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Stuart G Ferguson1,2, Saul Shiffman3,4, Joseph G Gitchell51School of Pharmacy, 2Menzies Research Institute Tasmania, University of Tasmania, Hobart, Australia; 3Pinney Associates, 4University of Pittsburgh, Pittsburgh, PA, USA; 5Pinney Associates, Bethesda, MD, USAAbstract: Nicotine replacement therapy (NRT) has become a central part of the treatment of nicotine dependence. However, NRT’s potential efficacy is limited to some extent by patient adherence and persistence. Here we review the relationship between NRT compliance and adherence, and overall treatment outcome. We then examine the factors that likely impact on treatment compliance and persistence, with a special focus on users’ perceptions of treatment safety and efficacy as possible mediators. Potential clinical strategies for improving suboptimal medication use are also discussed.Keywords: nicotine replacement therapy, compliance, safety

Introduction: Tobacco warning labels typically feature confronting health risk messages which aim to evoke fear to change behaviour. Evidence shows these graphic health warning labels (GHWLs) can be effective but can also lead to unintended responses, including avoidance or defensiveness. Theory suggests that targeting beliefs about the likelihood and benefits of successfully quitting may increase adaptive responses to risk information., Methods: Participants with nil imminent quitting intentions were recruited to a randomised controlled trial (RCT) in the UK investigating the effects of receiving daily textual SMS messages targeting risk, self-efficacy, and response-efficacy beliefs on cessation behaviour. To explore their experiences receiving SMS messages during the RCT as well as their naturalistic exposure to GHWLs, we undertook a qualitative investigation conducting semi-structured interviews with 20 participants. Four main themes were generated via thematic analysis., Results: Participants found efficacy messaging motivating, reporting increased hope for cessation. Further, these messages bolstered knowledge about cessation benefits and treatment options, which may increase treatment-related health literacy. Self-efficacy and response-efficacy messages were well-received and seen to complement each other whereas naturalistic exposure to GHWLs was associated with defensive responses and use of strategies to manage negative affect. GHWLs were seen to contribute to stigmatisation of PWS as part of a broader denormalisation of smoking., Conclusions: GHWLs in their current form can have unintended consequences for people who smoke and can lead to defensive responses. By contrast, messages that address efficacy beliefs can increase hope, knowledge of cessation supports and motivation, thus supporting adaptive responses to smoking health risks., Implications: Continued use of confronting GHWLs in their current form should be reconsidered. Future policy and research should investigate how efficacy content can be effectively integrated into tobacco packaging to optimise the impact of this space in targeting determinants of cessation. Efficacy content can give people who smoke hope for the future and valuable information about pathways to cessation. These benefits may have applications in other streams of health promotion such as primary care, m-health initiatives or public service announcements., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

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., Aims and Methods: Adults who reported currently smoking (n = 367) were randomly assigned to one of four groups: Small text-only 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 2 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 (eg, forgoing/stubbing). Separate mixed-effects logistic models were estimated to evaluate moderation of labeling group contrasts (ie, 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, and 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 < .001). Time discounting moderated insert effects, with inserts promoting forgoing/stubbing only among those with low time discounting (ie, lower impulsivity; OR = 4.35, p < .001)., Conclusions: Inserts with efficacy messages appear effective mostly among people with low time discounting, whereas PHWLs appear most effective among 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 (ie, forgoing or stubbing out cigarettes) among those with low-time discounting (ie, low impulsivity). Alternative interventions may be needed for people with high-time discounting, as found in cessation trials. 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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

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., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors declare that they have no competing interests, financial or otherwise, related to the current work. All the authors report that since the initial planning of the work, this study was supported by the National Cancer Institute of the National Institutes of Health. J.W. Hardin reports that in the past 36 months participated on scientific review board of Celgene (Bristol Myers Squibb), which is unrelated to this manuscript. E.E. Hackworth reports that in the past 36 months received support for attending meetings and travelling from the National Institute on Drug Abuse, Society for the Study of Addiction, University of South Carolina. J.F. Thrasher reports that in the past 36 months there were grants or contracts from the UK Medical Research Council, the University of South Carolina, the Food & Drug Administration/NIH, the Canadian Institutes of Health Research, the Australian National Health and Medical Research Council and the American Cancer Society. In the past 36 months, he has also received consulting fees from the University of Stirling and has received payments for lectures/ presentations from the University of Alabama. He has also participated on the University of South Carolina Board for NIH for a funded clinical trial. Finally, J.F. Thrasher reports that in the past 36 months participated in the “Smokefree South Carolina” and the Tobacco Product Scientific Advisory Committee of the US Food and Drug Administration. J. Niederdeppe reports that in the past 36 months there were grants or contracts from the Agency for Research on Healthcare Quality (Grant to Cornell), Robert Wood Johnson Foundation (Multiple Grants to Cornell), National Institute of Diabetes and Digestive and Kidney Diseases (Grant to Cornell) and the National Science Foundation (Grant to Cornell). In the past 36 months, he has also received Payment for service on academic panel during Policy Dissemination Science workshop from New York University, Honorarium for public lecture and keynote speech + travel reimbursement from Peking University, a small payment (which is standard) for service on several grant review panels from NIH Office of the Director. He also reports that he has travelled for several workshops and consensus committee report meetings paid for by the National Academies (no honoraria or consulting fee is part of this work) from the National Academy of Medicine, and has travelled to Monterrey for a 2-day meeting to inform public health investments for the Hayward Institute (received small honorarium as well) from the Hayward Institute. In the past 36 months, he has offered service on center grant EAB, including consulting payment and travel to one meeting/year from the University of North Carolina, and has offered service on center grant EAB, including consulting payment and travel to one meeting/year from the University of Wake Forest. Finally, J. Niederdeppe reports that in the past 36 months he had an unpaid role on BOD for local non-profit that provides mental health and wellness services from Family & Childrens Service of Ithaca. M. Kim reports that in the past 36 months there were grants or contracts from the National Institute of Drug Abuse and the Food and Drug Administration., (© 2024 Lambert V.C. et al.)

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., (© The Author(s) 2024. Published by Oxford University Press.)

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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., (© Society of Behavioral Medicine 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: To control infections, behavioral non-pharmaceutical interventions (NPIs) such as social distancing and hygiene measures (masking, hand hygiene) were implemented widely during the COVID-19 pandemic. At the same time, adherence to NPIs has also been implied in an increase in mental health problems. However, the designs of many existing studies are often poorly suited to disentangle complex relationships between NPI adherence, mental health symptoms, and health-related cognitions (risk perceptions, control beliefs)., Purpose: To separate between- and temporal within-person associations between mental health, health-related cognitions, and NPI adherence., Methods: Six-month ecological momentary assessment (EMA) study with six 4-day assessment bouts in 397 German adults. Daily measurement of adherence, mental health symptoms, and cognitions during bouts. We used dynamic temporal network analysis to estimate between-person, as well as contemporaneous and lagged within-person effects for distancing and hygiene NPIs., Results: Distinct network clusters of mental health, health cognitions, and adherence emerged. Participants with higher control beliefs and higher susceptibility were also more adherent (between-person perspective). Within-person, similar findings emerged, additionally, distancing and loneliness were associated. Lagged findings suggest that better adherence to NPIs was associated with better mental health on subsequent days, whereas higher loneliness was associated with better subsequent hygiene adherence., Conclusions: Findings suggest no negative impact of NPI adherence on mental health or vice versa, but instead suggest that adherence might improve mental health symptoms. Control beliefs and risk perceptions are important covariates of adherence-both on between-person and within-person level., (© Society of Behavioral Medicine 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Adhering to behavioral recommendations and nonpharmaceutical interventions (NPIs) is a key to control COVID-19 infection rates. However, rates have decreased globally, and potentially modifiable determinants of ongoing adherence and their interaction with social and physical momentary environments are still poorly understood. Here, we comprehensively examine within-person variations and between-person differences in known behavioral determinants (capability and motivation), as well as the moderating role of situational variable environmental factors (opportunity) in predicting adherence to hygiene and social distancing behaviors., Method: Ecological momentary assessment study over 6 months with monthly assessment bouts (4 days each and five daily assessments) in 623 German adults. Repeated daily assessments of capability, opportunity, motivation, and behavior (COM-B) model factors. Bayesian multilevel logistic regression models were estimated to examine main effects of COM-B factors and moderating effects of momentary environmental factors., Results: Momentary adherence to NPIs was predicted by within-person changes in COM-B factors (motivation: intentions, goal conflict, and control beliefs; opportunities: regulations and norms). Between-person differences in capabilities (habit strength) and motivation (intentions and control beliefs) predicted adherence across situations. Situation-specific environmental factors moderated the motivation-behavior association (regulation measures increased; goal conflict and nonadherent others decreased the association)., Conclusions: Individual momentary (within-person) and stable (between-person) motivation indicators predicted adherence. However, situational environmental factors such as regulations or norms have strong main effects and moderate the motivation-behavior translation. These findings have policy implications, supporting recent claims to not rely on the narrative of "personal responsibility," but instead combine health education measures to increase individual motivation with consistent regulation. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

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., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Attentional bias towards food related stimuli has been proposed as a potential target for dieting intervention, however the evidence supporting a relationship between attentional bias and food intake is mixed. Theory holds that food related attentional bias should be positively associated with measures of stimulus-controlled eating, and that implicit processes such as impulsivity moderate this association. The aim of the present study was to examine whether the proposed relationship between food-related attentional bias and stimulus control exists, and whether it is moderated by impulsivity., Method: A community sample of 68 participants completed a food-related attentional bias task and impulsiveness scale during a laboratory visit, after which they recorded their real-world eating in real-time over 14 days using Ecological Momentary Assessment (EMA). During this time, participants also responded to 4-5 randomly timed assessments per day. Food outlet presence (e.g., fast food restaurants, cafes, corner stores etc.) was assessed during both eating and non-eating assessments. EMA data was then used to determine levels of stimulus controlled eating for each participant., Findings: Substantial variation was seen in both our measure of both food-related attentional bias (Range: 33.9 to 80.0) and in the degree to which the participant's eating could be categorised as being under stimulus control (Range: 0.50 to 0.93). However, food-related attentional bias scores were not a significant independent predictor of stimulus control and nor was this relationship moderated by impulsivity., Conclusion: Contrary to theoretical predictions, we found no evidence that of an association between attentional bias, impulsivity, and stimulus control. More work is needed to better understand the implicit processes underlying eating behaviour in the real-world., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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, M age 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).

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

Influential psychological theories hypothesize that people consume alcohol in response to the experience of both negative and positive emotions. Despite two decades of daily diary and ecological momentary assessment research, it remains unclear whether people consume more alcohol on days they experience higher negative and positive affect in everyday life. In this preregistered meta-analysis, we synthesized the evidence for these daily associations between affect and alcohol use. We included individual participant data from 69 studies ( N = 12,394), which used daily and momentary surveys to assess affect and the number of alcoholic drinks consumed. Results indicate that people are not more likely to drink on days they experience high negative affect, but are more likely to drink and drink heavily on days high in positive affect. People self-reporting a motivational tendency to drink-to-cope and drink-to-enhance consumed more alcohol, but not on days they experienced higher negative and positive affect. Results were robust across different operationalizations of affect, study designs, study populations, and individual characteristics. These findings challenge the long-held belief that people drink more alcohol following increases in negative affect. Integrating these findings under different theoretical models and limitations of this field of research, we collectively propose an agenda for future research to explore open questions surrounding affect and alcohol use., Competing Interests: Competing interests: Authors declare that they have no competing interests.

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., (© 2022 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

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).

Background: The possibility of residual impairment of cognitive performance after multiday drinking sessions is particularly important given the potential for the deleterious effects of fatigue and hangover. This pilot study aimed to devise a methodology to compare sober performance on driving-relevant attentional tasks at the end of a 4-day music festival with performance at varying levels of the breath-alcohol curve., Methods: Fifty-two participants completed selective and sustained attention tasks at a breath alcohol concentration (BrAC) of 0.00%, 0.05%, and 0.08% following acute dosing in a controlled laboratory setting. A subset of participants (n = 13) were then tested at the conclusion of a 4-day music festival at 0.00% BrAC, with task performance compared with laboratory results., Results: During the laboratory phase, sustained attention was poorer at the 0.05% ascending timepoint only (compared to 0.00% BrAC). During the festival phase, participants made a greater number of errors on the selective attention task predeparture than at 0.00% and 0.05% BrAC in the laboratory. Sustained attention performance was poorer while intoxicated in the laboratory., Conclusions: Our findings suggest that the absence of blood alcohol acutely may not be indicative of unimpaired cognitive performance and that other factors related to multiday drinking may produce driving-related attentional deficits. The findings reinforce the need to measure attentional performance in real-world drinking contexts despite the methodological complexities of doing so. A larger study is warranted to replicate the findings and should include attentional measures that either are more sensitive to the effects of acute alcohol intoxication than those in our study or are based on a driving simulator., (© 2022 The Authors. Alcoholism: Clinical & Experimental Research published by Wiley Periodicals LLC on behalf of Research Society on Alcoholism.)

Introduction and Aims: Comprehensively investigating alcohol-related behaviours in the context of a dynamic multi-day alcohol-licensed event is important for understanding and minimising patron risk. We aimed to assess the measurement utility of implementing a multi-dimensional alcohol assessment battery using biometric data collection, real-time drink logs and retrospective self-report measures over the course of a 4-day music festival., Methods: Fourteen adults participated (n = 7 male, mean age 21.9 years). Breath and transdermal alcohol concentration (BrAC and TAC, respectively) were measured using breathalysers and transdermal alcohol bracelets. A real-time drink log was completed via smartphones on initiating each drink, and a retrospective questionnaire was administered up to twice daily throughout the event (6 timepoints total)., Results: While almost all participants (92.9%) logged significantly fewer drinks in real-time than they retrospectively reported via the twice-daily questionnaires, logs provided important contextual information including the types of drinks consumed and drinking intensity. Compared to BrAC, TAC provided a better understanding of the time course of intoxication, indicating highest alcohol consumption outside of static BrAC assessment windows. However, BrAC provided a better assessment of present state: all participants were 0.00% BrAC at departure despite over two-fifths (42.9%) of the sample's last TAC reading exceeding 0.00%., Conclusions: As standalone assessments, each method possessed limitations. As a combined battery, they were successfully administered simultaneously, resulting in a more comprehensive overview of alcohol consumption/intoxication over the prolonged drinking session. However, the marked burden of simultaneous administration should be considered, and measures should be chosen judiciously based on research needs., (© 2020 Australasian Professional Society on Alcohol and other Drugs.)

Objective: Food-related attentional bias has been defined as the tendency to give preferential attention to food-related stimuli. Attentional bias is of interest as studies have found that increased attentional bias is associated with obesity; others, however, have not. A possible reason for mixed results may be that there is no agreed upon measure of attentional bias: studies differ in both measurement and scoring of attentional bias. Additionally, little is known about the stability of attentional bias over time. The present study aims to compare attentional bias measures generated from commonly used attentional bias tasks and scoring protocols, and to test re-test reliability. Methods: As part of a larger study, 69 participants (67% female) completed two food-related visual probe tasks at baseline: lexical (words as stimuli), and pictorial (pictures as stimuli). Reaction time bias scores (attentional bias scores) for each task were calculated in three different ways: by subtracting the reaction times for the trials where probes replaced (1) neutral stimuli from the trials where the probes replaced all food stimuli, (2) neutral stimuli from the trials where probes replaced high caloric food stimuli, and (3) neutral stimuli from low caloric food stimuli. This resulted in three separate attentional bias scores for each task. These reaction time results were then correlated. The pictorial visual probe task was administered a second time 14-days later to assess test-retest reliability. Results: Regardless of the scoring use, lexical attentional bias scores were minimal, suggesting minimal attentional bias. Pictorial task attentional bias scores were larger, suggesting greater attentional bias. The correlation between the various scores was relatively small ( r = 0.13-0.20). Similarly, test-retest reliability for the pictorial task was poor regardless of how the test was scored ( r = 0.20-0.41). Conclusion: These results suggest that at least some of the variation in findings across attentional bias studies could be due to differences in the way that attentional bias is measured. Future research may benefit from either combining eye-tracking measurements in addition to reaction times., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Franja, McCrae, Jahnel, Gearhardt and Ferguson.)

Objective: 'Comfort eating' has been used to explain real-world food choices, suggesting that individuals are drawn to energy-dense ('unhealthy') snacks when experiencing negative affect. However, this concept has rarely been studied, particularly in real-world settings. Similarly, the effects of snacking on subsequent affect are also poorly understood. The present study aimed to examine the association between affect and snacking in daily life., Methods: One hundred and forty-one adults recorded their food intake in real time for ~14 days using a study issued mobile phone. Participants also responded to randomly timed assessments. During both types of assessments, participants indicated their current level of affect. By anchoring off snacking events, the trajectory of affect in the hours leading up to - and following - snacking was explored., Results: In the three hours leading up to a healthy snack, affect was stable. In contrast, affect fell during the hours leading up to an unhealthy snack. The interaction between snack type and time was significant. A similar, but opposite, pattern was seen following snacking: where affect decreased after unhealthy snacking, affect increased following healthy snack intake., Conclusion: The findings are consistent with the hypothesis of comfort eating, with unhealthy snacking being preceded by worsening affect. Unhealthy snacking did not, however, lead to affect improvements afterwards, which questions the 'effectiveness' of comfort eating. The intake of healthy snacks however was associated with positive affective experiences. These findings could function as a component of interventions aiming at improving dietary behaviours., (© 2021 The British Psychological Society.)

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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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.

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., (© 2021 National Rural Health Alliance Ltd.)

Adrenal glucocorticoid secretion into the systematic circulation is characterised by a complex rhythm, composed of the diurnal variation, formed by changes in pulse amplitude of an underlying ultradian rhythm of short duration hormonal pulses. To elucidate the potential neurobiological significance of glucocorticoid pulsatility in man, we have conducted a randomised, double-blind, placebo-controlled, three-way crossover clinical trial on 15 healthy volunteers, investigating the impact of different glucocorticoid rhythms on measures of mood and neural activity under resting conditions by recruiting functional neuroimaging, computerised behavioural tests and ecological momentary assessments. Endogenous glucocorticoid biosynthesis was pharmacologically suppressed, and plasma levels of corticosteroid restored by hydrocortisone replacement in three different regimes, either mimicking the normal ultradian and circadian profile of the hormone, or retaining the normal circadian but abolishing the ultradian rhythm of the hormone, or by our current best oral replacement regime which results in a suboptimal circadian and ultradian rhythm. Our results indicate that changes in the temporal mode of glucocorticoid replacement impact (i) the morning levels of self-perceived vigour, fatigue and concentration, (ii) the diurnal pattern of mood variation, (iii) the within-network functional connectivity of various large-scale resting state networks of the human brain, (iv) the functional connectivity of the default-mode, salience and executive control networks with glucocorticoid-sensitive nodes of the corticolimbic system, and (v) the functional relationship between mood variation and underlying neural networks. The findings indicate that the pattern of the ultradian glucocorticoid rhythm could affect cognitive psychophysiology under non-stressful conditions and opens new pathways for our understanding on the neuropsychological effects of cortisol pulsatility with relevance to the goal of optimising glucocorticoid replacement strategies., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

Background: Many discretionary foods ("snacks") contribute both to individual health risks and to global issues, in particular through high carbon footprints and water scarcity. Snacking is influenced by the presence of snacking cues such as food availability, observing others eating, and negative affect. However, less is known about the mechanisms underlying the effects of negative affect. This study examines whether the individual odds of consuming high-calorie snacks as a consequence to being exposed to known snacking cues were moderated by experiencing (i) higher or lower total negative affect per day or (ii) higher or lower negative affect variability per day., Methods: Secondary analysis of an ecological momentary assessment study of 60 participants over 14 days with food logs and randomly timed assessments of known snacking cues. High total daily negative affect levels (daily within-participant means) and negative affect variability (daily within-participant SDs) were examined as moderators to predict high-calorie snacking in three-level hierarchical random effects logistic regressions., Results: Consistent with previous studies, the odds of snacking increased when food was available (OR = 5.05, 95% CI 3.32, 7.66), when others were eating (OR = 5.11, 95% CI = 3.73, 6.99), and when participants experienced more negative affect (OR = 1.02, 95% CI = 1.01, 1.03). Associations for food availability (OR = 0.92, 95% CI 0.86, 0.99) and others eating (OR = 0.95, 95% CI 0.91, 0.99) were significantly moderated by negative affect variability such that associations between cues and high-calorie snacking were weaker on days with higher negative affect variability, but not negative affect levels., Conclusion: The relationship between cues to high-calorie snacking and snacking behavior varies with variability in negative affect, suggesting a complex relationship between affect and high-calorie snacking. Clearer conceptualizations on the relation between affect and eating are needed., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Papadakis, Ferguson and Schüz.)

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., Competing Interests: Competing interests: SGF has consulted for various pharmaceutical companies on matters relating to smoking cessation. All other authors declare no conflicts of interest., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (©Ivan Bindoff, Tristan R Ling, Peter Gee, Benjamin Geelan, Stuart G Ferguson, Gregory M Peterson. Originally published in JMIR Serious Games (http://games.jmir.org), 14.12.2020.)

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.

Background: Evidence suggests decisions about when, what, and how much to eat can be influenced by external (location, food outlet presence, food availability) and internal (affect) cues. Although the relationship between stimulus control and obesity is debated, it is suggested that individuals with higher BMIs are more driven by cues to eating than individuals in the healthy-weight range (HWR). This study investigates the influence of stimulus control on real-world food intake, and whether stimulus control differs by BMI. It was hypothesised that, compared to those in the HWR, eating among individuals with higher BMIs would be under greater stimulus control., Method: 74 participants (n = 34 BMI < 24.9, n = 40 BMI > 24.9) recorded food intake for 14 days using Ecological Momentary Assessment. Participants also responded to 4-5 randomly-timed assessments per day. Known external and internal eating cues were assessed during both assessment types. Within-person logistic regression analyses were used to predict eating vs. non-eating occasions from stimulus control domains., Findings: Results support the hypothesis that eating was influenced by stimulus control: food availability, affect, time of day, and location significantly distinguished between eating and non-eating instances (AUC-ROC = 0.56-0.69, all p's < 0.001). The presence of food outlets was significantly better at distinguishing between eating and non-eating instances for those with higher BMIs (compared to individuals in the HWR)., Discussion: Results support the notion of stimulus control in shaping eating decisions. Differences in levels of stimulus control between participants in the HWR compared to those with a high BMI suggest that dietary improvement interventions may be more effective when they are tailored to the individual and consider environmental influences on eating behaviour., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background and Aims: Non-daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non-daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations., Design: Within a 6-week randomized, placebo-controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used., Setting: Smoking cessation research clinic in Pittsburgh, PA, USA., Participants: A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation., Intervention: Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as-needed dosing instructions., Measurements: Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable., Findings: Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22-0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78-3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06)., Conclusions: When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non-daily smokers., (© 2020 Society for the Study of Addiction.)

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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Ferguson has worked as a consultant to GlaxoSmithKline Consumer Healthcare and Chrono Therapeutics on matters relating to smoking cessation, has received researcher-initiated project grant funding from Pfizer (through the GRAND initiative), and has served on an advisory board for Johnson & Johnson. These organizations were not involved in the current study in any way. Ms. Breen and Dr. Palmer have no conflicts to declare., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Rationale: Little is known about relapse among non-daily, intermittent smokers (ITS), who have difficulty quitting, despite a lack of dependence., Objectives: To analyze situations associated with temptations to smoke and smoking lapses among ITS trying to maintain abstinence., Methods: Participants were 130 initially abstinent ITS in the placebo arm of a smoking cessation study. EMA data captured participants' situations and states in temptations (n = 976), including those that eventuated in lapses (n = 147), for up to 6 weeks. Randomly timed assessments assessed background states (n = 11,446). Participants also reported coping performed to prevent lapses. Multilevel analyses compared temptations to background situations, and lapse episodes to resolved temptations., Results: Temptations were marked by exposure to smoking cues, including others smoking, lax smoking restrictions, and alcohol consumption, as well as more negative affect. Lapses did not differ from resolved temptations in craving intensity, but were more often associated with smoking cues and availability of cigarettes, alcohol consumption, and worse affect, and were more often attributed to good moods. Both behavioral and cognitive coping responses were associated with avoiding lapsing, but behavioral coping had much larger effects. The effects of affective distress on lapse risk were mediated by its effects on coping., Conclusions: Smoking cues play a major role in ITS' temptations and lapses, perhaps indicating a degree of behavioral dependence. Affective distress also played a role in ITS lapses, undermining the idea that the affective distress seen in daily smokers' lapses is due to nicotine withdrawal. The data reinforce the important role of coping in preventing lapses.

Background: It has been observed that eating is influenced by the presence and availability of food. Being aware of the presence of food in the environment may enable mobile health (mHealth) apps to use geofencing techniques to determine the most appropriate time to proactively deliver interventions. To date, however, studies on eating typically rely on self-reports of environmental contexts, which may not be accurate or feasible for issuing mHealth interventions., Objective: This study aimed to compare the subjective and geographic information system (GIS) assessments of the momentary food environment to explore the feasibility of using GIS data to predict eating behavior and inform geofenced interventions., Methods: In total, 72 participants recorded their food intake in real-time for 14 days using an ecological momentary assessment approach. Participants logged their food intake and responded to approximately 5 randomly timed assessments each day. During each assessment, the participants reported the number and type of food outlets nearby. Their electronic diaries simultaneously recorded their GPS coordinates. The GPS data were later overlaid with a GIS map of food outlets to produce an objective count of the number of food outlets within 50 m of the participant., Results: Correlations between self-reported and GIS counts of food outlets within 50 m were only of a small size (r=0.17; P<.001). Logistic regression analyses revealed that the GIS count significantly predicted eating similar to the self-reported counts (area under the curve for the receiver operating characteristic curve [AUC-ROC] self-report=0.53, SE 0.00 versus AUC-ROC 50 m GIS=0.53, SE 0.00; P=.41). However, there was a significant difference between the GIS-derived and self-reported counts of food outlets and the self-reported type of food outlets (AUC-ROC self-reported outlet type=0.56, SE 0.01; P<.001)., Conclusions: The subjective food environment appears to predict eating better than objectively measured food environments via GIS. mHealth apps may need to consider the type of food outlets rather than the raw number of outlets in an individual's environment., (©Katherine G Elliston, Benjamin Schüz, Tim Albion, Stuart G Ferguson. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 22.07.2020.)

Objectives: To examine dieting goals within a system of individual goals, and the patterns by personally-relevant goals might interfere or facilitate each other. Design: 94 dieters completed an assessment of goals using Little's personal project analysis. Participants identified 7 goals; one of which was pre-defined as adhering to diet. Over the beginning 14 days of their diet, participants completed an Ecological Momentary Assessment study recording their food intake in real-time. Every evening, participants reported their goal engagement and which goals conflicted or facilitated with each other. Main outcome measures/results: Over the study duration, 1452 days of food intake and goal conflict/facilitation were recorded. Participants completed an average of 1.54 ( SD  = 0.85) snacks, an average of 0.94 ( SD  = 1.81) goal conflicts, and 4.16 ( SD  = 4.70) goal facilitations per day. Inter-goal conflict was associated with a significant but small improvement on individuals' mood, but was not associated with daily dietary intake or long-term weight-loss. Similarly, inter-goal facilitation was not associated with daily dietary intake or long-term weight-loss. Daily food intake was a significant predictor of long-term weight-loss. Conclusions: The results of this study suggest the impact of inter-goal conflict and facilitation on dieting is not via overall snack or food consumption.

Introduction: Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit., Methods: ITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects., Results: Nicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time., Conclusions: Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence., Implications: Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

Objectives Health behaviour theories outline how cognitions predict behaviours, but rarely specify the temporal relation between cognitions and behaviours. It is not known whether these predictive relationships vary depending on temporal resolution or whether the relative influence of cognitions varies with measurement schedules. The current exploratory study therefore investigates whether the associations between behavioural cognitions (self-efficacy, intention, and risk perception) and smoking vary when measured momentarily, at day level, or using the more common baseline-follow-up design. Design EMA study involving 36 continuing smokers over 17 days. Participants logged cigarettes and reported their cognitions at baseline, daily (evening), and in response to momentary surveys. Methods Random-effects models were used to compare the effects of cognitions measured at different time points on (1) the number of cigarettes smoked daily and (2) the time interval until the next cigarette smoked. Results Self-efficacy and risk perception measured at baseline significantly predicted cigarettes smoked each day, but this effect became non-significant when daily measurements of cognitions were included in the model. Momentary smoking behaviour was predicted by momentary measurements of risk perception, with no significant effects of social cognitions at baseline. Conclusions Relationships between cognitions and behaviours vary according to the temporal resolution of the measurement schedule. Ensuring that the temporal resolution of assessment is appropriate for the temporal dynamics of the behaviour being assessed is important. Future research is needed to investigate the potential for leveraging specific cognitive processes depending on temporal importance in order to increase health-promoting behaviours. Statement of contribution What is already known on this subject? Social cognitions including intentions, risk perception, and self-efficacy have been observed to predict smoking. Little is known about the role of time in the cognition-behaviour relationship. Cognitions have been observed to fluctuate, but instability is typically not considered in research design. What does this study add? Daily measurement of social cognitions predicts behaviour better than measurements taken at baseline. Momentary smoking behaviour is predicted by momentary cognitions at the intra-individual level. Temporal resolution of measurement should be considered when investigating cognition-behaviour relationships., (© 2019 The British Psychological Society.)

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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2020 The Authors.)

Introduction: Given the low efficacy of smoking cessation methods, an experimental medicine model indicating smoking abstinence would be of great benefit to the development of new treatments. Hence the sensitivity of cognitive tasks and ambulatory craving measures to smoking abstinence were investigated., Methods: Cognitive tasks and ambulatory ratings of craving were assessed for sensitivity to acute abstinence (experiment 1), and nicotine replacement therapy administration (NRT) (experiment 2)., Results: In experiment 1 go/no-go performance was improved (Mean Difference [MD] -0.99, 95% CI: -1.90 to -0.08) and craving was lower (Regression Coefficient [RC] -33.39, 95% CI: -39.96 to -26.82) in satiated compared with abstinent smokers. There was no clear evidence that N-back (MD 0.64, 95% CI: -0.42 to 2.51), delay discounting (MD 0.01, 95% CI: 0.001 to 0.005) or dot probe performance (MD 0.61, 95% CI: -0.87 to 1.54) were sensitive to acute abstinence. In experiment 2 go/no-go performance was improved (MD 1.12, 95% CI: 0.16-2.08) and craving was lower (RC -18.59, 95% CI: -24.63 to -12.55) smokers abstinent overnight receiving NRT compared with placebo. There was no clear evidence that N-back (MD -0.25, 95% CI: -1.45 to 0.94), delay discounting (MD 0.01, 95% CI: -0.002 to 0.004) or dot probe performance (MD -0.49, 95% CI: -1.61 to -0.64) were sensitive to NRT., Conclusions: Findings from two experiments converge to suggest that abstinence in smokers reliably increases ambulatory craving assessments and, to a lesser extent, decreases go/no-go task performance. These findings can be utilized in the development of an experimental medicine model to test novel treatments for smoking cessation., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Research methods are needed that can predict whether the availability of potential modified risk tobacco products (MRTPs) may influence smokers' quit-related motivation, choice, and behavior. This pilot study assessed the primary outcomes of feasibility and adherence to address this need using an electronic cigarette (ECIG) as a model MRTP. Cigarette smokers were randomly assigned to use only their own brand of cigarettes (OB-only) or a second-generation ECIG (18 ng/ml nicotine) plus their OB cigarettes (ECIG+OB) ad libitum for four weeks. Participants logged products using a mobile device, collected used cigarette filters, and provided saliva samples every day for analysis of cotinine. They returned to the lab once per week to provide a breath sample and accept or decline a choice to quit all tobacco products (i.e., cigarettes and/or ECIGs). They also returned for a one-month follow-up visit. Of those participants randomized (n = 60), 56.7% completed the 4-week intervention and 40.0% completed the follow-up visit. The primary reason for withdrawal was poor adherence with mobile device use. Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks. With protocol modifications to reduce participation burden, the current method might ultimately be used by regulators to predict how smokers' quit-related motivation, choice, and behavior are influenced by current and future MRTPs., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

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

Background and Aims: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline., Design: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment., Setting: Australian population-based study., Participants: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services., Intervention and Comparator: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions)., Measurements: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview., Comments: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide., (© 2018 Society for the Study of Addiction.)