose of this study was to investigate the impact of regular e-cigarette use on cardiorespiratory fitness in young healthy adults. METHODS: Twenty-six users of e-cigarettes (ECU, 13 males, and 13 females; age: 24±3 yr; e-cigarette usage 4±2 yr.) and sixteen demographically matched non-users (NU, 6 males, and 10 females; age: 23±3 yr.) participated in this study. Cardiorespiratory fitness was measured by peak oxygen consumption (VO2peak) during a cardiopulmonary exercise test. Measurements of chronotropic response, hemodynamic, oxygen extraction and utilization were also evaluated. RESULTS: Our results suggest that regular users of e-cigarettes exhibited significantly lower peak oxygen consumption when compared to non-users, even when controlled by fat-free mass and lean body mass. Hemodynamic changes were not different between both groups during exercise, while lower chronotropic responses and skeletal muscle oxygen utilization were observed in users of e-cigarettes. CONCLUSIONS: Results from the present study demonstrate that young, apparently healthy, regular users of e-cigarettes exhibit significantly reduced cardiorespiratory fitness, lower chronotropic response, and impaired skeletal muscle oxygen utilization during exercise. Overall, our findings contribute to the growing body of evidence that supports adverse effects of regular e-cigarette use on cardiovascular health.

A Multi-Year Characterization of Confiscated Vaping Products from Virginia School Youth.

The United States (US) Food and Drug Administration's (FDA) regulatory oversight over electronic cigarettes (e-cigs) includes access restriction for persons <21 years of age and flavor restrictions for "cartridge-based" products. Despite the restrictions, consumption by US youth perseveres. Studies on youth e-cig use are limited by the reliability and accuracy of self-reports. As an alternative to self-reports, the current study examined nicotine, cannabinoid, and unlabeled e-cigs and other vaping products confiscated from Virginia public schools to characterize trends among students. Findings highlight a shift from JUUL and pod-based products to single use disposable e-cigs following the FDA flavor restrictions on cartridge-based e-cigs. Chemical analysis of e-liquids by gas chromatography-mass spectrometry identified a wide variety of flavorants and an increase in the prevalence of synthetic coolants. Most confiscated products were nicotine salt formulations, but the prevalence of cannabinoid-based vaping products increased. The popularity of flavored disposable e-cigs highlights the need for further restrictions to reduce youth consumption. The increasing use of synthetic coolants instead of menthol may suggest that manufacturers are employing tactics to bypass regulations. Continued youth access to e-cigs and the abundance of cannabinoid-based products is problematic from health and safety perspectives. Continued research incorporating confiscated product analysis can be used to understand youth access to vaping products and evolutions in manufacturing practices.

Impact of Smoking Cessation Motivations and Barriers on Quit Intentions Following a Hypothetical Flavor Ban Among African American/Black Individuals Who Use Menthol Cigarettes: A Mixed-Methods Study.

INTRODUCTION: The Food and Drug Administration (FDA) has proposed banning cigarettes and cigars with characterizing flavors-products used disproportionately by African American/black (AA/B) individuals. Little is known about how AA/B individuals who smoke menthol cigarettes will respond to flavor bans or how to amplify the intended benefits. This study explored predictors of quit intentions following a hypothetical flavor ban and further probed anticipated ban-related responses. AIMS AND METHODS: We recruited 213 AA/B individuals who use menthol cigarettes from Richmond, VA (September 2021-August 2022) for a mixed-methods study. Participants rated seven motivations for quitting and six barriers to quitting (Not a motivation or challenge[1]-Major motivation or challenge[4]), then reported how likely they were to quit smoking if characterizing flavors were banned in cigarettes and cigars. A subsample of 31 participants completed semi-structured interviews to further explore reactions to flavor restriction policies. RESULTS: Multivariable linear regressions suggested that participants who were more motivated to quit smoking because of "information about health hazards" and the "cost of cigarettes" reported higher quit intentions following a hypothetical menthol ban (p < .05). Additionally, those with cessation-related weight concerns reported lower post-ban quit intentions (p < .05). Interview themes highlighted smoking for stress reduction, harm/addiction perceptions of flavored tobacco products, trusted sources of tobacco-related information (including testimonials from people who formerly smoked), potential ban responses, and varying experiences with cessation strategies. CONCLUSIONS: Culturally specific cessation strategies that emphasize the health-related benefits of quitting, particularly those featuring the experiences of people who formerly smoked, may help AA/B individuals who smoke menthol cigarettes quit following a menthol ban. IMPLICATIONS: For the FDA's proposed bans on characterizing flavors in cigarettes and cigars to advance racial health equity, they must maximize cessation among African American/black (AA/B) individuals who use menthol cigarettes. This work suggests information on the health hazards and costs of smoking, as well as concerns over gaining weight, were predictors of quit intentions in a hypothetical flavor ban. Qualitative data suggest messaging highlighting the experiences of individuals who successfully quit may constitute an effective communication strategy. These insights can be used in the development of culturally specific cessation strategies for AA/B individuals who smoke menthol cigarettes.

Effects of liquid nicotine concentration and flavour on the acceptability of electronic nicotine delivery systems (ENDS) among people who smoke participating in a randomised controlled trial to reduce cigarette consumption.

BACKGROUND: Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking. METHODS: People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction. RESULTS: Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups. CONCLUSIONS: Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

Evidence of premature vascular dysfunction in young adults who regularly use e-cigarettes and the impact of usage length.

BACKGROUND: Electronic (e-) cigarettes are increasingly popular tobacco products on the US market. Traditional tobacco products are known to cause vascular dysfunction, one of the earliest indicators of cardiovascular disease (CVD) development. However, little is known about the effect of regular e-cigarette use on vascular function. The purpose of this study was to investigate the impact of regular e-cigarette use on vascular function and cardiovascular health in young, healthy adults. METHODS: Twenty-one regular users of e-cigarettes (ECU) and twenty-one demographically matched non-users (NU) completed this study. Vascular health was assessed in the cutaneous microcirculation through different reactivity tests to evaluate overall functionality, endothelium-dependent vasodilation (EDD), and endothelium-independent vasodilation (EID). Macrovascular function was assessed using flow-mediated dilation (FMD). RESULTS: Our results suggest that regular users of e-cigarettes present with premature microvascular impairment when compared to non-users. Specifically, they exhibit lower hyperemic (p = 0.003), thermal (p = 0.010), and EDD (p = 0.004) responses. No differences in EID between the groups were identified. We also identified that individuals who use e-cigarettes for longer than 3 years also present with systemic manifestations, as observed by significantly reduced macrovascular (p = 0.002) and microvascular (p ≤ 0.044) function. CONCLUSIONS: Our novel data suggests that young, apparently healthy, regular users of e-cigarettes present with premature vascular dysfunction in the microcirculation when compared to non-users. We have also identified systemic vascular dysfunction affecting both the micro and macrovasculature in those young individuals who used e-cigarettes for longer than 3 years. Taken together, these findings associate regular e-cigarette use with premature vascular dysfunctions and adverse cardiovascular outcomes.

Perceptions of African American Youth and Adults Regarding Tobacco Use-Related Factors in Their Community: A Mixed-Methods Approach in Richmond, Virginia.

INTRODUCTION: The US Food and Drug Administration is poised to restrict the availability of menthol cigarettes and flavored cigars, products disproportionately used by Black/African American (B/AA) individuals. We examined B/AA youth and adult perceptions regarding factors contributing to tobacco use, as well as prevention/cessation resources. METHODS: In 2 mixed-methods studies in Richmond, Virginia, we conducted cross-sectional surveys among youth (n = 201) and adult (n = 212) individuals who were primarily B/AA and reported past 30-day cigar smoking or nontobacco use, followed by focus groups with a subset (youth: n = 30; adults: n = 24). Focus groups were analyzed using a thematic analysis framework, and descriptive survey data provided context to themes. RESULTS: Among focus group participants, 20% of youth and 75% of adults reported current cigar smoking. Six themes emerged across the groups: advertising/brands, sensory experiences, costs, social factors, youth-related factors, and dependence/cessation. Youth and adults perceived cigars as popular; cigar use was attributed to targeted advertising, flavors, affordability, and accessibility. While adults expressed concern regarding youth tobacco use, youth did not perceive tobacco prevention programs as helpful. Adults and youth reported limited access to community tobacco prevention/cessation programs. DISCUSSION: Expanded tobacco prevention and cessation resources for B/AA people who smoke could leverage federal regulatory actions to ban tobacco products targeted toward this group and decrease disparities in tobacco-related morbidity and mortality.

Initial evidence of the acute effect of electronic nicotine delivery system use on energy intake.

Previous work has aimed to disentangle the acute effects of nicotine and smoking on appetite with mixed findings. Electronic nicotine delivery systems (ENDS) have yet to be examined in this regard despite evidence of use for weight control. The present study tested the influence of an ENDS on acute energy intake and associated subjective effects. Participants (n = 34; 18-65 years) with current ENDS use completed two randomly ordered clinical lab sessions after overnight abstinence from tobacco/nicotine/food/drinks (other than water). Sessions differed by the product administered over 20 min: active (20 puffs of a JUUL ENDS device; 5% nicotine tobacco-flavored pod) or control (access to an uncharged JUUL with an empty pod). About 40 min after product administration, participants were provided an ad lib buffet-style meal with 21 food/drink items. Subjective ratings were assessed at baseline, after product use, and before/after the meal. Energy intake (kcal) was calculated using pre-post buffet item weights. Repeated measures analyses of variance and pairwise comparisons were used to detect differences by condition and time (α < .05). Mean ± standard error of the mean energy intake did not differ significantly between active (1011.9 ± 98.8 kcal) and control (939.8 ± 88.4 kcal; p = .108) conditions. Nicotine abstinence symptoms significantly decreased after the active condition, while satiety significantly increased. Following the control condition, satiety remained constant while hunger significantly increased relative to baseline. Findings indicate that acute ENDS use did not significantly impact energy intake, but there was an ENDS-associated subjective increase in satiety and relative decrease in hunger. Results support further investigation of ENDS on appetite. (PsycInfo Database Record (c) 2024 APA, all rights reserved).