Switching people who smoke to unfiltered cigarettes: Effects on smoking topography.

Introduction: Smoking topography (ST) describes smoking behavior and patterns. Removal of the cigarette filter and subsequent impact on ST has not been investigated. This is the first clinical trial comparing ST for filtered and unfiltered cigarettes in a naturalistic experiment. Methods: We conducted a crossover clinical trial following established people who smoke cigarettes (n = 32) for two weeks under filtered and unfiltered smoking experimental conditions. Participants (50 % female, mean age 38.3 yr.) smoked in each experimental condition followed by a 3-week post-washout period. ST (puff count, volume, duration, peak and average flow) was measured at six time-points. Statistical analysis included a linear repeated mixed-effects model of smoking experimental conditions by visit number and sex. Results: Average flow (ml/sec) was significantly less for filtered smoking (-6.92 lower (95 % CI: -13.44 to -0.39), p < 0.05), thus demonstrating more resistance on inhalation. No significant differences were found between filtered or unfiltered experimental conditions for other ST variables. However, average volume and average peak flow were somewhat higher in unfiltered smoking, and lower mean puff counts/cigarette were observed for unfiltered compared to filtered smoking. Conclusion: Lower average flow rates were associated with filtered cigarette smoking. No significant differences were found for other ST variables between smoking experimental conditions. ST measurements comparing cigarette smoking conditions may determine if product regulatory changes, such as removing the cigarette filter could impact smoking behavioral patterns among people who smoke. This proof-of-principle study measuring ST may be replicated in larger trials to determine potential behavioral changes in smoking unfiltered cigarettes.

Change in E-cigarette risk perception and smoking behavior of Black and Latinx individuals who smoke.

INTRODUCTION: Trends in knowledge and beliefs about e-cigarette (EC) harm have been changing. Our study examined whether change in risk perception of ECs predicts cigarettes smoked per week (CPW) among Black and Latinx individuals who smoke enrolled in an EC switching randomized clinical trial (RCT). METHODS: We analyzed data from one arm of a 6-week EC RCT of individuals who smoke attempting to switch to nicotine salt pod system ECs (n = 110; Black, n = 57; Latinx, n = 53). Our explanatory variable was change in risk perception of ECs compared to combustible cigarettes (CC) from baseline to week 6. Our outcome was CPW measured by a 7-day timeline follow-back interview. A negative binomial GEE model was conducted to examine the association between risk perception and CPW at baseline and week 6. RESULTS: The mean CPW decreased from 82.8 (SD=49.8) at baseline to 15.8 (SD=29.8) at week 6. A one-level increase in EC risk perception (i.e., EC perceived as riskier than CC from baseline to week 6) was associated with an increase in CPW (IRR: 1.83, 95% CI: 1.03; 3.24). Latinx participants were more likely to have higher CPW as EC risk perception increased compared to Black participants (IRR=1.89, 95% CI: 1.09; 3.26). CONCLUSION: We found that CPW at week 6 was significantly higher as change in risk perception of EC relative to CC increased. Given the influence of risk perception on smoking behavior, people who smoke should be educated on the benefits and harms of ECs.

Switching people who smoke to unfiltered cigarettes: perceptions, addiction and behavioural effects in a cross-over randomised controlled trial.

BACKGROUND: Behavioural research is needed to inform a ban on sales of filtered cigarettes that could reduce plastic waste due to discarded filters. This study reports on differences in perceptions, nicotine dependence and behaviour among participants in a cross-over randomised trial of filtered compared with unfiltered cigarettes. METHOD: This proof-of-concept study involved 43 people who smoke filtered cigarettes (41.9% women, mean age 36.7 years). Participants were provided 2 weeks' supply of filtered cigarettes, 2 weeks of the same brand of unfiltered cigarettes and randomly assigned to starting conditions. Measures included the Modified Cigarette Evaluation Questionnaire; single-item cigarette perception questions; Fagerström Test of Nicotine Dependence; 7-day cigarette consumption, urinary cotinine and intention to quit. Analyses included linear and ordinal repeated measures mixed-effects models and paired t-tests. RESULTS: Filtered cigarettes were perceived as better tasting, more satisfying, more enjoyable, less aversive, less harsh, less potent and less negatively reinforcing than unfiltered cigarettes. Filtered cigarettes were smoked at a higher rate during the trial than unfiltered cigarettes (p<0.05). There was no difference in cotinine, dependence or intention to quit between filtered versus unfiltered cigarette conditions (p>0.05). CONCLUSION: People who smoke perceived unfiltered cigarettes as having greater nicotine effects and less desirable sensory effects than filtered cigarettes, and they smoked fewer of these during the trial. Although cotinine, dependence and intention to quit were similar for smoking unfiltered and filtered cigarettes in this small trial, results suggest that banning the sale of filtered cigarettes might make smoking less attractive overall to people who smoke. TRIAL REGISTRATION NUMBER: NCT03749876.

Role of affective reactivity induced by cigarette packaging including graphic warning labels: the CASA Study.

OBJECTIVE: To identify whether three types of cigarette pack designs, including three versions of graphic warning label (GWL) plain packs, one GWL absent and branding absent pack (blank) and the smoker's own GWL absent and branding present pack (US), elicit different valence, type and levels of affect. DESIGN: US daily smokers (n=324) were asked to handle each of the five pack types and 'think aloud' their reactions. To avoid a muted familiarity response, exposure to their own US pack followed exposure to at least one GWL plain pack. Reactions were scored on a reactivity scale (-3 to +3) and the text was coded for speech polarity (-1 to +1) and emotive word frequency. RESULTS: Reactivity scores had excellent inter-rater reliability (agreement ≥86%; intraclass correlation coefficient ≥0.89) and were correlated with speech polarity (r=0.21-0.37, p<0.001). When considering their US pack, approximately two-thirds of smokers had a low (31.5%) to medium (34.6%) positive response (reactivity=1.29; polarity=0.14) with expressed feelings of joy and trust. Blank packaging prompted a largely (65.4%) neutral response (reactivity=0.03; polarity=0.00). The gangrenous foot GWL provoked mostly medium (46.9%) to high (48.1%) negative responses (reactivity=-2.44; polarity=-0.20), followed by neonatal baby (reactivity=-1.85; polarity=-0.10) and throat cancer (reactivity=-1.76; polarity=-0.08) warnings. GWLs varied in their elicitation of disgust, anger, fear and sadness. CONCLUSION: Initial reactions to GWL packs, a blank pack, and smokers' current US pack reflected negative, neutral, and positive affect, respectively. Different versions of the GWL pack elicited different levels and types of immediate negative affect.

Evaluating US smokers' willingness to pay for different cigarette packaging designs before and after real-world exposure in a randomised trial.

INTRODUCTION: Removal of tobacco industry branding from cigarette packs may reduce their appeal. Adding graphic warning labels (GWLs) should enhance this effect. We investigate whether willingness to pay for various packaging designs changes after 3 months' use of: (1) US branded packs without GWLs (US), (2) non-branded packs without GWLs (Blank), and (3) rotating non-branded packs with GWLs (gangrene; throat cancer; neonatal baby) covering >75% of pack (GWL). METHODS: Californian adult daily smokers not planning to quit (n=287; 56% female; mean age=39.6) completed a discrete choice purchase task before and after 3 months' experience using one of three packaging options. Conjoint analysis and pre-post modelling evaluated the change in importance of pack attributes and willingness to pay for US, Blank or GWL (blindness; teeth; gangrene) pack designs. RESULTS: Price determined ~70% of purchase choices, while pack design determined ~22%. Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up. Compared with the US pack arm, using GWL packs for 3 months decreased willingness to pay for US packaging (ß=-$0.38, 95% CI -0.76 to 0.00). Wear-out effects were detected in the discount needed to willingly purchase the gangrene-GWL pack (ß=$0.49, 95% CI 0.16 to 0.82) and Blank pack (ß=$0.42, 95% CI 0.09 to 0.74) but not for GWLs (blindness, teeth) not used in trial. CONCLUSION: Compared with US branded packs, the negative valuation of non-branded GWL packs attenuates with even 3 months' use but does not generalise to non-used GWLs. This suggests that GWLs should be regularly refreshed. The appeal valuation of industry imagery suggests that the US plan to retain such imagery on packs may ameliorate the effect of GWLs.

Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial.

BACKGROUND: As the US Food and Drug Administration takes regulatory action on menthol cigarettes, debate continues about how restricting menthol e-liquids might impact adult menthol smokers in switching to e-cigarettes. METHODS: Switching patterns and e-cigarette acceptability were assessed at week 6 among 64 black and Latinx menthol cigarette smokers who used JUUL menthol (n=39) or non-menthol e-cigarettes ((n=25), primarily mint or mango) as part of a randomised switching trial. RESULTS: No clear evidence of effects was found between menthol versus non-menthol e-cigarettes on use or subjective effects/acceptability, effect sizes for all comparisons were small (effect size=0.0-0.2), and Bayes factor ranged from 0.10 to 0.15. Specifically, 82.1% of participants who used menthol-flavoured e-cigarettes fully or partially switched to e-cigarettes compared with 88.0% of participants who used a non-menthol (p=0.75). Further, both groups demonstrated substantial reductions in cigarettes per day (menthol e-cigarettes: -8.5±10.4 vs non-menthol e-cigarettes: -8.8±5.8, p=0.87), comparable grams of e-liquid consumed (menthol e-cigarettes: 9.2±9.8 g vs non-menthol e-cigarettes: 11.0±11.0 g, p=0.47), and positive subjective effects, including 'just right' throat hit (menthol e-cigarettes: 70.7% vs non-menthol e-cigarettes: 66.7%, p=0.93) and flavour liking (menthol e-cigarettes: 75.6% vs non-menthol e-cigarettes: 66.7%, p=0.32). CONCLUSIONS: Both menthol and non-menthol e-cigarettes were associated with high rates of use and acceptability among menthol smokers. Findings require confirmation in a fully powered non-inferiority or equivalence study but provide preliminary evidence to inform regulatory action on menthol e-cigarettes that could slow youth initiation without impacting black and Latinx menthol cigarette smokers interested in switching to e-cigarettes. TRIAL REGISTRATION NUMBER: NCT03511001.

Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial.

Importance: The inclusion of graphic warning labels (GWLs) on cigarette packs is recommended for tobacco control but has not yet been implemented in the US. It is unknown whether and to what extent the inclusion of GWLs on cigarette packs affects smokers' willingness to display the packs in public. Objective: To determine whether the inclusion of GWLs on cigarette packs affects pack-hiding behavior among smokers in social settings. Design, Setting, and Participants: This community-based randomized clinical trial assessed smokers' real-world experience of using cigarettes repackaged to include GWLs (GWL packs) compared with standard US packs and blank packs over a 3-month intervention period with 12 months of follow-up between September 6, 2016, and December 3, 2019. The study included 357 participants aged 21 to 65 years from San Diego County, California, who smoked 5 or more cigarettes per day, were not actively planning to quit smoking, were not pregnant, and had no unstable medical conditions. Participants purchased and received cigarette packs through the study website. Interventions: During the 1-month run-in period, participants received their usual US cigarette packs. During the 3-month intervention period, participants were randomized to receive GWL packs (study-manufactured packs with 3 rotating images under license from the Commonwealth of Australia; GWL pack group), blank packs (study-manufactured packs devoid of industry marketing imagery; blank pack group), or standard US packs (US pack group). Main Outcomes and Measures: Pack hiding was queried daily (with participants reporting behavior within the last 4 hours) and weekly via interactive text messages during the 1-month run-in and intervention periods. Self-reported smoking behavior was biochemically validated. Results: Among 357 enrolled participants, the mean (SD) age was 39.3 (11.8) years; 195 participants (54.6%) were female, 40 (11.2%) were Hispanic, 243 (68.1%) were non-Hispanic White, and 74 (20.7%) were of other non-Hispanic races (including American Indian or Alaska Native, Asian or Pacific Islander, Black or African American, or multiracial). A total of 18 987 cigarette packs were purchased and delivered during the run-in and intervention periods. Daily querying showed that the inclusion of GWLs on cigarette packs increased the percentage of smokers who hid their packs at least some of the time from 41.3% (95% CI, 39.6%-43.0%) during the run-in period to 57.1% (95% CI, 55.9%-58.1%) by the end of the intervention period. In the postintervention period, returning to standard US packs reduced pack-hiding behavior to the levels observed during the run-in period. Pack hiding remained at run-in levels for both the blank pack group (35.2%; 95% CI, 33.6%-36.8%) and the US pack group (41.4%; 95% CI, 39.7%-43.1%]) throughout the study. Although even participants in the GWL group with the lowest prestudy tendency to conceal score (ie, 1) had a mean (SE) probability of pack hiding during the intervention of 0.84 (0.02), this group's probability of pack hiding decreased to a mean (SE) of 0.43 (0.03) after intervention. When social reactions to packs were queried at the end of the study, the modal response from participants in the GWL pack group was observers' aversive reactions to the packs, whereas the modal response from participants in the blank pack group was observers' positive interest in the study. Neither smoking prevalence nor consumption differed by group at any point in the study. Conclusions and Relevance: In this randomized clinical trial, receiving cigarettes in GWL packs vs blank packs increased pack-hiding behavior in social settings, which may be associated with aversive reactions from observers. However, 12-month smoking behavior did not change. Trial Registration: ClinicalTrials.gov Identifier: NCT02676193.

Effects of Marijuana Use on Smokers Switching to E-Cigarettes in a Randomized Clinical Trial.

INTRODUCTION: Co-use of tobacco and marijuana is common, and research suggests that marijuana use may be a barrier to smoking cessation. Research to date has not evaluated how marijuana use affects e-cigarette switching behaviors and related outcomes in a harm reduction trial. AIMS AND METHODS: This secondary analysis includes African American (48%) and Latinx (52%) adult smokers randomized to the e-cigarette group (N = 114) of a harm reduction clinical trial from 2018 to 2019. Participants were provided JUUL e-cigarettes and encouraged to make an exclusive switch for 6 weeks. Our primary outcome was cigarettes smoked per week. Secondary health outcomes were e-cigarette substitution (calculated by measuring e-cigarette pod use), expired carbon monoxide (CO), and respiratory symptoms. Marijuana products were recorded at three timepoints and coded for combustion. RESULTS: Marijuana use during the study (n = 52, 46%) was not associated with week 6 cigarettes smoked or e-cigarette substitution, and combustible marijuana use was not associated with week 6 respiratory symptoms (ps > .05). After controlling for cigarettes smoked at week 6, combustible marijuana use was significantly associated with a 4.4 ppm increase in CO compared with no use of marijuana (p = .001). CONCLUSIONS: Marijuana use was not a barrier to switching to e-cigarettes in this 6-week trial. Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking. Marijuana co-use may increase risk of adverse health outcomes and may be a confounding factor when using CO as an endpoint to bioverify exclusive e-cigarette use. IMPLICATIONS: This is the first known study to examine the effects of marijuana use on smokers switching to e-cigarettes. Marijuana use was not a barrier to cigarette reduction in a 6-week randomized clinical trial. Marijuana use uniquely contributed to higher carbon monoxide among cigarette smokers, indicating greater exposure to toxic combustion products, which could increase risk of adverse health outcomes. Furthermore, combustible marijuana use may be a confounding factor when CO is used as an endpoint to bioverify exclusive e-cigarette use.

Tobacco Tracker: A New Tool to Support College Smoke and Tobacco Free Policies.

INTRODUCTION: University community members are critical to the success of their smoke and tobacco free (STF) policies. The present study evaluates changes in social enforcement-related attitudes and behaviors following introduction of a new online Tobacco Tracker tool in two university settings. METHODS: Campus wide surveys were administered to current students, faculty, and staff at two California public universities with 100% STF policies before (November 2018; N = 5078) and after (December 2019-January 2020; N = 4853) introduction of Tobacco Tracker in February 2019. Prospective surveillance reports over 12 months from Tobacco Tracker, a GIS tool for the campus community to report tobacco use and related litter that displays crowdsourced maps of hotspots, were analyzed. Outcomes included awareness and self-reported use of a tobacco reporting tool, readiness for policy social enforcement, an Intellectual Social Affective (ISA) Engagement scale, and environmental surveillance reports from Tobacco Tracker. RESULTS: In campus surveys, awareness of a tobacco reporting tool doubled (8.0%-16.9%, p < .0001), use of an online reporting tool tripled (1.1%-3.2%, p < .0001), and readiness to enforce the policy increased (p = .0008). ISA engagement did not change (p = .72). In Tobacco Tracker campus reports (N = 1163), active tobacco use was reported more frequently than tobacco-related litter. CONCLUSIONS: Tobacco Tracker is a promising tool for college communities to support STF policy. Introduction of Tobacco Tracker was associated with an increase in campus awareness and utilization of a reporting tool, readiness to enforce policy, and campus tobacco surveillance. Future research should determine how Tobacco Tracker may improve policy compliance. IMPLICATIONS: Tobacco Tracker is a promising tool for college communities to support smoke and tobacco free (STF) policy through active surveillance of smoking, vaping, and related litter on campus. Introduction of Tobacco Tracker was associated with changes in social enforcement-related attitudes and behaviors critical to realizing the preventive potential of STF policies. A crowdsourcing-based tool for monitoring tobacco use on college campuses can address a major barrier to social enforcement: discomfort confronting tobacco users. Further, it provides an alternative to punitive enforcement approaches and promises a sustainable solution to an infrastructure issue faced by many universities lacking resources to collect data on campus tobacco use and related litter.

Changes in dependence, withdrawal, and craving among adult smokers who switch to nicotine salt pod-based e-cigarettes.

BACKGROUND AND AIMS: For electronic cigarettes (e-cigarettes) to be a viable substitute for combustible cigarettes, it is likely that they must be rewarding enough for regular use, indicated by factors such as craving and dependence, important aspects of reinforcement. This study aimed to understand short-term changes in measures of nicotine dependence between groups differing by use trajectory in a switching trial, and within group changes of these measures. DESIGN: Secondary data analysis of one arm of an e-cigarette randomized clinical trial. SETTING: San Diego, California and Kansas City, Missouri, United States. PARTICIPANTS: 114 African American (n = 60) and Latinx (n = 54) smokers (58.8% male) attempting to switch to nicotine salt pod system (NSPS) e-cigarettes in a 6-week trial. MEASUREMENTS: At week 6, participants were classified by use trajectory: exclusive smokers (n = 16), exclusive e-cigarette (n = 32), or dual users (n = 66). E-cigarette, cigarette, and total nicotine dependence (cigarette + e-cigarette), use patterns, cigarette craving and nicotine withdrawal, and cotinine were assessed at baseline and week 6 using standard measures. FINDINGS: In between group comparisons, exclusive e-cigarette and dual users showed greater reductions in cigarette dependence (e-cigarette: -32.38, 95% CI = -37.7,-27.1; dual: -18.48, 95% CI = -22.2,-14.7), withdrawal (e-cigarette: -6.25, 95% CI = -8.52,-3.98; dual: -3.18, 95% CI = -5.02,-1.34), craving (e-cigarette: -11.44, 95% CI = -14.2,8.7; dual: -9.59, 95% CI = -11.6,-7.59), and cigarettes per day (CPD; e-cigarette: -11.19, 95% CI = -13.1,-9.27; dual: -9.39, 95% CI = -11.3, -7.52) compared with exclusive smokers. In within group analyses, e-cigarette and dual users showed reductions in craving and withdrawal from baseline to week 6. Exclusive e-cigarette and dual users, maintained cotinine levels (all Ps > 0.05) and showed reductions in CPD and cigarette dependence (all Ps < 0.01). Findings were inconclusive regarding changes in total nicotine dependence from baseline to week 6 among exclusive e-cigarette users (P = 0.123). Dual users showed increased total nicotine dependence (P < 0.001) and smokers showed decreased total dependence (P = 0.004). CONCLUSIONS: Smokers who switch to nicotine salt pod system e-cigarettes maintain their nicotine levels and transfer their dependence, suggesting that nicotine salt pod system e-cigarettes have a similar reinforcement potential to cigarettes and facilitate switching.

Naturalistic Topography Assessment in a Randomized Clinical Trial of Smoking Unfiltered Cigarettes: Challenges, Opportunities, and Recommendations.

Smoking topography (ST) is a set of measures profiling the behavioral characteristics of smoking in various settings. The CReSS portable device can measure ST in the natural environment. No standard protocol exists for measuring ST longitudinally with the CReSS. This study examined the utilization of the CReSS to measure ST and highlights challenges and opportunities in a naturalistic setting. This study is part of a randomized cross-over clinical trial of smoking filtered or unfiltered cigarettes. Participants (n = 43) smoked in each study condition for two weeks using the CReSS device for five days in their naturalistic smoking setting. The devices were calibrated and cleaned during the washout period, and data were downloaded every visit. Five test puffs were administered to calibrate each device. Moderate compliance rates (74.1%) were found with device usage, and the issues encountered were overheating/clogging, incorrectly registered date/time-stamped data, and device repair/replacement. Routine inspection/cleaning and training in device usage were instrumental in mitigating device malfunctioning. The CReSS device proved to be a feasible tool to examine naturalistic smoking topography and the potential impact of changes in tobacco product design on smoking unfiltered cigarettes. This is the first study to examine ST variables longitudinally, measured at multiple time points, and using unfiltered cigarettes.

The Development of a Web-Based Tobacco Tracker Tool to Crowdsource Campus Environmental Reports for Smoke and Tobacco-Free College Policies: Mixed Methods Study.

BACKGROUND: College campuses in the United States have begun implementing smoke and tobacco-free policies to discourage the use of tobacco. Smoke and tobacco-free policies, however, are contingent upon effective policy enforcement. OBJECTIVE: This study aimed to develop an empirically derived web-based tracking tool (Tracker) for crowdsourcing campus environmental reports of tobacco use and waste to support smoke and tobacco-free college policies. METHODS: An exploratory sequential mixed methods approach was utilized to inform the development and evaluation of Tracker. In October 2018, three focus groups across 2 California universities were conducted and themes were analyzed, guiding Tracker development. After 1 year of implementation, users were asked in April 2020 to complete a survey about their experience. RESULTS: In the focus groups, two major themes emerged: barriers and facilitators to tool utilization. Further Tracker development was guided by focus group input to address these barriers (eg, information, policing, and logistical concerns) and facilitators (eg, environmental motivators and positive reinforcement). Amongst 1163 Tracker reports, those who completed the user survey (n=316) reported that the top motivations for using the tool had been having a cleaner environment (212/316, 79%) and health concerns (185/316, 69%). CONCLUSIONS: Environmental concerns, a motivator that emerged in focus groups, shaped Tracker's development and was cited by the majority of users surveyed as a top motivator for utilization.

"It is the One Thing that has Worked": facilitators and barriers to switching to nicotine salt pod system e-cigarettes among African American and Latinx people who smoke: a content analysis.

BACKGROUND: Electronic cigarettes are a harm reduction strategy for individuals who smoke cigarettes who cannot or do not want to quit using FDA-approved cessation methods. Identifying perceived facilitators and barriers to switching among people who smoke cigarettes is critical to optimizing health impact. This is particularly important for the most dominant e-cigarette device, nicotine salt pod electronic cigarettes. We investigate the experience using pod electronic cigarettes among African American and Latinx individuals who smoke, the two largest racial/ethnic minority groups who experience significant health disparities. METHODS: From July 2018 to May 2019, adults who smoked cigarettes, age 21 + (N = 114; M age = 44.6, 59.6% male, 52.6% African American from Kansas City, 47.4% Latinx from San Diego) received JUUL-brand electronic cigarettes (referred to hereafter as JUUL) for 6 weeks and answered interview questions at week six. We inquired what they liked and disliked about using JUUL, what helped with switching and made switching difficult, future intentions for continued JUUL use, and how JUUL compared to past smoking reduction methods. Responses were coded into themes by independent raters. Theme frequencies were analyzed separately by race/ethnicity and week 6 use trajectory (exclusive JUUL use, dual JUUL and cigarette use, exclusive cigarette use). RESULTS: Clean/smell was the aspect of using JUUL most commonly liked (23%), followed by convenience (19%). Coughing/harshness was a more common barrier to switching for African American (44%) than Latinx (9%), and for continuing cigarette use (56%) than for those who exclusively switched or dually used JUUL and combustible cigarettes (15-21%). Most (78% African American; 90% Latinx) reported that the benefits of using JUUL outweighed barriers, and this varied by JUUL use trajectory: 94% exclusive switch, 86% dual use, and 42% continued cigarette use. The majority said they would continue using JUUL to replace cigarettes (83% African American; 94% Latinx) and that JUUL worked better than other methods to reduce cigarettes (72%). CONCLUSION: African American and Latinx individuals who smoked experience using pod electronic cigarettes was generally positive. Understanding facilitators and impediments to switching to electronic cigarettes among racial/ethnic minority people who smoke can inform harm reduction interventions and reduce tobacco-related health disparities. Trial Registration ClinicalTrials.gov Identifier: NCT03511001 posted April 27, 2018.

Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial.

Importance: The US Food and Drug Administration's implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts. Objective: To determine whether GWLs can affect US smokers' perceptions about their cigarettes or health consequences and changes in smoking behavior. Design, Setting, and Participants: This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging. Community recruitment was done from September 2016 through December 2019 of daily smokers from San Diego, California, aged 21 to 65 years, who were not ready to quit. Participants were randomized to purchase and receive cigarettes in 1 of 3 pack designs: GWL, blank, or standard US pack. Data analysis was performed from July 2020 to February 2021. Interventions: The study manufactured GWL cigarette packs (3 versions with Australian-licensed images) and packs devoid of marketing. For 3 months, participants purchased GWL, blank, or standard US pack cigarettes that were delivered to their home. Main Outcomes and Measures: Smoking-related cognitions and behavior were queried by daily and weekly interactive text messages. Smoking behavior was self-reported before and after the intervention by 96% of randomized participants and was biochemically validated on a subsample. Results: The study sample included 357 participants (195 women [54.6%]; mean [SD] age, 39.5 [11.9] years); 116 were randomized to the standard US pack group, 118 were randomized to the GWL pack group, and 125 were randomized to the blank pack group. Over the 3 months, participants who received the GWL packs had reduced positive perceptions of recent cigarettes smoked compared with participants who received the branded US pack (mean difference, -0.46 SD; 95% CI, -0.73 SD to -0.20 SD; P < .001). Health concerns increased in all groups, with a significant increase in the GWL group vs the US pack group (mean difference, 0.35 SD; 95% CI, 0.09 SD to 0.62 SD; P = .002). Quitting cognitions increased in all study groups, with a peak mean change of 0.60 SD for GWL participants vs 0.34 SD for US pack participants (mean difference, 0.55 SD; 95% CI, 0.28 SD to 0.81 SD; P < .001). GWL participants had slightly more cigarette abstinence periods per week than the US pack group, but the difference was not significant (adjusted odds ratio, 1.06; 95% CI, 0.99 to 1.13). At 3 months, there was no between-group difference in any smoking behavior. The blank pack group was similar to the US pack group on all measures. Conclusions and Relevance: These findings suggest that the introduction of GWL packs appears to decrease positive perceptions of cigarettes and increase quitting cognitions in the short term. However, additional complementary tobacco control strategies may be necessary for GWL packs to be associated with reduced smoking behavior. Trial Registration: ClinicalTrials.gov Identifier: NCT02676193.

Young Adult E-cigarette Use and Retail Exposure in 6 US Metropolitan Areas.

OBJECTIVES: Given the need to understand e-cigarette retail and its impact, we examined sociodemographic, tobacco and marijuana use, and e-cigarette retail experiences as correlates of (1) past 30-day e-cigarette use, (2) past 30-day advertising/media exposure, and (3) point-of-sale age verification among young adults. METHODS: We analyzed baseline survey data (September-December, 2018) among 3006 young adults (ages 18-34) in 6 metropolitan areas (Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, Seattle) in a 2-year longitudinal study. RESULTS: In this sample (Mage = 24.6, 42.3% male, 71.6% white, 11.4% Hispanic), 37.7% (N = 1133) were past 30-day e-cigarette users; 68.6% (N = 2062; non-users: 66.0%, users: 72.9%) reported past 30-day e-cigarette-related advertising/media exposure. Among e-cigarette users, vape shops were the most common source of e-cigarettes (44.7%) followed by online (18.2%). Among users, 34.2% were "almost always" asked for age verification. In multilevel logistic regression, e-cigarette use and advertising/media exposure were correlated (and both correlated with being younger). E-cigarette use also correlated with other tobacco product and marijuana use (and being male and white). Infrequent age verification correlated with commonly purchasing e-cigarettes online (and being older and black). CONCLUSIONS: Increased efforts are needed to reduce young adult advertising/media exposure and increase retailer compliance among retailers, particularly online and vape shops.

Predictors of smoking reduction among African American and Latinx smokers in a randomized controlled trial of JUUL e-cigarettes.

INTRODUCTION: E-cigarette (e-cig) use is widespread and may play an important role in facilitating smoking reduction. Racial/ethnic minorities are less likely than Whites to use e-cigs and suffer disproportionate tobacco-related disease, making them a priority for harm reduction. This paper explores factors associated with smoking reduction among African American (AA) and Latinx smokers enrolled in a trial assessing toxicant exposure in those assigned to e-cigs or smoking as usual. METHODS: Participants were randomized to receive 6 weeks of JUUL e-cigs or continue smoking cigarettes as usual (N = 187). This analysis focuses on 109 participants randomized to e-cigs. We modeled cigarettes smoked in the past week at baseline and week 6 as a function of a priori selected predictors (number of JUUL pods used throughout the study, baseline cigarette dependence, and baseline cotinine) using a Poisson model fit with generalized estimating equations. RESULTS: Over the six-week study, cigarette smoking decreased from an average of 82.4 to 15.5 cigarettes per week. Greater numbers of JUUL pods used predicted a greater smoking reduction by week 6 (IRR = 0.94 [0.91, 0.96], p < 0.001). Higher baseline cigarette dependence (IRR = 1.03 [1.01, 1.05], p = 0.004), and baseline cotinine (IRR = 1.18 [1.03, 1.37], p = 0.020) predicted a lesser smoking reduction. CONCLUSIONS: AA and Latinx smokers reduced their cigarette consumption while using JUUL e-cigs. Higher e-cig use during an intervention to switch to e-cigs to reduce harm may facilitate a transition to smoking fewer cigarettes, offering an opportunity to narrow smoking-related health disparities.

Harm Reduction Associated with Dual Use of Cigarettes and e-Cigarettes in Black and Latino Smokers: Secondary Analyses from a Randomized Controlled e-Cigarette Switching Trial.

INTRODUCTION: Most adult cigarette smokers who use e-cigarettes are dual cigarette and e-cigarette (CC-EC) users, yet little is known about relative consumption of cigarettes to e-cigarettes and any associated harm reduction. METHODS: Rate of substitution from cigarettes to e-cigarettes at week 6 and change in biomarkers of exposure and potential harm were examined among dual dual cigarette and e-cigarette users [64/114 (56%); 35 Black, 29 Latino] in an e-cigarette switching randomized trial. RESULTS: Dual users averaged 79% substitution of cigarettes for e-cigarettes at week 6, resulting in a reduction from baseline of 70.0 ± 54.1 cigarettes per week (p < .001). Total nicotine consumption remained stable (baseline: 1160.5 ± 1042.1 pg/mL of cotinine, week 6: 1312.5 ± 1725.9 pg/mL of cotinine, p = .47), while significant reductions were seen in the potent lung carcinogen 4-(methylnitrosamino)-1-(3-pyridul)-1-butanol (NNAL) (-55.9 ± 88.6 ng/ml, p < .001), carbon monoxide (-6.3 ± 8.6 ppm, p < .001), and self-reported respiratory symptoms (-3.3 ± 8.0, p = .002). No significant changes were found in blood pressure or spirometry. Greater substitution from cigarettes to e-cigarettes was associated with larger reductions in NNAL (r = -.29, p = .02). CONCLUSIONS: The predominant dual-use pattern was characterized by regular e-cigarette and intermittent cigarette use. Findings demonstrate the short-term harm reduction potential of this dual-use pattern in Black and Latino smokers and suggest that the greatest benefit, aside from cessation of both products, is achieved by higher substitution of e-cigarettes for cigarettes. Findings need confirmation in a larger sample with longer follow-up in dual users with greater variability in the rate of substitution. CLINICALTRIALS.GOV IDENTIFIER: NCT03511001. IMPLICATIONS: Findings suggest short-term harm reduction potential of dual cigarette-e-cigarette use for Black and Latino smokers. Results also demonstrate the heterogeneity of dual-use, with the greatest harm reduction seen in dual users with higher rates of substitution from cigarettes to e-cigarettes. Study results should be confirmed in a full clinical trial with long-term follow-up to evaluate maintenance of dual-use patterns and associated harm reduction potential over time.

Young Adults' Vaping, Readiness to Quit, and Recent Quit Attempts: The Role of Co-use With Cigarettes and Marijuana.

INTRODUCTION: E-cigarette cessation intervention research is limited. Young adult e-cigarette use and cessation is particularly nuanced, given various user profiles (ie, polytobacco use, co-use with marijuana) warranting different intervention approaches. METHODS: The current study is an analysis of baseline survey data (collected September-December 2018) among 1133 young adult (aged 18-34) e-cigarette users in a 2-year longitudinal study. We examined (1) e-cigarette user profiles (ie, e-cigarette only; e-cigarette/other tobacco; e-cigarette/marijuana; e-cigarette/other tobacco/marijuana) and (2) correlates of readiness to quit e-cigarette use in the next 6 months and past-year e-cigarette quit attempts. RESULTS: In this sample (Mage = 23.91, 47.3% male, 35.5% sexual minority, 75.2% White, 13.7% Hispanic), e-cigarette user profiles were as follows: 16.8% e-cigarettes-only, 23.4% e-cigarette/other tobacco, 18.0% e-cigarette/marijuana, and 41.8% e-cigarette/other tobacco/marijuana. Multinomial logistic regression (referent: e-cigarette-only use) indicated that all polyuse groups were more likely to use high-nicotine e-liquids (containing ≥9 mg of nicotine). Other predictors included e-cigarettes/other tobacco users being older and male; e-cigarettes/marijuana users using closed systems; and e-cigarettes/other tobacco/marijuana users being sexual minority (p's < .01). Readiness to quit e-cigarettes and past-year quit attempts were reported by 20.8% and 32.3%, respectively. Per multilevel regression, readiness to quit and quit attempts correlated with using fewer days, high-nicotine e-liquids, and closed systems, but not marijuana, as well as being heterosexual and Black (vs White); readiness to quit also correlated with being single; past-year quit attempts correlated with other tobacco use and being Hispanic. CONCLUSIONS: Young adult e-cigarette users demonstrate distinct user profiles and cessation-related experiences that should be considered in developing cessation interventions. IMPLICATIONS: The vast majority of young adult e-cigarette users use other tobacco products and marijuana. Unfortunately, few reported readiness to quit or attempting quit. Moreover, certain subgroups (eg, sexual/racial/ethnic minorities) are more likely to be ready or attempt to quit, but may not be successful. Vaping cessation interventions must attend to these nuances.

JUUL E-Cigarette Quit Attempts and Cessation Perceptions in College Student JUUL E-Cigarette Users.

PURPOSE: This study describes the frequency of JUUL e-cigarette (referred to as JUUL) quit attempts and identifies characteristics associated with confidence in quitting and perceived difficulty quitting JUUL. DESIGN: Cross-sectional study from a self-administered online survey. SETTING: Two public southern California universities. PARTICIPANTS: A total of 1,001 undergraduate students completed the survey from February to May 2019. MEASURES: Self-report measures about JUUL included use, history of quit attempts, time to first use, perceived difficulty with cessation/reduction, and confidence in quitting. ANALYSIS: Binary logistic regressions were used to identify demographic and tobacco-related behavioral correlates of JUUL cessation-related perceptions and behaviors. RESULTS: Nearly half of ever-JUUL users (47.8%) reported a JUUL quit attempt. Adjusting for demographic factors and other tobacco product use, shorter time to first JUUL use after waking was associated with lower confidence in quitting JUUL (aOR = 0.02, 0.00-0.13) and greater perceived difficulty in quitting JUUL (aOR = 8.08, 2.15-30.35). Previous JUUL quit attempt history was also associated with greater odds of perceived difficulty quitting JUUL (aOR = 5.97, 1.74-20.53). CONCLUSIONS: History of JUUL quit attempts among college students was common. Those who had previously tried quitting were more likely to perceive difficulty with cessation. Time to first JUUL use, a marker of dependence, was linked with greater perceived cessation difficulty and lower confidence in quitting. These findings suggest that there is a need for cessation and relapse prevention support for college student JUUL users.

Vape Shop Owners/Managers' Opinions About FDA Regulation of E-Cigarettes.

INTRODUCTION: In the United States, prominent sources of vaping products are specialty vape shops, which are subject to Food and Drug Administration (FDA) regulation. This study interviewed vape shop owners/managers to assess: (1) reasons for entering into or engaging in vape shop retail; (2) personnel training, particularly with regard to FDA and state regulations; and (3) how existing regulations are perceived and the anticipated impact of future regulation. AIMS AND METHODS: The current study involved phone-based semi-structured interviews of 45 vape shop owners/managers in six metropolitan statistical areas (Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, and Seattle) during Summer 2018 as FDA regulations regarding minimum age verification, bans on product sampling, and health warnings (among others) were first being implemented. RESULTS: Vape shop owners/managers reported: (1) entering the industry with positive intentions for their customers, (2) training their personnel to adhere to regulations and provide good customer service, and (3) significant concerns about the impact of FDA regulations. With regard to the latter, participants reported mistrust of the intentions of the FDA regulations, financial implications of the regulations (particularly for small businesses), difficulty understanding and interpreting the regulations, insufficient evidence to support the regulations, negative impact on customer service, negative impact on product offerings and product innovation/advancement, and negative implications of flavor bans and/or restrictions on sale of flavors. CONCLUSIONS: These findings indicate the complexities in implementing tobacco regulations, particularly from the perspective of the vape shop industry. Current findings should inform future regulatory actions and efforts to assess compliance with regulations. IMPLICATIONS: Current and impending FDA regulation of vaping products present a critical period for examining regulatory impact on the vape shop industry. Current results indicated that many vape shop owners/managers reporting positive intentions for engaging in the vaping product industry and in training vape shop personnel to adhere to regulations. However, the majority reported concerns about FDA regulation and other state/local regulations that could have negative implications for their industry. Particular concerns include difficulty understanding the regulations due to complexity, vagueness, and changes in language and/or interpretation over time. These issues have implications for compliance that must be addressed.