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Calves with lower concentrations of immunoglobulin G (IgG) in their blood, have a greater risk of developing diseases. There is a lack of knowledge on genetic markers known to be associated with immunological variability or disease resistance. Therefore, the objective of this study was to identify SNP markers associated with passive immunity measures (serum IgG, serum protein, albumin, globulin and total protein concentrations, total solids Brix percentage, zinc sulphate turbidity units) and disease (pneumonia, diarrhoea, crude illness) traits in Irish commercial beef-suckler and dairy calves through genome wide association studies (GWAS). Genotyping was performed on DNA samples from beef-suckler (n = 698) and dairy (n = 1178) calves, using the IDBv3 chip. Heritability of passive immunity associated traits (range 0.02–0.22) and the disease traits (range 0.03–0.20) were low-to-moderate. Twenty-five and fifteen SNPs approached genome wide significance (P −5) for the passive immunity and the disease traits, respectively. One SNP “ARS-BFGL-BAC-27914” reached Bonferroni genome wide significance (P −6) for an association with serum IgG concentration in beef calves. Further work will evaluate these SNPs in larger cattle populations and assess their contribution to genomic selection breeding strategies, aimed towards producing more disease resistant livestock.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. Implications This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Introduction Affective disorders and symptoms (ADS) are predictive of lower odds of quitting smoking. However, it is unknown which approach to assessing ADS best predicts cessation. This study compared a battery of ADS screening instruments with a single, self-report question on predicting cessation. Among those who self-reported ADS, we also examined if an additional question regarding whether participants believed the condition(s) might interfere with their ability to quit added predictive utility to the single-item question. Methods Participants (N = 2637) enrolled in a randomized controlled trial of web-based smoking treatments completed a battery of five ADS screening instruments and answered a single-item question about having ADS. Those with a positive self-report on the single-item question were also asked about their interference beliefs. The primary outcome was complete-case, self-reported 30-day point prevalence abstinence at 12 months. Results Both assessment approaches significantly predicted cessation. Screening positive for ≥ one ADS in the battery was associated with 23% lower odds of quitting than not screening positive for any (p = .023); those with a positive self-report on the single-item had 39% lower odds of quitting than self-reporting no mental health conditions (p < .001). Area under the receiver operating characteristic curve values for the two assessment approaches were similar (p = .136). Adding the interference belief question to the single-item assessment significantly increased the area under the receiver operating characteristic curve value (p = .042). Conclusions The single-item question assessing ADS had as much predictive validity, and possibly more, than the battery of screening instruments for identifying participants at risk for failing to quit smoking. Adding a question about interference beliefs significantly increased the predictive utility of the single-item question. Implications This is the first study to demonstrate that a single-item question assessing ADS has at least as much predictive validity, and possibly more, than a battery of validated screening instruments for identifying smokers at highest risk for cessation failure. This study also demonstrates adding a question about interference beliefs significantly adds to the predictive utility of a single, self-report question about mental health conditions. Findings from this study can be used to inform decisions regarding how to assess ADS in the context of tobacco treatment settings.

Smoking rates are disproportionately high among people living with HIV. Smokers living with HIV (SLWH) are also largely unaware of the HIV-specific deleterious effects of smoking and often lack motivation and confidence in their ability to quit tobacco. To address these issues, we developed the Wellness Intervention for Smokers Living with HIV (WISH). WISH is grounded in the Information-Motivation-Behavioral Skills (IMB) Model and is designed for all SLWH, regardless of their initial motivation to quit. It follows evidence-based, best practice guidelines for nicotine dependence treatment, but is innovative in its use of a comprehensive wellness approach that addresses smoking within the context of HIV self-management including treatment adherence and engagement, stress management, substance use, and other personally relevant health behavior goals. The described randomized trial will enroll SLWH who are receiving care at Veterans Affairs (VA) medical centers and compare WISH's impact on smoking behavior to standard care services offered through the National VA Quitline and SmokefreeVET texting program. It will also assess intervention impact on markers of immune status and mortality risk. If effective, WISH could be disseminated to Veterans nationwide and could serve as a model for designing quitline interventions for other smokers who are ambivalent about quitting. The current paper outlines the rationale and methodology of the WISH trial, one of a series of studies recently funded by the National Cancer Institute to advance understanding of how to better promote smoking cessation among SLWH.

Background Dual use of tobacco and cannabis is increasingly common, but it is unclear how it impacts individuals’ interest in or ability to stop smoking. If dual users fail to engage in treatment or have worse treatment outcomes, it would suggest that tobacco treatment programs may need to be tailored to the specific needs of those using cannabis and tobacco. Methods We conducted an observational study using electronic treatment records from adults (18 years and older) who (a) were enrolled in a regional healthcare system in Washington state, (b) sought tobacco cessation treatment through an insurance-covered quitline from July 2016 to December 2018 and (c) had cannabis use frequency during the period of their quitline enrollment documented in their electronic health record (EHR) ( n = 1,390). Treatment engagement was defined by the total number of quitline counseling calls and web-logins completed. Point prevalent self-reported tobacco abstinence was assessed 6 months post-quitline enrollment. Results Thirty-two percent of participants ( n = 441) reported dual use of tobacco and any cannabis during the observation period; 9.4% ( n = 130) reported daily cannabis use. Among dual users reporting daily cannabis use, 13.9% had a diagnosed cannabis user disorder in the EHR. Neither engagement with quitline counseling nor long-term tobacco abstinence rates differed between those using tobacco-only and either dual-use group (i.e., persons using any cannabis or daily cannabis). Conclusions Dual use of tobacco and cannabis is common among smokers seen in primary care and those enrolling in quitline care, but it may not undermine tobacco quitline engagement or smoking cessation. Opportunities exist in the US to leverage quitlines to identify and intervene with dual users of tobacco and cannabis. HIGHLIGHTS • Tobacco quitline care was equally engaging and effective among tobacco users and dual users of tobacco and cannabis • Many daily cannabis users calling tobacco quitlines likely have a cannabis use disorder • Tobacco quitlines can be leveraged to identify and intervene with dual users of tobacco and cannabis

Background The majority of cigarette smokers want to quit someday but are not ready to commit to long-term abstinence. However, available smoking cessation treatments are not well-suited to meet the needs of these ambivalent smokers. Low-cost, high-reach mobile health (mHealth) interventions may be a cost-efficient means of offering assistance to ambivalent smokers, yet there are currently no evidence-based options available for this group. Objective The aim of this study was to develop and preliminarily evaluate the core content for an mHealth program targeting adult smokers who are ambivalent about quitting. The core content consisted of a series of “personal experiments” similar to those tested as part of a counseling intervention in prior work, including brief cognitive or behavioral tasks designed to boost readiness for changing smoking behavior. Methods We conducted individual user interviews (N=3) to refine program content, and then conducted a one-arm pilot study (N=25) to assess user receptivity and the potential impact of the experiments on motivation and self-efficacy to quit or reduce smoking. Results In user interviews, participants liked the concept of the personal experiments. Participants in the pilot study found a medium-fidelity prototype to be highly acceptable. After watching a brief orientation video that explained how the program works, most participants (80%, 20/25) indicated that it sounded interesting, primarily because it did not require any commitment to quit. All participants (100%, 25/25) completed all 7 experiments, including a 24-hour quit attempt, although not all were able to refrain from smoking for a full day based on qualitative feedback on the experiment. The mean rating of usefulness of the overall program was 4.12 (SD 1.09) out of 5, and the average rating of the difficulty of the experiments was 2.16 (SD 1.18) out of 5. At the last assessment point, 92% (23/25) of the participants indicated that they were more interested in either quitting or cutting back than when they began the program, and 72% (18/25) said that if the program had included a free trial of nicotine replacement therapy, they would have used it to try to quit smoking. Conclusions This formative work confirmed that ambivalent smokers are willing to use and will remain engaged with an mHealth intervention that employs the novel concept of personal experiments to enhance their motivation for and ability to quit smoking. The addition of action-oriented treatment (self-help and free nicotine replacement therapy, quitline referral) could further support users’ efforts to stop smoking and remain quit.

Objectives. To assess the effects of a novel oral health promotion program (Oral Health 4 Life; OH4L) delivered through state-funded tobacco quitlines. Methods. Using a semipragmatic design to balance experimental control and generalizability, we randomized US quitline callers (n = 718) to standard care or standard care plus OH4L. We followed participants for 6 months to assess effects on professional dental care and smoking abstinence. We collected data between 2015 and 2017. Results. Participants were racially diverse (42% non-White) and socioeconomically disadvantaged. Most (71%) reported fair or poor oral health, and all were overdue for routine dental care. At 6 months, professional dental care and abstinence did not significantly differ between arms, but abstinence favored the experimental arm and was significantly higher among experimental participants at 2 months in a complete case sensitivity analysis. Conclusions. OH4L was not effective for promoting dental care, but integrating oral health counseling with quitline counseling may offer some advantage for smoking cessation. Public Health Implications. We offer a model for conducting semipragmatic trials and partnering with tobacco quitlines to evaluate population-level public health interventions.

Most smokers do not use evidence-based smoking cessation treatment. Increasing utilization of these services is an important public health goal. Health care systems and insurers are well positioned to support this goal within their patient populations. We tested whether a brief, mail-based intervention increased utilization of tobacco cessation services among insured smokers. Adult smokers were identified via automated health plan data and randomized to one of five treatment arms (n = 4767). Randomization was stratified by gender, age, and type of health plan coverage. Three arms received a letter containing motivational content and treatment referral information. Motivational content emphasized either the financial, health, or values-based benefits of quitting. One arm received a referral letter with no motivational content, and one arm received no letter. Enrollment in the referred tobacco cessation program was monitored for 5 months. Treatment was available to all participants through their insurance. Across all four letter conditions, 0.8% of participants enrolled in tobacco treatment compared to 0.9% in the no letter reference group (p = .69). No single letter condition was superior to the others (p = .71), but treatment uptake was greater among participants who received their care and coverage from the health plan versus those with insurance coverage only (1.2% vs. 0.3%, p

Background and aims Millions of people world-wide use websites to help them quit smoking, but effectiveness trials have an average 34% follow-up data retention rate and an average 9% quit rate. We compared the quit rates of a website using a new behavioral approach called Acceptance and Commitment Therapy (ACT; WebQuit.org) with the current standard of the National Cancer Institute's (NCI) Smokefree.gov website. Design A two-arm stratified double-blind individually randomized trial (n = 1319 for WebQuit; n = 1318 for Smokefree.gov) with 12-month follow-up. Setting United States. Participants Adults (n = 2637) who currently smoked at least five cigarettes per day were recruited from March 2014 to August 2015. At baseline, participants were mean [standard deviation (SD)] age 46.2 years (13.4), 79% women and 73% white. Interventions WebQuit.org website (experimental) provided ACT for smoking cessation; Smokefree.gov website (comparison) followed US Clinical Practice Guidelines for smoking cessation. Measurements The primary outcome was self-reported 30-day point prevalence abstinence at 12 months. Findings The 12-month follow-up data retention rate was 88% (2309 of 2637). The 30-day point prevalence abstinence rates at the 12-month follow-up were 24% (278 of 1141) for WebQuit.org and 26% (305 of 1168) for Smokefree.gov [odds ratio (OR) = 0.91; 95% confidence interval (CI) = 0.76, 1.10; P = 0.334] in the a priori complete case analysis. Abstinence rates were 21% (278 of 1319) for WebQuit.org and 23% (305 of 1318) for Smokefree.gov (OR = 0.89 (0.74, 1.07; P = 0.200) when missing cases were imputed as smokers. The Bayes factor comparing the primary abstinence outcome was 0.17, indicating 'substantial' evidence of no difference between groups. Conclusions WebQuit.org and Smokefree.gov had similar 30-day point prevalence abstinence rates at 12 months that were descriptively higher than those of prior published website-delivered interventions and telephone counselor-delivered interventions.

BACKGROUND AND OBJECTIVES Despite clear associations between social anxiety (SA), high prevalence of smoking, and cessation failure, little is known about factors contributing to these relationships. Moreover, the extent to which smokers with moderate SA represent an at-risk group of smokers is also unknown. This study examined the extent to which established risk factors for poor cessation (eg, sociodemographic, smoking history, mental health comorbidity) are prevalent among smokers with low, moderate, and high levels of SA. METHODS Participants (N = 2,637) were adult smokers from a web-based smoking cessation trial. Nineteen characteristics considered risk factors for poor cessation outcomes were assessed at baseline. Those associated with social anxiety were subsequently compared by SA level. RESULTS Regression models indicated that 10/19 risk factors were associated with SA. Compared to smokers with low SA, those with moderate and high SA endorsed 4/10 and 10/10 risk factors as more prevalent or severe, respectively. Compared to smokers with low SA, High SA was associated with greater sociodemographic risk factors, while both moderate and high SA was associated with more severe mental health symptoms. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE Smokers with moderate and high levels of SA endorse more risk factors for poor cessation outcomes than those with low levels of SA, particularly mental health symptoms. These factors may help explain the differential smoking outcomes of socially anxious smokers. Results suggest that smokers with both moderate and high levels of SA would likely benefit from cessation interventions that address and consider these risk factors. (Am J Addict 2017;26:176-182).

Introduction Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments. Methods Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization. Results Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home. Conclusions Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers’ willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions. Implications The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers’ willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.

Introduction Preliminary trial data suggest group-delivered acceptance and commitment therapy (ACT) might be effective for smoking cessation. If so, this could offer a viable alternative to mainstream behavioral therapies, such as those grounded in cognitive behavioral therapy (CBT). The goal of the current study was to compare the effectiveness of group-delivered ACT versus group-delivered CBT in a rigorous randomized trial design with long-term follow-up. Methods Participants (n = 450) were recruited from the Kaiser Permanente Washington health care system and randomized to either ACT-based group counseling or an attention-matched CBT-based group program. All were prescribed an 8-week course of nicotine patches. The primary outcome was self-reported 30-day point prevalence abstinence at 12 months post-randomization assessed with missing values imputed as smoking. Sensitivity analyses using multiple imputation and complete cases were examined, as were biochemically confirmed and 6-month outcomes. Results Thirty-day point prevalence abstinence rates at the 12-month follow-up did not differ between study arms in the primary analysis (13.8% ACT vs. 18.1% CBT, adjusted odds ratio = 0.68 [95% CI = 0.35 to 1.27], p = .23) or the sensitivity analyses. Conclusions Group-based ACT and CBT had similar long-term quit rates in this methodologically rigorous randomized trial. Group-based ACT is a reasonable alternative to group-based CBT for smoking cessation. Implications This study compared the effectiveness of group-based ACT with group-based CBT for smoking cessation using a rigorous, large-scale, attention-matched, randomized trial with 1-year follow-up. One-year cessation rates did not differ between group-based ACT and CBT, suggesting ACT-based intervention is a reasonable alternative to CBT-based counseling for smoking cessation. The results add to the nascent but growing literature assessing ACT and other mindfulness-based treatments for smoking cessation.

Background The extent to which smokers with bipolar disorder (BD) differ from other smokers on cessation-related characteristics and outcomes is unknown and could improve knowledge of treatment needs for this group. These analyses compared smokers with BD versus smokers with other affective disorders (ADs; anxiety and unipolar depression) and smokers with no mental health conditions (MHCs). Method Participants (n = 2570) were a subsample of those enrolled in a smoking cessation trial comparing two web-delivered intervention approaches: acceptance and commitment therapy (ACT) and cognitive behavioral therapy. Those included in this analysis self-reported having BD (n = 221), other ADs (n = 783) or no major MHCs (n = 1566). Surveys assessed baseline characteristics and self-reported abstinence at 3, 6, and 12-months post-randomization. Treatment utilization was tracked via page views. Results Smokers with BD were distinct from both AD and no MHC smokers on the majority of baseline characteristics. At 12-months, quit rates were lower for smokers with BD (20%) than no MHCs (29%; p = 0.01), but no different than other ADs (20%; p = .467). Interactions between treatment assignment and diagnostic group were non-significant for cessation outcome. The number of logins was higher for smokers with BD than AD in the ACT arm only (p = .001), but this finding was not replicated across other utilization indicators. Conclusions Smokers with BD and other ADs had similar long-term quit rates despite numerous differences in baseline characteristics. Despite being lower than for smokers without MHCs, long-term quit rates from web-based treatment are promising for smokers with BD as well as other ADs.

peer-funded The study objectives were to: 1) evaluate the diagnostic performance of passive immunity tests for classification of failure of passive transfer (FPT) risk, based on their relationships with calf health and performance, and 2) describe the epidemiology of morbidity and mortality in suckler beef and dairy calves under Irish conditions. A total of 1392 suckler beef calves (n = 111 farms) and 2090 dairy calves (84 farms) were included in this observational study. Blood samples were collected by jugular venipuncture. Serum samples were analysed for total IgG concentration using an ELISA assay, total protein concentration by clinical analyser (TP – CA), globulin concentration, zinc sulphate turbidity (ZST) units, total solids percentage by Brix refractometer (TS – BRIX), and total protein concentration by digital refractometer (TP – DR). Crude and cause-specific morbidity, all-cause mortality, and standardised 205-day body weight (BW) were determined. Generalised linear mixed models were used to evaluate associations between suckler beef and dairy calves for morbidity, mortality, growth and passive immunity. Receiver operating characteristic (ROC) curves were constructed to determine optimal test cut-offs for classification of health and growth outcomes. Overall, 20% of suckler beef and 30% of dairy calves were treated for at least one disease event by 6 mo. of age. Suckler beef calves had greater odds of bovine respiratory disease (BRD; odds ratio (OR), 95% confidence interval (CI): 2.8, 1.2–6.5, P = 0.01), navel infection (5.1, 1.9–13.2, P

OBJECTIVE:Smokers with bipolar disorder (BD) have low rates of successful quitting, yet no prior studies have evaluated the process of quitting among these smokers in the context of a current quit attempt. To facilitate development of more effective interventions, we conducted a qualitative exploration of challenges and facilitators of quitting in an intervention study for smokers with BD. METHODS:Participants were adult daily smokers with BD (n = 10) who completed a 10-week smoking cessation intervention consisting of Acceptance and Commitment Therapy (ACT) and nicotine patch. We administered semistructured interviews focused on the quitting process at the end of treatment and used inductive content analysis to extract themes. RESULTS:Emergent themes representing challenges of quitting included social impediments, lack of awareness, avoidance, maladaptive beliefs, ambivalence, benefits of smoking, and difficulties with nicotine replacement. Themes representing change facilitators included positive treatment effects (ACT-specific, nonspecific, and nicotine patch-related), coping behaviors, reasons to quit, changes in self-perception, and social benefits. CONCLUSIONS:Results suggest a need for assistance with obtaining social support and handling social impediments, interrupting the automaticity of smoking, expanding the behavioral repertoire to handle aversive internal states that tend to be avoided by smoking, preventing maladaptive beliefs from interfering with quitting, taking meaningful action toward change while experiencing ambivalence, either replacing the benefits of smoking or accepting their loss, and troubleshooting difficulties with nicotine replacement. Findings regarding facilitators of quitting supported previous quantitative findings that the ACT intervention impacted theory-based targets and highlighted the importance of the counseling relationship.

Cigarette smoking is two to three times more prevalent among people with bipolar disorder than among people without psychiatric disorders, and quit rates are one-half that of smokers without psychiatric disorders (1). These substantial differences in smoking prevalence and cessation contribute to numerous tobacco-related health disparities, including a 25-year differential in life expectancy (2) and elevated rates of chronic obstructive pulmonary disease, hypertension, and asthma (3). Treatment as usual has failed to address these disparities. New intervention approaches are needed to assist smokers with bipolar disorder to quit successfully. Very few smoking cessation studies have focused specifically on smokers with bipolar disorder. Extant studies, with sample sizes ranging from five to 60 participants, have tested the safety and efficacy of varenicline (4–6) and bupropion (7). Our prior pilot study (n = 10) of an in-person, individual mood management intervention based on cognitive-behavioral therapy (CBT), combined with nicotine patch, is the only study to date of a targeted behavioral intervention for smokers with bipolar disorder (8). In that study, we determined that the CBT-based mood management intervention combined with transdermal nicotine patch produced a 20% quit rate at the end of the 12-week treatment period, but the counseling was not uniformly acceptable to participants because it lacked the flexibility needed to address heterogeneous reasons for smoking (8). This finding prompted us to change our treatment model and conduct a new series of pilot feasibility studies. We hypothesized that smokers with bipolar disorder might find a new treatment based on Acceptance and Commitment Therapy (ACT) both acceptable and effective for two key reasons. First, the accumulating evidence comparing ACT with standard care smoking cessation counseling in multiple modalities (Internet, telephone, and smartphone application) suggests that this treatment approach holds promise for improving cessation outcomes by 50–150% (9–11). Second, ACT targets a unique mechanism of change—acceptance, defined as willingness to experience discomfort or distress in order to make a meaningful life change (12). For smokers with bipolar disorder, acceptance of mood symptoms as well as other barriers to cessation in this group (13) may be particularly important for sustained efforts to quit. In this study, we evaluated an ACT-based cessation program for adults with bipolar disorder to determine its acceptability, efficacy, and impact on its theory-based change mechanism (i.e., acceptance). Two modes of delivery were examined in sequential, single-arm studies: in-person (because of its depth and the ability to observe face-to-face how participants reacted to the new treatment) and telephone (because of its reach and future dissemination potential through tobacco quitlines, as well as our emerging data suggesting that telephone-delivered ACT for smoking cessation in a general population sample was feasible, well-received, and increased the odds of quitting by 50% as compared to standard tobacco quitline treatment (10)). Recruitment and retention rates were also monitored to inform the feasibility of each modality.

Ecological momentary assessment was used to examine associations between negative affect, positive smoking outcome expectancies, and smoking urge during the first 7 days of a smoking quit attempt. Participants were 302 female smokers who enrolled in an individually tailored smoking cessation treatment study. Multilevel mediation analysis was used to examine the temporal relationship among the following: (a) the effects of negative affect and positive smoking outcome expectancies at 1 assessment point (e.g., time j) on smoking urge at the subsequent time point (e.g., time j + 1) in Model 1; and, (b) the effects of negative affect and smoking urge at time j on positive smoking outcome expectancies at time j + 1 in Model 2. The results from Model 1 showed a statistically significant effect of negative affect at time j on smoking urge at time j + 1, and this effect was mediated by positive smoking outcome expectancies at time j, both within- and between-participants. In Model 2, the within-participant indirect effect of negative affect at time j on positive smoking outcome expectancies at time j + 1 through smoking urge at time j was nonsignificant. However, a statistically significant indirect between-participants effect was found in Model 2. The findings support the hypothesis that urge and positive smoking outcome expectancies increase as a function of negative affect, and suggest a stronger effect of expectancies on urge as opposed to the effect of urge on expectancies.

Social learning models of addiction hypothesize that situational factors interact with cognitive determinants to influence a person's motivation to use substances. Ecological momentary assessment was used to examine the association between alcohol consumption, smoking outcome expectancies, and smoking urge during the first 7 days of a smoking quit attempt. Participants were 113 female smokers who enrolled in a study that tested an individually tailored smoking cessation treatment. Participants carried a palm-top personal computer for 7 days and were instructed to complete 4 random assessments each day and to initiate an assessment when they were tempted to smoke. Multilevel mediational analyses were used to examine (a) the effects of alcohol consumption before time j and positive smoking outcome expectancies at time j on smoking urge at time j + 1 (Model 1) and (b) the effects of alcohol consumption before time j and smoking urge at time j on positive smoking outcome expectancies at time j + 1 (Model 2). Model 1 found a significant effect of alcohol consumption before time j on smoking urge at time j + 1 (p = .04), and this effect was significantly mediated by positive smoking outcome expectancies at time j (p < .0001). Model 2 failed to find a significant effect of alcohol consumption before time j on positive smoking outcome expectancies at time j + 1. The findings suggest that alcohol consumption is significantly associated with increased positive smoking outcome expectancies that, in turn, are associated with increased smoking urge in women seeking to quit smoking.

Introduction Negative affect, alcohol consumption, and presence of others smoking have consistently been implicated as risk factors for smoking lapse and relapse. What is not known, however, is how these factors work together to affect smoking outcomes. This paper uses ecological momentary assessment (EMA) collected during the first 7 days of a smoking cessation attempt to test the individual and combined effects of high-risk triggers on smoking urge and lapse. Methods Participants were 300 female smokers who enrolled in a study that tested an individually tailored smoking cessation treatment. Participants completed EMA, which recorded negative affect, alcohol consumption, presence of others smoking, smoking urge, and smoking lapse, for 7 days starting on their quit date. Results Alcohol consumption, presence of others smoking, and negative affect were, independently and in combination, associated with increase in smoking urge and lapse. The results also found that the relationship between presence of others smoking and lapse and the relationship between negative affect and lapse were moderated by smoking urge. Conclusions The current study found significant individual effects of alcohol consumption, presence of other smoking, and negative affect on smoking urge and lapse. Combing the triggers increased smoking urge and the risk for lapse to varying degrees, and the presence of all 3 triggers resulted in the highest urge and lapse risk.

Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services. All participants are followed for 6 months to assess the impact of the intervention on smoking abstinence and utilization of professional dental care. In addition, the study will assess the cost of the intervention and provide practical guidance to states on whether the intervention is financially feasible to implement, should the intervention be effective. This study protocol may be useful to others interested in promoting oral health among smokers, those interested in partnering with tobacco quitlines to extend standard services to address other high risk health behaviors among smokers, or those interested in semi-pragmatic trial design.

Although social anxiety is associated with higher prevalence of smoking and lower cessation rates, little is known about the underlying mechanisms of these relationships. Research suggests that socially anxious smokers have higher levels of smoking-specific experiential avoidance and are inclined to smoke to avoid internal smoking cues. However, it is unknown which types of internal smoking cues they avoid. Thus, this study aimed to address this gap in the literature.Participants (N = 450) were adult smokers from a group-based trial for smoking cessation. Bivariate correlations and hierarchical linear regression models examined relationships between baseline levels of social anxiety and acceptance of internal smoking cues-physical sensations, emotions, and cognitions.Social anxiety was associated with lower levels of acceptance of thoughts, sensations, and emotions that cue smoking. After controlling for levels of nicotine dependence, depression, generalized anxiety, and posttraumatic stress disorder, social anxiety still explained unique variability in overall acceptance of internal smoking cues and in acceptance of physical sensations and emotions that serve as smoking cues. Social anxiety no longer explained unique variability in acceptance of thoughts that trigger smoking.Smokers with high levels of social anxiety are less accepting of internal smoking cues. For physical and emotional cues, this effect was independent of level of dependence and mental health comorbidity. Results help explain why smokers with social anxiety are less likely to quit and can inform the development of targeted cessation treatments for smokers with social anxiety.

BackgroundMobile health (mHealth) interventions hold great promise for helping smokers quit since these programs can have wide reach and facilitate access to comprehensive, interactive, and adaptive treatment content. However, the feasibility, acceptability, and effectiveness of these programs remain largely untested. ObjectiveTo assess feasibility and acceptability of the My Mobile Advice Program (MyMAP) smoking cessation program and estimate its effects on smoking cessation and medication adherence to inform future research planning. MethodsSixty-six smokers ready to quit were recruited from a large regional health care system and randomized to one of two mHealth programs: (1) standard self-help including psychoeducational materials and guidance how to quit smoking or (2) an adaptive and interactive program consisting of the same standard mHealth self-help content as controls received plus a) real-time, adaptively tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. Participants in both arms were also prescribed a 12-week course of varenicline. Follow-up assessments were conducted at 2 weeks post-target quit date (TQD), 3 months post-TQD, and 5 months post-TQD. Indices of program feasibility and acceptability included acceptability ratings, utilization metrics including use of each MyMAP program component (self-help content, secure messaging, and adaptively tailored advice), and open-ended feedback from participants. Smoking abstinence and medication adherence were also assessed to estimate effects on these treatment outcomes. ResultsUtilization data indicated the MyMAP program was actively used, with higher mean program log-ins by experimental than control participants (10.6 vs 2.7, P

BackgroundHundreds of smoking cessation apps are commercially available, but most are not theory-based or designed to take advantage of mobile technology in ways that could make them more engaging and possibly more effective. Considering input from both clinical experts (who understand best practice nicotine dependence treatment requirements) to inform appropriate content and from smokers (the end users) to express their preferences is important in designing these programs in the future. ObjectiveTo assess and compare the opinions of nicotine dependence treatment providers and smokers regarding the design of future smoking cessation apps. MethodsWe surveyed providers (n=264) and smokers who own smartphones (n=40) to assess their opinions on the importance of 21 app design features. Features represented 5 domains: cost, reputation, privacy and security, content and user experience, and communication. Domains were chosen to reflect best practice treatment, leverage mobile technology to support smoking cessation, and elicit important user preferences. Data were collected between June and July 2015. ResultsMost providers agreed that mHealth apps hold promise for helping people quit smoking (203/264, 76.9%) and would recommend them to their clients/patients (201/264, 76.1%), especially if the app were empirically validated (236/264, 89.4%). Few providers believe effective cessation apps currently exist (112/264, 42.4%). Few smokers (5/40, 13%) had ever downloaded a smoking cessation app; of the ones who had not, most said they would consider doing so (29/35, 83%). Both respondent groups indicated the following features were very to extremely important to include in cessation apps: free or low cost, keeps information private, matches individual needs and interests, adapts as one’s needs and interests change, helps to manage nicotine withdrawal symptoms and medication side effects, and allows users to track their progress. Providers and smokers also indicated gaming and social media connectivity were less important than other features. Despite these similarities, the groups had significantly different opinions about the relative importance of various features. In particular, providers rated privacy as the most important feature, whereas smokers rated low cost and the ability to adaptively tailor content as the most important features. ConclusionsSmoking cessation apps hold great promise as intervention tools but only if they engage users and appropriately treat nicotine dependence. Intervention development should take into consideration the perspectives of both treatment experts and smokers. This paper highlights important perspectives from each of these groups to be considered when designing future app-based smoking cessation programs.

Introduction There is increasing evidence that response to pharmacological treatment for nicotine dependence may be moderated by genetic polymorphisms. However, the feasibility, acceptability, and impact of genetically tailoring treatment in real-world clinical settings are unknown. Methods We conducted a multiphased, mixed-methods feasibility study with current smokers to develop and evaluate a patient-centered, theoretically grounded personalized medicine treatment protocol. The initial research phase included formative work to develop intervention materials. The second phase included a randomized pilot trial to evaluate the intervention. Trial participants (n = 36) were genotyped for ANKK1 rs1800497 and were randomized to receive genetic feedback (GF) plus standard behavioral counseling (BC) for smoking cessation or BC without GF. All participants received genetically tailored pharmacotherapy (nicotine patch or bupropion). Results The intervention was feasible to implement and was acceptable to participants based on satisfaction ratings and objective measures of participation. There was no evidence that the GF resulted in adverse psychological outcomes (e.g., depression, fatalism, reduced perceived control over quitting, differential motivation for quitting) based on quantitative or qualitative outcomes. Conclusions Study results suggest that it is feasible to offer treatment within a health care setting that includes genetically tailored pharmacotherapy and doing so had no apparent adverse psychological impacts. Further evaluation of pharmacogenetically tailored smoking cessation interventions appears warranted.

Effective interventions are needed to improve smokers' motivation for quitting, treatment utilization, and abstinence rates. The Internet provides an ideal modality for delivering such interventions, given the low cost, broad reach, and capacity to individually tailor content, but important methodological questions remain about how to best design and deliver an online, motivational intervention to smokers. The current paper reports on the intervention, study design and research methods of a randomized trial (called Questions about Quitting) designed to address some of these questions. Using a Multi-phase Optimization Strategy (MOST) screening experiment, the trial has two key aims: to examine the impact of four experimental intervention factors (each evaluated on two levels) on smokers' subsequent treatment utilization and abstinence, and to examine select moderators of each sub-factor's effectiveness. The experimental factors of interest are: navigation autonomy (content viewing order is dictated based on stage of change or not), use of self-efficacy based testimonials (yes vs. no), proactive outreach (reminder emails vs. no emails), and decisional framework (prescriptive vs. motivational tone). To our knowledge, this is the first application of the MOST methodology to explore these factors or to explore the optimal design for a motivational intervention targeting smokers not actively trying to quit smoking. The rationale for the experimental factor choice, intervention design, and trial methods are discussed. Outcome data are currently being collected and are not presented, but recruitment data confirm the feasibility of enrolling smokers at varying stages of readiness to quit.

Patient adherence to smoking cessation medications can impact their effectiveness. It is important to understand the extent to which prescribed medications are actually taken by smokers, how this influences smoking cessation outcomes, and what factors may influence adherence.Smokers recruited from a large health plan were randomized to receive different modes of cessation counseling in combination with varenicline (Swan, G. E., McClure, J. B., Jack, L. M., Zbikowski, S. M., Javitz, H. S., Catz, S. L., et al. 2010.Behavioral counseling and varenicline treatment for smoking cessation. American Journal of Preventive Medicine, 38, 482-490). One thousand one hundred and sixty-one participants were mailed a 28-day varenicline supply when they set a quit date and were able to request up to two refills from the health plan pharmacy at no cost. Pharmacy fill records were obtained and telephone surveys completed at baseline, 21 days, 12 weeks, and 6 months post target quit date.Good adherence to varenicline (≥80% of days taken) was associated with a twofold increase in 6-month quit rates compared with poor adherence (52% vs. 25%). Smokers were more likely than nonsmokers to stop varenicline early. Purposeful nonadherence was associated with smoking at 12 weeks and was predicted in multivariate analyses by age, gender, adherence self-efficacy, and initial medication side effect severity.Innovative methods for increasing adherence to smoking cessation medications are needed, particularly early in the quit process. Simple metrics of adherence such as number of days cessation medication is taken can and should be routinely incorporated in effectiveness trials and reported to advance future attempts to understand and reduce nonadherence.

Background: Despite having many advantages, online eHealth trials are not without challenges—notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies. Objective: To address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions. Methods: To ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification. Results: We randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source. Conclusions: Continuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials. Trial Registration: ClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO)

Background: Little is known about how individuals engage with electronic health (eHealth) interventions over time and whether this engagement predicts health outcomes. Objective: The objectives of this study, by using the example of a specific type of eHealth intervention (ie, websites for smoking cessation), were to determine (1) distinct groups of log-in trajectories over a 12-month period, (2) their association with smoking cessation, and (3) baseline user characteristics that predict trajectory group membership. Methods: We conducted a functional clustering analysis of 365 consecutive days of log-in data from both arms of a large (N=2637) randomized trial of 2 website interventions for smoking cessation (WebQuit and Smokefree), with a primary outcome of 30-day point prevalence smoking abstinence at 12 months. We conducted analyses for each website separately. Results: A total of 3 distinct trajectory groups emerged for each website. For WebQuit, participants were clustered into 3 groups: 1-week users (682/1240, 55.00% of the sample), 5-week users (399/1240, 32.18%), and 52-week users (159/1240, 12.82%). Compared with the 1-week users, the 5- and 52-week users had 57% higher odds (odds ratio [OR] 1.57, 95% CI 1.13-2.17; P=.007) and 124% higher odds (OR 2.24, 95% CI 1.45-3.43; P

Background Few studies have rigorously evaluated whether providing biologically based health-risk feedback is more effective than standard interventions in increasing smokers' motivation to quit and their long-term abstinence. Design An RCT was conducted from 2005 to 2008. Data were analyzed in 2008. Setting/participants Smokers (N=536) were recruited from the community, regardless of their interest in quitting smoking. Intervention Smokers either received brief (∼20 minutes), personally tailored counseling sessions based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions, or they received generic smoking-risk information and personalized counseling about their diet, BMI, and physical activity. All were advised to quit smoking and were offered access to a free phone-counseling program. Main outcome measures Treatment utilization and abstinence at 6 and 12 months post-intervention. Results Participants who received the experimental treatment demonstrated no greater motivation to quit, use of treatment services, or abstinence compared to controls at either follow-up assessment. In fact, controls reported greater motivation to quit at 12 months (M 3.42 vs 3.20, p =0.03), greater use of pharmacotherapy at 6 months (37.8% vs 28.0%, p =0.02), and greater 30-day point prevalent abstinence at 6 months, after controlling for relevant covariates (10.8% vs 6.4%, adjusted p =0.04). Conclusions The present study found no support for adding a personalized health-risk assessment emphasizing lung health and CO exposure to generic cessation advice and counseling for community-based smokers not otherwise seeking treatment. Trial registration NCT00169260 .

This paper examines reported symptoms, nonsmoking rates, and medication use among 1018 smokers using varenicline in a randomized trial comparing three forms of behavioral support for smoking cessation (phone, web, or phone + web). One month after beginning varenicline, 168 people (17%) had discontinued the medication. Most (53%) quit due to side-effects and other symptoms. The most common side-effect among all users was nausea (reported by 57% of users). At one month post medication initiation, those not taking varenicline were more likely to report smoking than those who continued the medication (57% vs. 16%, p

INTRODUCTION Providing smokers with biologically based evidence of smoking-related disease risk or physical impairment may be an effective way to motivate cessation. METHODS Smokers were recruited for a free health risk assessment and randomized to receive personally tailored feedback based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions or generic information about the risks of smoking and personalized counseling based on their diet, body mass index, and physical activity. All (n = 536) were advised to quit smoking and offered access to a free telephone cessation program. Participants were surveyed immediately after intervention and 1 month later to assess the impact on various indices of motivation to quit. RESULTS Immediately posttreatment, experimental participants rated themselves as more likely to try to quit (p = .02) and reported a greater mean increase in their motivation to quit than controls (p = .04). At 1-month follow-up, however, we found no significant group differences on any motivational indices. In post-hoc analyses comparing smokers in the experimental group with and without lung impairment, persons with impaired lung functioning had a greater change from baseline in posttreatment motivation to quit (adjusted p = .05) and perceived risk of developing a smoking-related disease (p = .03) compared with persons with no lung impairment, but we found no significant treatment effect on any motivational indices at 1 month. DISCUSSION The results suggest that the intervention had a small, temporary effect, but we found no clear evidence that the intervention increased motivation to quit smoking during the first month postintervention.

Background State-level tobacco quitlines are integrating nicotine replacement therapy (NRT) into service. Because of funding limitations some provide short courses of NRT. No randomized trial has evaluated the relative benefit of short versus standard treatment. Design A two-cell randomized trial comparing 2 weeks of NRT to 8 weeks. Setting/participants Uninsured callers to the Oregon Quit Line during a free-patch initiative from October 18, 2004, to May 5, 2005, who were 18 years or older, smoked five or more cigarettes per day, did not have a medical contraindication to NRT use, and were interested in quitting in 30 days. Data were collected from April to November 2005, and analyzed in 2006–2007. Intervention Participants were eligible for two phone counseling sessions. 1154 participants were randomized to receive via the mail either 2 or 8 weeks of nicotine patches. Measures Primary outcome was self-reported complete abstinence from tobacco for 30 or more days at the 6-month phone survey. Secondary outcomes were 7-day point prevalence and 90-day abstinence, satisfaction, and patch use. ORs and CIs were computed. Cost per quit and incremental cost per additional quit were computed based on program costs. Results Intent-to-treat 30-day abstinence was 14.3% in the 2-week group, and 19.6% in the 8-week group (OR 1.45 [CI=1.01, 2.12]). Average cost per quit was $1156 for 2 weeks and $1405 for 8 weeks, with an incremental cost effectiveness of $2068. Satisfaction increased from 90% to 97% with 8 weeks. Those receiving 8 weeks of NRT took more calls (2.0 vs 1.6) and used more patches (6.3 weeks vs 4.3 weeks), but were less likely to purchase patches (16.2% vs 39.3%). Conclusions Eight weeks of patches improved quit rates compared with 2 weeks, and was cost effective.

Background Initial trials of web-based smoking-cessation programs have generally been promising. The active components of these programs, however, are not well understood. This study aimed to (1) identify active psychosocial and communication components of a web-based smoking-cessation intervention and (2) examine the impact of increasing the tailoring depth on smoking cessation. Design Randomized fractional factorial design. Setting Two HMOs: Group Health in Washington State and Henry Ford Health System in Michigan. Participants 1866 smokers. Intervention A web-based smoking-cessation program plus nicotine patch. Five components of the intervention were randomized using a fractional factorial design: high- versus low-depth tailored success story, outcome expectation, and efficacy expectation messages; high- versus low-personalized source; and multiple versus single exposure to the intervention components. Measurements Primary outcome was 7 day point-prevalence abstinence at the 6-month follow-up. Findings Abstinence was most influenced by high-depth tailored success stories and a high-personalized message source. The cumulative assignment of the three tailoring depth factors also resulted in increasing the rates of 6-month cessation, demonstrating an effect of tailoring depth. Conclusions The study identified relevant components of smoking-cessation interventions that should be generalizable to other cessation interventions. The study also demonstrated the importance of higher-depth tailoring in smoking-cessation programs. Finally, the use of a novel fractional factorial design allowed efficient examination of the study aims. The rapidly changing interfaces, software, and capabilities of eHealth are likely to require such dynamic experimental approaches to intervention discovery.

Aim: To examine heterogeneity in outcome at 12 months following 8 weeks of treatment for smoking cessation with bupropion sustained-release (SR) 150 or 300 mg/day combined with behavioural counselling. Design, setting, participants: Smokers were recruited from a large healthcare system and then randomized to receive either bupropion SR 150 mg/day (n = 763) or 300 mg/day (n = 761) taken for 8 weeks in combination with either proactive telephone counselling or a tailored mail approach. Measurements and findings: A comprehensive set of relevant individual pre-treatment and treatment characteristics was included in the analysis. Smoking outcome at 12 months was defined as point-prevalence of any regular self-reported smoking within the 7 days prior to follow-up contact. Classification and regression tree analysis identified subgroups that varied with respect to likelihood of being nonsmokers at 12 months. Seven subgroups were identified among those receiving bupropion SR 150 mg/day (proportion of nonsmokers at 12 months ranged from 13.7% to 43.5%) and eight subgroups among those receiving bupropion SR 300 mg/day (proportion of nonsmokers at 12 months ranged from 9.6% to 51.7%). In the 150-mg/day group, those with the lowest rate reported no previous quit attempt of 1 month or more in duration while those with the highest rate all reported previous quit attempts of 1 month or longer. In the 300 mg/day group, those with the lowest rate had very high levels of dependence while those with the highest rate were more highly educated and smoked at a lower level. Across all subgroups, cost per 12-month quitter ranged from a low of $US302 to a high of $US2502. Conclusions: These results indicate the presence of a substantial amount of variation in outcome following treatment with both dosages of bupropion SR, with substantial cost consequences. Variation in outcome could be reduced by providing treatments tailored to subgroups of individuals who are at exceptionally high risk for smoking following a quit attempt.

© 2015 Bergen et al. The Nicotine Metabolite Ratio (NMR, ratio of trans-3'-hydroxycotinine and cotinine), has previously been associated with CYP2A6 activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET) gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs) at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; CYP2A6 and two CYP2A6 SNPs attained experiment-wide significance adjusted for correlated SNPs (CYP2A6 PACT=4.1E-7, rs4803381 PACT=4.5E-5, rs1137115, PACT=1.2E-3). Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In post-hoc analyses of CYP2A6 SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. CYP2A6 minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that CYP2A6 plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis.

Nicotine replacement therapy (NRT) is an effective treatment for smoking cessation, but as with all such pharmacotherapies, the majority of smokers who use NRT products do not stop smoking or remain abstinent long term. Treatment outcome is affected by a range of individual-specific factors, as well as the pharmacokinetic profile of each NRT formulation. This has led to speculation that abstinence rates could be improved if NRT treatments were individually tailored to best match each individual’s needs and preferences. There are also populations for whom special product and dosage considerations are warranted to maximise treatment safety. This paper reviews the rationale for NRT treatment, standard dose recommendations and recommendations for how to best match NRT treatment to the specific needs of individual smokers. We also review emerging evidence that genetic profiling may one day be a useful consideration for tailoring NRT treatment.

Current treatment guidelines recommend that all smokers be given motivational or action-oriented counseling, as is appropriate to their readiness to quit smoking. The present study assessed the acceptability and impact of a proactively delivered, motivationally tailored phone counseling program targeted to women with elevated risk for cervical cancer. Female smokers with a recent abnormal pap exam or a colposcopy were contacted and invited to participate, regardless of their interest in quitting smoking. Participants were randomly assigned to usual care (UC) or UC plus motivationally enhanced phone counseling (MEC). The intervention was well received: 79% of eligible women enrolled (n = 275), and 90% completed at least three of four calls. Participation did not vary by baseline motivation to quit. Compared with control subjects, counseling participants were more likely to seek additional treatment services and had a higher 7-day point-prevalence abstinence rate at 6 months (20% MEC vs. 12% UC, p

Self-administered treatment for smoking cessation has the potential to reach a broad spectrum of the population of smokers. This article focuses on self-administration of behavioral and pharmacological treatments for smoking cessation. Evidence for the effectiveness of written manuals to self-administer behavioral treatment is mixed. There is no evidence that self-help manuals alone are effective. However, they do increase quit rates when combined with personalized adjuncts such as written feedback and outreach telephone counseling. Efficacy trials of first-line pharmacotherapies (nicotine gum, nicotine patch, and bupropion) result in doubling of cessation rates compared to placebo. It is difficult to evaluate the effectiveness of pharmacotherapies when self-administered under real-world conditions. The general consensus is that they improve quit rates, although poor compliance and early discontinuation reduce their effectiveness. Areas for further research include randomized trials of the use of new technologies (e.g., hand-held computers and the Internet) to disseminate self-administered treatments as well as improved surveillance of the use of self-administered treatment in population-based health surveys. © 2003 Wiley Periodicals, Inc. J Clin Psychol 59: 305–319, 2003.

The current study examined the relation between drinking and smoking abstinence in a community-based sample from the Working Well Trial (WWT). At baseline, drinking level was related to smoking history (never, former, or current smoker; P P P P P =.06). The results suggest (a) a dose–response relation between baseline drinking and duration of smoking abstinence, and (b) that heavier drinkers are less likely to quit smoking over a 4-year period.

BackgroundMobile health (mHealth) smoking cessation programs are typically designed for smokers who are ready to quit smoking. In contrast, most smokers want to quit someday but are not yet ready to quit. If mHealth apps were designed for these smokers, they could potentially encourage and assist more people to quit smoking. No prior studies have specifically examined the design considerations of mHealth apps targeting smokers who are not yet ready to quit. ObjectiveTo inform the user-centered design of mHealth apps for smokers who were not yet ready to quit by assessing (1) whether these smokers were interested in using mHealth tools to change their smoking behavior; (2) their preferred features, functionality, and content of mHealth programs addressing smoking; and (3) considerations for marketing or distributing these programs to promote their uptake. MethodsWe conducted a sequential exploratory, mixed-methods study. Qualitative interviews (phase 1, n=15) were completed with a demographically diverse group of smokers who were smartphone owners and wanted to quit smoking someday, but not yet. Findings informed a Web-based survey of smokers from across the United States (phase 2, n=116). Data were collected from April to September, 2016. ResultsFindings confirmed that although smokers not yet ready to quit are not actively seeking treatment or using cessation apps, most would be interested in using these programs to help them reduce or change their smoking behavior. Among phase 2 survey respondents, the app features, functions, and content rated most highly were (1) security of personal information; (2) the ability to track smoking, spending, and savings; (3) content that adaptively changes with one’s needs; (4) the ability to request support as needed; (5) the ability to earn and redeem awards for program use; (6) guidance on how to quit smoking; and (7) content specifically addressing management of nicotine withdrawal, stress, depression, and anxiety. Results generally did not vary by stage of change for quitting smoking (precontemplation vs contemplation). The least popular feature was the ability to share progress via social media. Relevant to future marketing or distribution considerations, smokers were price-sensitive and valued empirically validated programs. Program source, expert recommendations, and user ratings were also important considerations. ConclusionsSmokers who are not yet ready to quit represent an important target group for intervention. Study findings suggest that many of these individuals are receptive to using mHealth tools to reduce or quit smoking, despite not having made a commitment to quit yet. The preferences for specific mHealth intervention features, functionality, and content outlined in this paper can aid addiction treatment experts, design specialists, and software developers interested in creating engaging interventions for smokers who want to quit in the future but are not yet committed to this important health goal.

Author(s): Bergen, Andrew W; Javitz, Harold S; Krasnow, Ruth; Michel, Martha; Nishita, Denise; Conti, David V; Edlund, Christopher K; Kwok, Pui-Yan; McClure, Jennifer B; Kim, Richard B; Hall, Sharon M; Tyndale, Rachel F; Baker, Timothy B; Benowitz, Neal L; Swan, Gary E | Abstract: IntroductionWe evaluated chr6q25.3 organic cation transporter gene (SLC22A1, SLC22A2, SLC22A3) variation and response to smoking cessation therapies. The corresponding proteins are low-affinity transporters of choline, acetylcholine and monoamines, and smoking cessation pharmacotherapies expressed in multiple tissues.MethodsWe selected 7 common polymorphisms for mega-regression analysis. We assessed additive model association of polymorphisms with 7-day point prevalence abstinence overall and by assigned pharmacotherapy at end of treatment and at 6 months among European-ancestry participants of 7 randomized controlled trials adjusted for demographic, population genetic, and trial covariates.ResultsInitial results were obtained in 6 trials with 1,839 participants. Nominally statistically significant associations of 2 SLC22A2 polymorphisms were observed: (1) with rs316019 at 6 months, overall ([c.808TgG; p.Ser270Ala], OR = 1.306, 95% CI = 1.034-1.649, p = .025), and among those randomized to nicotine replacement therapy (NRT) (OR = 1.784, 95% CI = 1.072-2.970, p = .026); and (2) with rs316006 (c.1502-529AgT) among those randomized to varenicline (OR = 1.420, 95% CI = 1.038-1.944, p = .028, OR = 1.362, 95% CI = 1.001-1.853, p = .04) at end of treatment and 6 months. Individuals randomized to NRT from a seventh trial were genotyped for rs316019; rs316019 was associated with a nominally statistically significant effect on abstinence overall at 6 months among 2,233 participants (OR = 1.249, 95% CI = 1.007-1.550, p = .043).ConclusionsThe functional OCT2 Ser270Ala polymorphism is nominally statistically significantly associated with abstinence among European-ancestry treatment-seeking smokers after adjustments for pharmacotherapy, demographics, population genetics, and without adjustment for multiple testing of 7 SNPs. Replication of these preliminary findings in additional randomized controlled trials of smoking cessation therapies and from multiple continental populations would describe another pharmacogenetic role for SLC22A2/OCT2.

Introduction Research needs to systematically identify which components increase online intervention effectiveness (i.e., active ingredients). This study explores the effects of 4 potentially important design features in an Internet-based, population-level smoking intervention. Methods Smokers (n = 1,865) were recruited from a large health care organization, regardless of readiness to quit. Using a full factorial design, participants were randomized to 1 of the 2 levels of each experimental factor (message tone [prescriptive vs. motivational], navigation autonomy [dictated vs. not], e-mail reminders [yes vs. no], and receipt of personally tailored testimonials [yes vs. no]) and provided access to the online intervention. Primary outcomes were self-reported 7-day point-prevalent smoking abstinence and confirmed utilization of adjunct treatment (pharmacotherapy or phone counseling) available through the health plan at 1 year. Outcomes were also assessed at 2 and 6 months and were examined among all enrolled participants (intent-to-treat [ITT]) and all who viewed the intervention (modified ITT). Results At 1 year, 13.7% were abstinent and 26.0% utilized adjunct treatment. None of the contrasting factor levels differentially influenced abstinence or treatment utilization at 12 months. In the modified ITT sample, smokers receiving testimonials were less likely to use adjunct treatment at 6 months (odds ratio = 0.54, 95% confidence interval = 0.30-0.98, p = .04). Conclusions None of the design features enhanced treatment outcome. The negative effect observed for testimonials is provocative, but it should be viewed with caution. This study offers a model for future research testing the "active ingredients" of online interventions.

Although tobacco smoking has long been recognized as having negative health consequences, more than one quarter of the US adult population smokes. This article presents (a) national trends in the prevalence of tobacco smoking, (b) health consequences associated with tobacco smoking and tobacco's mode of action (how tobacco/nicotine cause the problems), and (c) a brief overview of the smoking cessation treatment literature and several recommendations based on the review of research.

BackgroundAccurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement. This can be calculated from time-stamped data reflecting navigation to and from individual webpages. Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration. Unfortunately, this practice can lead to biased results describing program exposure. ObjectiveThe aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out. MethodsTo illustrate this method, we present data on time-outs collected from the Q2 randomized smoking cessation trial. For this analysis, we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone. Using multiple imputations, we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models. We calculated standard errors using Rubin’s formulas to account for the variability due to the imputations. We also illustrate how current methods of accounting for time-outs (excluding timed-out page views or assigning an arbitrary viewing time) can influence conclusions about participant engagement. ResultsA total of 63.00% (1175/1865) of participants accessed the online intervention in the Q2 trial. Of the 6592 unique page views, 683 (10.36%, 683/6592) resulted in a time-out. The median time spent viewing webpages that did not result in a time-out was 1.07 minutes. Assuming participants did not spend any time viewing a webpage that resulted in a time-out, no difference between the two message tones was observed (ratio of mean time online: 0.87, 95% CI 0.75-1.02). Assigning 30 minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content (ratio of mean time online: 0.86, 95% CI 0.77-0.98) than those participants who received content in a prescriptive tone. Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones (ratio of mean time online: 0.87; 95% CI 0.75-1.01). ConclusionsThe analytic technique chosen can significantly affect conclusions about online intervention engagement. We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations. Trial RegistrationClinicaltrials.gov NCT00992264; http://clinicaltrials.gov/ct2/show/NCT00992264 (Archived by WebCite at http://www.webcitation.org/6Kw5m8EkP).

Background: Participant engagement influences treatment effectiveness, but it is unknown which intervention design features increase treatment engagement for online smoking cessation programs. Objective: We explored the effects of 4 design features (ie, factors) on early engagement with an Internet-based, motivational smoking cessation program. Methods: Smokers (N=1865) were recruited from a large health care organization to participate in an online intervention study, regardless of their interest in quitting smoking. The program was intended to answer smokers’ questions about quitting in an effort to motivate and support cessation. Consistent with the screening phase in the multiphase optimization strategy (MOST), we used a 2-level, full-factorial design. Each person was randomized to 1 of 2 levels of each factor, including message tone (prescriptive vs motivational), navigation autonomy (dictated vs not), proactive email reminders (yes vs no), and inclusion of personally tailored testimonials (yes vs no). The effects of each factor level on program engagement during the first 2 months of enrollment were compared, including number of visits to the website resulting in intervention content views (as opposed to supplemental content views), number of intervention content areas viewed, number of intervention content pages viewed, and duration of time spent viewing this content, as applicable to each factor. Results: Adjusting for baseline readiness to quit, persons who received content written in a prescriptive tone made the same number of visits to the website as persons receiving content in a motivational tone, but viewed 1.17 times as many content areas (95% CI 1.08-1.28; P

Since the previous version of this chapter was published (Swan, Hudmon, & Khroyan, 2003), many advances in the science of nicotine dependence have occurred. Although progress has been significant, nicotine dependence remains a substantial global problem, the solution of which will require sustained effort at the basic, genetic, environmental (individual and macro levels), and treatment levels. In this chapter, we highlight some of the most significant developments in the field of nicotine dependence research over the past 10 years. These highlights include an increased understanding of the role of individual variation in relevant neurochemical and metabolic pathways; the emergence of neuroimaging technologies that further specify areas in the brain that are influenced by environmental cues to smoke; a remarkable series of genetic epidemiological studies that have identified and replicated an association between variation in the CHRN A5-A3-B4 nicotinic gene cluster on chromosome 15 and nicotine dependence; a more complete picture of individual-level variables that influence risk for nicotine dependence, including gender, cultural, and psychiatric comorbidities; the recent development of new assessment tools for nicotine dependence; and a summary of empirically based behavioral and pharmacological treatments for nicotine dependence. We close the chapter with a review of the recent and current macroenvironmental contextual factors in which the science has taken place in the past decade, including the master settlement agreement between the states and the tobacco industry, the impact of continued public health efforts, evidence of the cost-effectiveness of treatment for nicotine dependence, implications of health care reform for tobacco use counseling, the emergence of potential reduced exposure products into the marketplace, and global efforts at tobacco control. Keywords: smoking cessation; clinical trials; tobacco control; risk factors; neurobiology

Aversive symptoms of abstinence from nicotine have been posited to lead to smoking relapse and research on temporal patterns of abstinence symptoms confirms this assumption. However, little is known about the association of symptom trajectories early after quitting with post-cessation smoking or about the differential effects of tonic (background) versus phasic (temptation-related) symptom trajectories on smoking status. The current study examined trajectories of urge and negative mood among 300 women using the nicotine patch during the first post-cessation week. Ecological momentary assessments collected randomly and during temptation episodes were analyzed using hierarchical linear modeling yielding four individual trajectory parameters: intercept (initial symptom level), linear slope (direction and rate of change), quadratic coefficient (curvature), and volatility (scatter). Early lapsers, who lapsed during the first post-cessation week, exhibited more severe tonic urge and phasic negative mood immediately after quitting, and more volatile tonic and phasic urge compared to abstainers. Late lapsers, who were abstinent during the first week but lapsed by 1 month, exhibited more severe tonic urge immediately after quitting compared to abstainers. These results demonstrate the importance of early post-cessation urge and negative affect and highlight the value of examining both tonic and phasic effects of abstinence from nicotine.

Background: The current study evaluated the efficacy of an individualized, hand-held computer-delivered treatment (CDT) versus standard treatment (ST) for the maintenance of smoking abstinence following a quit attempt. Methods: Participants were 303 adult daily smokers randomized to CDT or ST, plus pharmacotherapy. Abstinence though 1 year was examined using logistic random intercept models, a type of generalized linear mixed model regression. Results: Results did not support the efficacy of the CDT program through 1 year postquit in analyses adjusted for time and study site (OR = 0.84, 95% CI = 0.55–1.30), or after further adjusting for race/ethnicity, age, gender, education, marital status, and the number of cigarettes smoked per day before quitting (OR = 0.89, 95% CI = 0.57–1.39). Conclusions: CDT did not increase short- or long-term abstinence rates over ST in this study. Impact: Findings differ from some in the literature and suggest the need for continued research on the use of CDT for smoking cessation. Cancer Epidemiol Biomarkers Prev; 20(7); 1555–7. ©2011 AACR.

This study evaluated association between common and rare sequence variants in 10 nicotinic acetylcholine receptor subunit genes and the severity of nausea 21 days after initiating the standard, Food and Drug Administration-approved varenicline regimen for smoking cessation. A total of 397 participants from a randomized clinical effectiveness trial with complete clinical and DNA resequencing data were included in the analysis (mean age=49.2 years; 68.0% female). Evidence for significant association between common sequence variants in CHRNB2 and nausea severity was obtained after adjusting for age, gender and correlated tests (all P(ACT)0.05). Individuals with the minor allele of CHRNB2 variants experienced less nausea than did those without the minor allele, consistent with previously reported findings for CHRNB2 and the occurrence of nausea and dizziness as a consequence of first smoking attempt in adolescents, and with the known neurophysiology of nausea. As nausea is the most common reason for discontinuance of varenicline, further pharmacogenetic investigations are warranted.