Differential responses to cigarette package labeling alternatives among adults who smoke: Results from a randomized trial.

INTRODUCTION: Little experimental research has evaluated whether the effects of cigarette package inserts with efficacy messages and/or pictorial health warning labels (PHWLs) differ across key subgroups of adults who smoke. METHODS: Adults who reported currently smoking (n=367) were randomly assigned to one of four groups: small text-only health warning labels (HWLs) on pack sides (control); inserts with efficacy messages and small HWLs (inserts-only); PHWLs showing harms of smoking (PHWLs-only); both (inserts+PHWLs). Participants received a 14-day supply of cigarettes labeled to reflect their group. Every evening over two weeks, participants reported forgoing and stubbing out cigarettes before they finished smoking over the prior 24 hours, combined into a binary indicator of either behavior (e.g., forgoing/stubbing). Separate mixed-effects logistic models were estimated to evaluate moderation of labeling group contrasts (i.e., PHWLs vs not; inserts vs. not; inserts-only vs. inserts+PHWLs; PHWLs-only vs. inserts+PHWLs) by baseline covariates (self-efficacy to quit, intention to quit, education, health literacy, time discounting), predicting day-level forgoing/stubbing. RESULTS: Education moderated PHWL effects, with PHWLs predicting more forgoing/stubbing only among those with low education (OR=4.68, p<0.001). Time discounting moderated insert effects, with inserts promoting fogoing/stubbing only among those with low time discounting (i.e., lower impulsivity; OR=4.35, p<0.001). CONCLUSIONS: Inserts with efficacy messages appear effective mostly among people with low time discounting, whereas PHWLs appear most effective amongst those with low education, suggesting their potential to address education-related disparities. Labeling strategies appeared equally effective across subgroups defined by self-efficacy to quit, quit intention, and health literacy. Combining inserts with PHWLs did not appear to mitigate moderation effects. IMPLICATIONS: This randomized trial with adults who smoke suggests that cigarette packs with inserts describing cessation benefits and tips can promote cessation-related behaviors (i.e., forgoing or stubbing out cigarettes) among those with low time discounting (i.e., low impulsivity). Alternative interventions may be needed for people with high time discounting, as found in cessation trials. Pictorial health warning labels (PHWLs) appear most effective among those with low education, potentially addressing education-related disparities. No differential effects were found for those with different levels of self-efficacy to quit, quit intentions, or health literacy. Combining inserts and PHWLs may not be more effective than either alone.

Self-reported attention and responses to cigarette package labels at the end of a two-week randomized trial of cigarette package labeling configurations.

INTRODUCTION: Cigarette package inserts that describe quitting benefits and tips may promote cessation; however, research is needed to understand better their effects, including potentially enhancing the effects of pictorial health warning labels (PHWLs). METHODS: A randomized trial with a 2×2 factorial design was conducted with adult smokers (n=356) assigned to either small text-only health warning labels (HWLs; control); inserts with cessation messages, and the small text-only HWLs (inserts-only); large PHWLs (PHWLs-only); both inserts and PHWLs (inserts + PHWLs). Participants received a 14-day supply of their preferred cigarettes with packs labeled to reflect their group. Upon finishing the trial, participants reported their past 14-day frequency of noticing, reading, thinking about smoking harms and cessation benefits, talking about labels, and forgoing cigarettes because of the labels. Ordered logistic models regressed these outcomes on labeling groups, and mediation analyses assessed whether attention (i.e. noticing, reading) to labels mediated effects of labeling exposure on other outcomes (i.e. thinking about harms/benefits, talking, forgoing). RESULTS: The inserts + PHWLs group reported higher frequencies than the control group for all outcomes. Compared to the control group, both the inserts-only and PHWLs-only groups reported higher frequency of noticing (AOR=3.53 and 2.46, respectively) and reading labels (AOR=2.89 and 1.71), thinking about smoking risks because of the labels (AOR=1.93 and 1.82), and talking about labels (AOR=2.30 and 2.70). Participants in the inserts-only group also reported more frequent thinking about quitting benefits (AOR=1.98). Attention mediated all labeling effects except for the contrast between PHWLs only and control. CONCLUSIONS: Compared to text-only HWLS, cigarette labeling that involves inserts, PHWLs, or both appears more effective at drawing attention to warnings, which mediated the effects on cessation-related psychosocial and behavioral outcomes.

Barriers to smoking interventions in community healthcare settings: a scoping review.

Smoking is one of the major causes of preventable death and is considered the greatest threat to global public health. While the prevalence of smoking has decreased, population growth has led to an increase in the absolute number of smokers. There are many proven smoking cessation interventions available to support smokers in their quit attempts. Most people who smoke, however, underutilize the treatments available to them. This scoping review aimed to identify the current barriers experienced by all stakeholders (smokers, service providers and policymakers) to existing evidence-based smoking cessation interventions in community healthcare settings. Five electronic databases (CINAHL, Ovid MEDLINE, PsycINFO, Scopus and Web of Science) were searched for relevant literature. A total of 40 eligible articles from different countries published between 2015 and 2022 were included in the review and content analysis carried out to identify the key barriers to smoking cessation interventions. Seven key themes were found to be common to all stakeholders: (i) literacy, (ii) competing demands and priorities, (iii) time, (iv) access to product, (v) access to service, (vi) workforce and (vii) motivation/readiness. These themes were mapped to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. This study presents the effect the barriers within these themes have on current smoking cessation services and highlights priorities for future interventions.

Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Recruitment Methods, Inclusion, and Successful Participation in a Longitudinal Clinical Trial Using Ecological Momentary Assessment.

Underrepresentation of historically marginalized populations in clinical trials continues to threaten the validity of health intervention research. Evidence supports the merits of intercept and other proactive forms of recruitment for achieving more equitable representation. However, researchers also report lower retention and adherence to protocols among these populations, particularly in longitudinal studies. Few studies have compared recruitment methods for longitudinal randomized trials testing health interventions, with even fewer having done so for trials involving ecological momentary assessment (EMA). As intervention research integrates EMA and other data collection approaches requiring substantial participant effort, it is critical to better understand the effectiveness and implications of strategies to improve the representativeness of health research. This secondary data analysis compared outcomes of proactive and reactive recruitment strategies (mobile lab intercepts and internet/flyer advertising, respectively) in study inclusion, task completion, and retention within a 14-day randomized controlled trial that used EMA to evaluate cigarette package health messages. Proactive recruitment resulted in higher proportions of participants with low income and education, limited health literacy, and of diverse racial/ethnic makeup. However, this recruitment method also resulted in lower task completion, especially in the second week of the trial period, and lower retention, although group differences were not explained by participant sociodemographic characteristics targeted by inclusion efforts. We conclude that proactive recruitment via intercepts is an effective strategy for health intervention research that aims to include stakeholders from historically marginalized groups but that researchers and funders must recognize these methods require additional resources, considerations, and capacity to address non-trivial challenges to successful participation.

A mixed-method study of perceptions of cigarette pack inserts among adult smokers from New York and South Carolina exposed as part of a randomized controlled trial.

While many countries require prominent pictorial health warning labels (PHWLs) on the outside of cigarette packs to communicate the harms of smoking, there is evidence that cigarette pack inserts that contain efficacy messages may enhance the effectiveness of PHWLs. The US Food and Drug Administration (FDA) has regulatory authority to communicate with smokers through inserts. While current labeling regulations do not require inclusion of inserts, the FDA could implement them in the future. This study assesses US smokers' perceptions of cigarette package inserts at the conclusion of a two-week randomized trial on cigarette labeling where half of participants were exposed to insert messages (two response-efficacy messages and two self-efficacy messages) in their packs. Participants (n = 359) completed a 30- to 60-min interview with both quantitative and qualitative assessments, including measures of recall and perceived message effectiveness (PME) for specific inserts. Correlates of recall and PME were estimated using mixed-effects regression models. Qualitative responses to PME items were analyzed using thematic analysis. Response-efficacy messages had higher PME and recall than self-efficacy messages. People had diverse responses to the inserts, including that they were positive, thought-provoking, and helpful. Reactions to and perceptions of the inserts indicate potential benefits of integrating efficacy messages into labeling policies.

A Pilot Randomised Trial Investigating the Effects of Including Efficacy Messaging on Tobacco Warning Labels.

INTRODUCTION: Smokers can respond defensively to health risk communication such as on-pack warning labels, potentially reducing their effectiveness. Theory suggests that risk perception together with self-efficacy reduces defensive responses and predicts target behaviors. Currently, tobacco warning labels globally predominantly target risk and do not explicitly consider efficacy. AIMS: This study explores the effectiveness of combining Australian tobacco warning labels with efficacy content to increase quitting intentions. METHODS: RCT in 83 smokers over 3 weeks. After a seven-day baseline phase (smoking from usual tobacco packaging), participants were randomized to one of two adhesive labels groups for the remaining 14 days: Standard health warning labels (HWLs) featuring enhanced efficacy messages (experimental group) or unmodified standard HWLs (control group). Participants attached these labels to their tobacco packaging and recorded their cognitions and smoking behavior once daily using Smartphones. Multilevel structural equation modeling was used to test theorized effects of the labels on self-efficacy, risk perception, and intentions to quit. RESULTS: There was no effect of exposure to efficacy messages on either self-efficacy, risk perceptions, or intentions to quit. However, self-efficacy and risk perceptions were positively associated with quitting intentions at the within-person level. CONCLUSIONS: The predictive relationships between self-efficacy, risk perception, and intention to quit were supported, however, supplementing standard warning labels with efficacy messages had no effect on these cognitions. Whether this is due to conditioned avoidance of HWLS, characteristics of the messages, or limitations imposed by format are unclear. IMPLICATIONS: Self-efficacy and risk perception predict intentions to quit smoking. Adding efficacy content to tobacco health warnings may have the potential to bolster these cognitions but more research is required to determine the contexts in which this would be effective and who would be likely to benefit. The time course by which exposure to efficacy content might influence cessation self-efficacy and downstream quitting intentions also needs to be investigated.

Co-occurrence of food addiction, obesity, problematic substance use, and parental history of problematic alcohol use.

OBJECTIVE: The present study investigates the rates of co-occurrence among food addiction (FA), problematic substance use (alcohol, cannabis, cigarettes, nicotine vaping), parental history of problematic alcohol use, and obesity as an important step to understanding whether an addictive-like eating phenotype exists. METHOD: A community sample of 357 U.S. adults (49.7% male, 77.6% White, Mage 40.7) completed the Yale Food Addiction Scale 2.0 (YFAS2.0), the Alcohol Use Disorders Identification Test, the Cannabis Use Disorders Identification Test, the Fagerstrom Test for Nicotine Dependence, the E-Cigarette Dependence Scale, the Family Tree Questionnaire, and demographic/self-report body mass index questions through Amazon Mechanical Turk. Risk ratios (RRs; unadjusted and adjusted for sociodemographic covariates) were calculated using modified Poisson's regression. RESULTS: Risk of FA was higher in participants with problematic alcohol use (RR = 2.13, 99% CI [1.32, 3.45]), smoking (RR = 1.86, 99% CI [0.82, 3.36]), cannabis use (unadjusted; RR = 2.22, 99% CI [1.17, 4.18]), vaping (RR = 2.71, 99% CI [1.75, 4.21]), and parental history of problematic alcohol use (RR = 2.35, 99% CI [1.46, 3.79]). Risk of FA in participants with obesity was only higher in adjusted models (RR = 1.87, 99% CI [1.06, 3.27]). Obesity was not significantly associated with problematic substance use and parental history of problematic alcohol use. CONCLUSIONS: FA, but not obesity, co-occurred with problematic substance use and a parental history of problematic alcohol use. Results support the conceptualization of FA as an addictive disorder. The inclusion of FA as an addictive disorder in diagnostic frameworks is an important area of future consideration. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Withdrawal: A key consideration in evaluating whether highly processed foods are addictive.

Researchers are currently debating whether theories of addiction explain compulsive overeating of highly processed (HP) foods (i.e., industrially created foods high in refined carbohydrates and/or fat), which contributes to obesity and diet-related disease. A subset of individuals consumes HP foods with behavioral phenotypes that mirror substance use disorders. Withdrawal, the emergence of aversive physical and psychological symptoms upon reduction or cessation of substance use, is a core component of addiction that was central to historical debates about other substances' addictive potential (e.g., nicotine and cocaine). However, no one has systematically considered evidence for whether HP foods cause withdrawal, which represents a key knowledge gap regarding the utility of addiction models for understanding compulsive overeating. Thus, we reviewed evidence for whether animals and humans exhibit withdrawal when reducing or eliminating HP food intake. Controlled experimental evidence indicates animals experience HP food withdrawal marked by neural reward changes and behaviors consistent with withdrawal from other addictive substances. In humans, preliminary evidence supports subjective withdrawal-like experiences. However, most current human research is limited to retrospective recall. Further experimental research is needed to evaluate this construct. We outline future research directions to investigate HP food withdrawal in humans and consider potential clinical implications.

Design of Financial Incentive Programs for Smoking Cessation: A Discrete Choice Experiment.

INTRODUCTION: Financial incentive programs promote smoking cessation. However, the incentive amount which should be provided-and how this may interact with other program characteristics-is unknown. The objective of this study was to evaluate the influence of the design of incentive programs for smoking cessation on current smokers' perceptions of programs and willingness to enroll. METHOD: An online discrete choice experiment was conducted amongst adult current smokers residing in the United Kingdom (N = 430). Hypothetical incentive programs were described using five attributes (incentive amount, incentive type, frequency of sessions, reward schedules, program location). Participants responded to a series of choice sets comprised of two hypothetical programs. For each set, participants selected their preferred program. They then specified whether they would enroll in their preferred program if it were available. Analyses also considered the effect of participant income on preferences. RESULTS: Overall, participants preferred higher amounts over lower amounts, cash over vouchers, healthcare settings over workplaces, and consistent amounts over an escalating schedule. One session per week was the most preferred session frequency. Willingness to enroll increased quadratically with the incentive amount, although this increase slowed for higher amounts. Although middle- and high-income smokers preferred slightly higher amounts (cf. low-income participants), enrollment choices did not differ by income. CONCLUSION: The characteristics of incentive programs influence smokers' perceptions of programs and willingness to enroll. Higher amounts may encourage greater enrollment rates, but there will likely be a ceiling point beyond which increasing the incentive amount does not meaningfully increase enrollments. IMPLICATIONS: There is increasing evidence incentive programs aid smoking cessation. Yet, the variety in previous program designs means how to best structure programs, including optimal incentive amount and the impact of the design on potential enrollment rates, remains unclear. This study suggests enrollments may be highest when incentive amounts are higher, rewards of a consistent amount in cash are provided, and sessions occur once per week in a healthcare setting. Although higher-income participants may desire higher incentive amounts compared to lower-income participants, this may not translate into differences in willingness to enroll.

Measurement of cigarette smoking: Comparisons of global self-report, returned cigarette filters, and ecological momentary assessment.

Prior work suggests that prospective measurement of cigarette use may be more reliable and valid than retrospective self-reports. Despite several studies comparing retrospective and prospective methods, there are a myriad of prospective methods that have not been directly compared, including spent cigarette filters that are returned to the laboratory by participants and diary logs of cigarette use on an electronic device via ecological momentary assessment. The current secondary data analysis compared the reliability of retrospective global self-report, returned cigarette filters, and electronic diary logs among a sample of cigarette smokers that also use smokeless tobacco (SLT; N = 51) over two consecutive weeks. CPD values also were compared to salivary cotinine levels to determine whether any method was associated more strongly with nicotine/tobacco exposure. Results indicated that CPD values via global self-report were significantly larger than returned filter and diary log daily averages across both weeks (t(50) = 8.28 to 9.35; p < .001). Both prospective measures showed less digit bias and more variation in smoking behavior across days than global self-reports. Only returned CPD values were correlated significantly with salivary cotinine levels (r(593) = 0.09, p = .024). Importantly, most reliability outcomes for returned filters and logged CPD did not differ significantly, suggesting that they may be comparable prospective methods for measuring cigarette use. Because returned filters and diary logs did not differ from one another, researchers' selection of a prospective measurement method should rely on considerations of participant compliance, protocol burden, and specific research questions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

Incentives for smoking cessation in a rural pharmacy setting: The Tobacco Free Communities program.

OBJECTIVE: Investigate the smoking-related outcomes and feasibility of a pharmacy-led financial incentive program for smoking cessation. DESIGN: Multi-site single-arm trial of the Tobacco Free Communities program. SETTING: Community pharmacies within the Glamorgan Spring Bay (Site 1) and George Town (Site 2) municipalities of Tasmania. PARTICIPANTS: Adult smokers. Based on funding, the recruitment target was 76 smokers. INTERVENTIONS: Pharmacy staff provided quitting advice through 7 sessions over 3 months. At 6 sessions, abstinent participants (no cigarettes in the previous week and expired carbon monoxide ≤4 ppm) were rewarded with AU$50 vouchers. MAIN OUTCOME MEASURES: Smoking-related outcomes were decreased smoking (self-reported cigarettes per day and carbon monoxide levels) and abstinence rates. Feasibility outcomes were meeting the recruitment target, participant retention and participants' views of the program (measured by interview data from Site 2). RESULTS: Ninety individuals enrolled. Sixty-two participants were included in analyses; remaining participants were excluded from analyses because they did not consent to use of their data within this study or had carbon monoxide ≤4 ppm at enrolment. Smoking (carbon monoxide and cigarettes per day) significantly decreased between enrolment and the first financial incentive session. Twelve participants (19.35%) were abstinent at the end of the program. Yet retention was poor; only 13 participants (20.97%) attended all sessions. Interviews suggested participants found the program beneficial. CONCLUSIONS: Providing financial incentive within rural community pharmacies could be a viable method of encouraging smoking reductions and quit attempts. Additional work is needed to increase retention and compare effects to usual care pharmacy practices.

Smokers' Perceptions of Incentivized Smoking Cessation Programs: Examining How Payment Thresholds Change With Income.

INTRODUCTION: Studies demonstrate that financial incentive programs increase smoking cessation. However, there is little guidance on which incentive magnitudes will ensure optimal enrollment and motivation levels. This study investigates current smokers' perceptions of varying incentive magnitudes to identify whether there is evidence for optimal amount(s) and whether perceptions differ by income group. METHODS: Studies 1 (N = 56) and 2 (N = 147) were conducted online via Prolific.co. Current smokers were randomly shown multiple hypothetical incentive programs that differed only in the incentive amount offered. For each program, smokers rated its appeal and their likelihood of enrolling and predicted their motivation to quit if enrolled. Growth models were used to investigate the relationship between perspectives and the incentive amount. RESULTS: An increasing quadratic trend in smokers' perceptions of programs as the incentive amount increased was identified. Incentive amounts beyond approximately £50-75 per week (£500-£750 total) did not significantly alter perceptions of programs. In Study 2, high-income smokers found programs significantly less appealing and motivating than low-income smokers, although no significant between-group differences were observed in the likelihood of enrollment. No significant differences were observed between low- and middle-income smokers. CONCLUSIONS: Increasing the incentive amount increased smoker's perceptions of programs. This relationship was curvilinear, meaning there may be a point beyond which further increasing the amount will not improve enrollment or motivation levels. Incentives appear equally appealing to low- and middle-income smokers; the population among whom smoking is most prevalent. Future research could explore other elements of program design and whether findings hold under real-world conditions. IMPLICATIONS: While acknowledging that they work, policymakers frequently request information about the monetary amount needed for incentive programs to be effective, and if this differs by income level. We investigated these questions using smokers' perceptions of hypothetical cessation programs that differed in the amount offered. An increasing quadratic trend in perceptions of programs by the amount and potential cut points was observed, suggesting a point may exist beyond which increasing the incentive will not improve perceptions of programs or enrollment levels. High-income smokers may not perceive incentives to be as appealing as other income groups, but appear equally willing to enroll.

Cigarette smokers' concurrent use of smokeless tobacco: dual use patterns and nicotine exposure.

BACKGROUND: The concurrent use of cigarettes with other tobacco products, such as smokeless tobacco (SLT), is increasingly common. Extant work with cigarette smokers who also use SLT is based heavily on retrospective reports and between-group comparisons. The purpose of this study was to assess prospectively the patterns of dual users' product use and nicotine exposure on days when cigarettes were smoked exclusively (single use) versus concurrently with SLT (dual use). DESIGN: Forty-six dual cigarette-SLT users recorded their product use in real time via ecological momentary assessment for a 2-week longitudinal design. They responded to questions about situational factors (eg, location, mood) using this same diary, and collected saliva samples each night for later cotinine measurement. At the end of this 2-week period, users reported on their reasons for and beliefs about SLT use. RESULTS: Cotinine levels were significantly higher on dual versus single use days (mean±SEM=374.48±41.08 ng/mL vs 300.17±28.13 ng/mL, respectively; p<0.01), and the number of cigarettes logged was higher on dual versus single use days (11.13±0.98 vs 9.13±1.11, respectively; p<0.01). Product use was distinguished by situational factors, with the strongest predictor being location of use. Moreover, the most common reason for initiating (56.52%) and continuing (67.39%) SLT use was to circumvent indoor smoking restrictions. CONCLUSIONS: Results support the idea of product supplementation rather than replacement among this convenience sample of dual users. For smokers whose primary motivation for SLT use involves situations where they would otherwise be tobacco free, the potential benefits of clean indoor air laws may be diminished.

Trends in Social Norms Towards Smoking Between 2002 and 2015 Among Daily Smokers: Findings From the International Tobacco Control Four Country Survey (ITC 4C).

OBJECTIVE: To assess trends in daily smokers' social norms and opinions of smoking between 2002 and 2015 in Canada, the United States, the United Kingdom, and Australia. METHOD: Data were from wave 1 (2002) to wave 9 (2013-2015) of the longitudinal International Tobacco Control Four Country Survey (Canada, the United States, the United Kingdom, Australia), involving 23 831 adult daily smokers. Generalized estimating equation logistic regression models, adjusted for demographics and survey design effects, assessed associations of wave and country with outcomes: (A) over half of five closest friends smoke, (B) agreeing that people important to you believe you should not smoke, (C) agreeing that society disapproves of smoking, and (D) negative opinion of smoking. RESULTS: Between 2002 and 2015, adjusting for covariates, (A) over half of five closest friends smoke did not change (56% vs. 55%; adjusted odds ratio [AOR] = 0.95 [95% Confidence Interval = 0.85-1.07]), (B) agreeing that people important to you believe you should not smoke generally decreased (89% vs. 82%; AOR = 0.54 [0.46-0.64]) despite an increase around 2006-2007, (C) agreeing that society disapproves of smoking increased between 2002 and 2006-2007 (83% vs. 87%; AOR = 1.38 [1.24-1.54]) then decreased until 2013-2015 (78%; AOR = 0.74 [0.63-0.88]), and (D) negative opinion of smoking decreased between 2002 and 2010-2011 (54% vs. 49%; AOR = 0.83 [0.75-0.91]) despite an increase around 2005-2006 and at the final wave (2013-2015). Except friend smoking, Canada had the greatest, and the United Kingdom the lowest, antismoking social norms and opinions. CONCLUSIONS: Except friend smoking and opinion of smoking, daily smokers' social norms became less antismoking between 2002 and 2015 despite increases around 2006-2007. Several potential explanations are discussed yet remain undetermined. IMPLICATIONS: Increasingly comprehensive tobacco control policies alongside decreasing smoking prevalence in Canada, the United States, the United Kingdom, and Australia have led to the assumption that smoking has become denormalized in these countries. Absent from the literature is any formal assessment of social norms towards smoking over time. Contrary to our hypotheses, this study found that the injunctive social norms of daily smokers became less antismoking between 2002 and 2015, despite increases around 2006-2007. There was no change over time in the proportion of daily smokers who report that over half of their five closest friends smoke.

Nicotine replacement treatment, e-cigarettes and an online behavioural intervention to reduce relapse in recent ex-smokers: a multinational four-arm RCT.

BACKGROUND: Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic 'emergency' use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions. DESIGN: A randomised controlled trial. SETTING: English stop smoking services and Australian quitlines, Australian social media and St Vincent's Hospital Melbourne, Fitzroy, VIC. PARTICIPANTS: Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited. INTERVENTIONS: Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages (n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages (n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages (n = 58) or (4) usual care plus static text messages (n = 59). OUTCOME MEASURES: Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete. RESULTS: The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively (p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively (p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings. LIMITATIONS: The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention. CONCLUSIONS: Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution. FUTURE WORK: Further studies of both interventions are warranted, using simpler study designs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11111428. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.

Stop smoking services help people to stop smoking over a short period of time. However, nearly three-quarters of quitters return to smoking (i.e. relapse) within 1 year. Effective relapse prevention strategies are needed. Traditional behavioural relapse prevention strategies (e.g. teaching techniques to resist having a cigarette) have not proved effective. However, an earlier study showed that an online programme guiding smokers in stopping smoking and remaining abstinent reduced relapse between 1 week and 6 months. Long-term use of stop smoking medications (e.g. nicotine replacement treatment) can also help, but most successful quitters do not continue to use them. Nicotine mouth spray, lozenges or electronic cigarettes that can quickly help relieve urges to smoke and that ex-smokers can use 'in emergencies' could be a more attractive option. We planned to test these two interventions, on their own and together, in 1400 participants who had quit ≥ 4 weeks previously and who were recruited from English stop smoking services and Australian quitlines. We would then compare these participants with the participants following usual care (i.e. access to stop smoking medications used during the quit attempt for up to 3 months). Owing to delays in study set-up and difficulties in recruiting, the study recruited only 234 participants (n = 131 in Australia and n = 103 in England). We studied participants' reactions to the two interventions and to their combination, and how clinically effective the interventions were. Both interventions were rated positively by most participants. Among the participants in Australia, electronic cigarettes were more popular than medical nicotine products. In England, both products were equally popular. Participants in the online intervention group appreciated the advice on coping strategies, but they rarely completed repeat assessments. In addition, participants who were not in this group used the strategies just as much. There were hints that the interventions may be helpful in preventing relapse. There is an indication that the two interventions combined did not do any better than each on its own, but this requires replication in a larger study. Although the interventions show promise, the small number of participants recruited means that we are unable to make strong conclusions. The study identified areas for future work.

Effects of a Mobile App Called Quittr, Which Utilizes Premium Currency and Games Features, on Improving Engagement With Smoking Cessation Intervention: Pilot Randomized Controlled Trial.

BACKGROUND: Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. OBJECTIVE: The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. METHODS: We designed and developed a smoking cessation app called "Quittr" in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called "Tappy Town," and a premium virtual currency called "QuitCoins." The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. RESULTS: No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, P<.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. CONCLUSIONS: Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&isReview=true.

Higher incentive amounts do not appear to be associated with greater quit rates in financial incentive programmes for smoking cessation.

INTRODUCTION: Financial incentive (FI) programmes can promote smoking cessation. While foundational research suggests higher FI amounts may better produce outcomes, confirmation is needed. Further, the optimal amount(s) needed to cost-effectively promote change is unclear. Our objective was to reconfirm whether higher amounts are associated with greater quitting through review of previous programmes, before assessing whether non-linear trends and obvious inflections in this relationship exist which may highlight optimal amounts. METHODS: Four databases were searched for controlled or randomised controlled studies which detailed FI programmes for smoking cessation in adults. RESULTS: Twenty-six studies were included. Programmes varied in length (3.0-52.0 weeks, median = 12.0), FI provision timing, and longest follow-up (5.5-24.0 months, median = 6.0). The odds ratio of quitting at longest follow-up ranged from 0.32 to 5.89. Maximum FI amounts were between US$106.19 and $4,027.92. Quit rates and amounts were not significantly correlated. Subsequent comparisons to reduce between-study variations were non-significant. Further analyses revealed no evidence of non-linear fits, changes in inflection, or cut-points. CONCLUSIONS: While higher FI amounts were not associated with greater quitting within this review, the limited data available and variations in target populations and programme designs unrelated to the amount have undoubtedly influenced results. Findings suggest information on this relationship and optimal FI amounts are not determinable through current evidence. As this information is important for cost-effectiveness evaluations and real-world viability, further investigation is necessary. Laboratory research could provide valuable initial insight. Trials comparing programme efficacy under the identified amounts could then be implemented.

Socioeconomic differences in the motivation to stop using e-cigarettes and attempts to do so.

INTRODUCTION: In England, the use of electronic cigarettes as a smoking cessation aid has become more popular than any other aid. Previous research suggests that ex-smokers from lower social groups are more likely to use e-cigarettes compared to ex-smokers from more socially advantaged groups. The present study aimed to assess the association between baseline education, income and employment status and (1) baseline motivation to stop using e-cigarettes (2) attempts to stop using e-cigarettes during follow-up among current smokers, recent ex-smokers and long-term ex-smokers who use e-cigarettes. METHODS: UK online longitudinal survey of smokers, ex-smokers and e-cigarette users, May/June 2016 (baseline) and September 2017 (follow-up). In logistic regression models, motivation to stop using e-cigarettes at baseline (n = 994) and attempts to stop using e-cigarettes at follow-up (n = 416) among current smokers and ex-smokers were regressed onto baseline educational attainment, income, employment status while adjusting for baseline demographics, vaping status, smoking and e-cigarette dependence. RESULTS: (1) Respondents with higher education (OR = 1.36; 95% CI: 1.06-1.74) or higher income (OR = 1.52; 95% CI: 1.17-1.98) were more likely to be motivated to stop using e-cigarettes, but only in unadjusted analysis. (2) Again, in unadjusted analysis only, employment was associated with reduced odds of attempting to stop using e-cigarette (OR = 0.50; 95% CI: 0.32-0.79). CONCLUSION: Higher socio-economic status may be associated with higher motivation to stop vaping but with lower likelihood of trying to do so.