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To examine the effects of five intervention components on smokers’ adherence to combined nicotine patch and nicotine gum during a quit attempt and assess whether adherence is related to cessation. Smokers interested in quitting (N = 513; 59% female; 87% White) received nicotine patch plus nicotine gum and participated in a 2x2x2x2x2 randomized factorial experiment (i.e., 32 treatment conditions) evaluating five intervention components: (1) medication adherence counseling versus none; (2) automated medication adherence calls versus none; (3) electronic medication monitoring with feedback and counseling versus e-monitoring alone; (4) 26 versus 8 weeks of nicotine patch plus nicotine gum; and (5) maintenance counseling versus none. Adherence was assessed over the first 6 weeks post-target quit day via timeline follow-back (nicotine patch) and electronic medication dispenser (gum). In the first 6 weeks post-quit day, 12% of participants used no patches or gum, and 40% used the patch every day. Only 1.4% used both patch and gum adherently every day in the 6 weeks post-target quit day. E-monitoring counseling increased gum use (from 1.9 to 2.6 pieces/day; p

Extreme response style (ERS) has the potential to bias the measurement of intra-individual variability in psychological constructs (Baird, Lucas & Donnellan, 2017). This paper explores such bias through a multilevel extension of a latent trait model for modeling response styles applied to repeated measures rating scale data. Modeling responses to multi-item scales of positive and negative affect collected from smokers at clinic visits following a smoking cessation attempt revealed considerable ERS bias in the intra-individual sum score variances. In addition, simulation studies suggest the magnitude and direction of bias due to ERS is heavily dependent on the mean affect level, supporting a model-based approach to the study and control of ERS effects. Application of the proposed model-based adjustment is found to improve intra-individual variability as a predictor of smoking cessation.

Maternal smoking increases mortality and morbidity risks for both mother and infant. The First Breath Wisconsin study examined the cost-effectiveness of providing incentives to pregnant women who smoked to engage in stop smoking treatment. Participants (N = 1014) were Medicaid-enrolled pregnant women recruited from September 2012 to April 2015 through public health departments, private, and community health clinics in Wisconsin. The incentive group (n = 505) could receive $460 for completing pre-birth visits ($25 each), post-birth home visits ($40, $25, $25, $40 for 1-week, 2-month, 4-month and 6-month visits), monthly smoking cessation phone calls post-birth ($20 each), and biochemically-verified tobacco abstinence at 1-week ($40) and 6-months ($40) post-birth. The control group (n = 509) received up to $80 for 1-week ($40) and 6-month ($40) post-birth assessments. Intervention costs included incentive payments to participants, counselor and administrative staff time, and smoking cessation medications. Cost-effectiveness analysis calculated the incremental cost-effectiveness ratio (ICER) per one additional smoker who quit. The incentive group had higher 6-month post-birth biochemically-confirmed tobacco abstinence than the control group (14.7% vs. 9.2%). Incremental costs averaged $184 per participant for the incentive group compared to controls ($317 vs $133). The ICER of financial incentives was $3399 (95% CI $2228 to $8509) per additional woman who was tobacco abstinent at 6 months post-birth. The ICER was lower ($2518 vs $4760) for women who did not live with another smoker. This study shows use of financial incentives for stop smoking treatment is a cost-effective option for low-income pregnant women who smoke.

Smokers unwilling to make a quit attempt can still benefit from smoking intervention. However, it is unclear what proportion of smokers will enter such a Motivation phase intervention, and whether such an intervention attracts different types of smokers than does abstinence oriented treatment. We conducted a study from June 2010 to October 2013 based on a chronic care model of tobacco treatment among study eligible primary care patients (N=1579; 58% women, 89% White) presenting for regular health care visits in southern Wisconsin, U.S. Medical assistants, prompted via the electronic health record (EHR), invited smokers (n=10,242) to learn more about treatment options to help them either reduce their smoking or quit. Of those invited to learn more who were then reached by study staff, 10.2% (n = 1046) reported interest in reduction treatment and 24% (n = 2465) reported interest in cessation treatment. Patients who selected and ultimately entered reduction (n=492) versus cessation (n=1087) were more likely to report: older age; a history of anxiety; lower motivation to quit; lower primary dependence motives; more close friends or family who smoke; and a greater interval since their last quit attempt (ps

Importance Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures The primary outcome was carbon monoxide–confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17];P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, −0.4% [95% CI, −5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, −4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration. Trial Registration ClinicalTrials.gov Identifier:NCT03176784

Objective To understand the dynamic relations among tobacco withdrawal symptoms to inform the development of effective smoking cessation treatments. Dynamical system models from control engineering are introduced and utilized to evaluate complex treatment effects. We demonstrate how dynamical models can be used to examine how distinct withdrawal-related processes are related over time and how treatment influences these relations. Method Intensive longitudinal data from a randomized placebo-controlled smoking cessation trial (N = 1504) are used to estimate a dynamical model of withdrawal-related processes including momentary craving, negative affect, quitting self-efficacy, and cessation fatigue for each of six treatment conditions (nicotine patch, nicotine lozenge, bupropion, patch + lozenge, bupropion + lozenge, and placebo). Results Estimation and simulation results show that (1) withdrawal measurements are interrelated over time, (2) nicotine patch + nicotine lozenge showed reduced cessation fatigue and enhanced self-efficacy in the long-term while bupropion + nicotine lozenge was more effective at reducing negative affect and craving, and (3) although nicotine patch + nicotine lozenge had a better initial effect on cessation fatigue and self-efficacy, nicotine lozenge had a stronger effect on negative affect and nicotine patch had a stronger impact on craving. Conclusions This approach can be used to provide new evidence illustrating (a) the total impact of treatment conditions (via steady state values) and (b) the total initial impact (via rate of initial change values) on smoking-related outcomes for separate treatment conditions, noting that the conditions that produce the largest change may be different than the conditions that produce the fastest change.

Introduction Research shows that abstinence from tobacco leads to a withdrawal-related decrement in responsivity to nondrug rewards (ie, anhedonia). However, it remains unclear how anhedonia relates to other key withdrawal symptoms and withdrawal-related constructs over time. We analyzed ecological momentary assessment data to examine whether a decrement in response to rewards during a 10-day period following quitting shows a pattern of associations with other variables (ie, treatment, tobacco dependence, negative affect, and craving) that is consistent with anhedonia being a tobacco withdrawal symptom. Methods As part of a randomized controlled trial of smoking cessation therapies, 1122 adults (58% female) were assigned to: placebo (n = 131), bupropion (alone or with nicotine lozenge; n = 401), or nicotine replacement therapy (NRT; lozenge, patch, both; n = 590). Participants completed 4 ecological momentary assessments per day for 10 days postquit, resulting in 22 575 assessments. Results Time-varying effect modeling showed that anhedonia was significantly greater among those high in dependence relative to lower dependent smokers out to day 9 postquit. The placebo group showed elevated anhedonia immediately postquit, which fell to levels similar to the treatment groups by day 7. NRT effectively reduced anhedonia and its time-varying association with craving early in the quit attempt. The positive association between negative affect and anhedonia was moderate and stable over time for both active treatment groups. Conclusions These results provide additional support that anhedonia following quitting smoking is a manifestation of the tobacco withdrawal syndrome. Implications This study supported the hypothesis that diminished responsivity to nondrug rewards (ie, anhedonia) is a symptom of the tobacco withdrawal syndrome. Results showed that anhedonia: (1) was significantly associated with dependence, especially during the early postquit period when withdrawal was at its peak intensity; (2) showed significant time-varying associations with other withdrawal symptoms, especially craving; and (3) was significantly suppressed by agonist administration as was its association with craving over time.

A recently developed network perspective on tobacco withdrawal posits that withdrawal symptoms causally influence one another across time, rather than simply being indicators of a latent syndrome. Evidence supporting a network perspective would shift the focus of tobacco withdrawal research and intervention toward studying and treating individual withdrawal symptoms and inter-symptom associations. Yet, key questions remain to be addressed, including whether withdrawal symptoms and their interactions are moderated by abstinence and by cessation treatment. Here we examine the evidence for a network perspective on tobacco withdrawal. First, we use data from 668 participants (40% female, 78.29% African American) reporting on their experiences of withdrawal after 16 hours of smoking abstinence and during a non-abstinent state to examine the extent to which individual withdrawal symptoms are differentially impacted by smoking deprivation. Second, we estimate the symptom network structure of tobacco withdrawal during states of smoking satiety and abstinence. Third, we use experience-sampling data from 1210 participants (58.35% female, 86.24% white) undergoing smoking cessation treatment to estimate dynamic symptom networks that describe the interplay among withdrawal symptoms across time. Results indicate (i) differential impact of smoking deprivation on individual withdrawal symptoms, suggesting that symptoms are not interchangeable, (ii) substantial interplay among withdrawal symptoms that shows no evidence of change across periods of smoking satiety and abstinence, and (iii) reductions in the interplay among withdrawal symptoms during smoking cessation treatment. Overall, findings suggest the utility of a network perspective and encourage a greater consideration of the individual symptoms of tobacco withdrawal.

BACKGROUND AND OBJECTIVES: Negative consequences of tobacco use during cancer treatment are well-documented but more in-depth, patient-level data are needed to understand patient beliefs about continued smoking (versus cessation) during gastrointestinal (GI) cancer treatment. METHODS: We conducted semi-structured interviews with 10 patients who were active smokers being treated for GI cancers and 5 caregivers of such patients. All interviews were audio-recorded, transcribed verbatim, and uploaded to NVivo. We consensus coded data inductively using conventional content analysis and iteratively developed our codebook. We developed data matrices to categorize the themes regarding patient perspectives on smoking as well as presumed barriers to smoking cessation during active therapy. RESULTS: Our interviews revealed three consistent themes: (1) Smoking cessation is not necessarily desired by many patients who have received a cancer diagnosis; (2) Failure in past quit attempts may lead to feelings of hopeless about future attempts, especially during cancer treatment; (3) Patients perceived little to no access to smoking cessation treatment at the time of their cancer diagnosis. CONCLUSIONS: Well-designed systemic changes that promote the positive and efficacious effects of quitting smoking during cancer treatment, and that provide barrier-free access to such treatments may be helpful in promoting tobacco-free behavior during cancer treatment.

BackgroundChanges in tobacco products, use patterns, and assessment technology in the last 15 years led the Society for Research on Nicotine and Tobacco (SRNT) Treatment Research Network to call for an update to the 2003 SRNT recommendations for assessing abstinence in clinical trials of smoking cessation interventions.MethodsThe SRNT Treatment Research Network convened a group of investigators with decades of experience in conducting tobacco treatment clinical trials. To arrive at the updated recommendations, the authors reviewed the recommendations of the prior SRNT Workgroup as well as current literature. Ten additional experts in the field provided feedback on this paper and these recommendations.ResultsWith respect to defining abstinence, the authors recommend: (1) continuing to use the definition of no use of combustible tobacco products (regardless of use of noncombustible tobacco products [e.g., snus] and alternative products [e.g., e-cigarettes]) and collecting additional data to permit alternate abstinence definitions; (2) no use of combustible or smokeless tobacco products; and (3) no use of combustible or smokeless tobacco products or alternative products, as appropriate for the research question being addressed. The authors also recommend reporting point prevalence and prolonged abstinence at multiple timepoints (end of treatment, ≥3 months after the end of treatment, and ≥6 months postquit or posttreatment initiation).ConclusionsDefining abstinence requires specification of which products a user must abstain from using, the type of abstinence (i.e., point prevalence or continuous), and the duration of abstinence. These recommendations are intended to serve as guidelines for investigators as they collect the necessary data to accurately describe participants’ abstinence during smoking cessation clinical trials.ImplicationsThis paper provides updated recommendations for defining abstinence in the context of smoking cessation treatment clinical trials.

Background Nonadherence to smoking cessation medication is a frequent problem. Identifying pre-quit predictors of nonadherence may help explain nonadherence and suggest tailored interventions to address it. Aims Identify and characterize subgroups of smokers based on adherence to nicotine replacement therapy (NRT). Method Secondary classification tree analyses of data from a 2-arm randomized controlled trial of Recommended Usual Care (R-UC, n = 315) versus Abstinence-Optimized Treatment (A-OT, n = 308) were conducted. R-UC comprised 8 weeks of nicotine patch plus brief counseling whereas A-OT comprised 3 weeks of pre-quit mini-lozenges, 26 weeks of nicotine patch plus mini-lozenges, 11 counseling contacts, and 7–11 automated reminders to use medication. Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges. Results Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use. Greater quitting motivation and confidence, and believing that stop smoking medication was safe and easy to use were associated with greater adherence. Conclusion Adherence was especially high in those who were more dependent and more exposed to smoking triggers. Quitting motivation and confidence predicted greater adherence, while negative beliefs about medication safety and acceptability predicted worse adherence. Results suggest that adherent use of medication may reflect a rational appraisal of the likelihood that one will need medication and will benefit from it.

Background Dual use of combustible and electronic cigarettes (e-cigarettes) is a growing use pattern; more than half of e-cigarette users are dual users. However, little is known regarding the course of dual use; for example, the likelihood of discontinuation of either combustible or e-cigarettes or both. Methods Adult daily smokers and dual users (daily smokers who also vaped at least once per week) who did not intend to quit use of either product in the next 30 days participated in a longitudinal, observational study (N = 322, 51.2% women, 62.7% white, mean age = 42.27 [SD = 14.05]). At baseline, participants completed demographics and smoking and vaping history assessments. They also reported daily cigarette and e-cigarette use via timeline follow-back assessment and provided a breath sample for carbon monoxide assay at 4-month intervals for 1 year. Results Of those who completed the year 1 follow-up, 1.9% baseline smokers and 8.0% dual users achieved biochemically confirmed seven-day point-prevalence abstinence from combustible cigarettes (χ2 = 4.57, p = .03). Of initial dual users, by 1 year 43.9% were smoking only, 48.8% continued dual use, 5.9% were vaping only, and 1.4% abstained from both products. Among baseline smokers, 92.3% continued as exclusive smokers. Baseline dual users who continued e-cigarette use were more likely to be white and report higher baseline e-cigarette dependence. Conclusions In this community sample, the majority of dual users transitioned to exclusive smoking. A higher percentage of dual users quit smoking than smokers, but attrition and baseline differences between the groups compromise strong conclusions. Sustained e-cigarette use was related to baseline e-cigarette dependence. Implications This research suggests that dual use of combustible and e-cigarettes is not a sustained pattern for the majority of dual users, but it is more likely to be a continued pattern if the user is more dependent on e-cigarettes. There was evidence that dual users were more likely to quit smoking than exclusive smokers, but this may be due to factors other than their dual use.

BackgroundThe changing prevalence and patterns of tobacco use, the advent of novel nicotine delivery devices, and the development of new biomarkers prompted an update of the 2002 Society for Research on Nicotine and Tobacco (SRNT) report on whether and how to apply biomarker verification for tobacco use and abstinence.MethodsThe SRNT Treatment Research Network convened a group of investigators with expertise in tobacco biomarkers to update the recommendations of the 2002 SNRT Biochemical Verification Report.ResultsBiochemical verification of tobacco use and abstinence increases scientific rigor and is recommended in clinical trials of smoking cessation, when feasible. Sources, appropriate biospecimens, cutpoints, time of detection windows and analytic methods for carbon monoxide, cotinine (including over the counter tests), total nicotine equivalents, minor tobacco alkaloids, and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol are reviewed, as well as biochemical approaches to distinguishing cigarette smoking from use of electronic nicotine delivery devices (ENDS).ConclusionsRecommendations are provided for whether and how to use biochemical verification of tobacco use and abstinence. Guidelines are provided on which biomarkers to use, which biospecimens to use, optimal cutpoints, time windows to detection, and methodology for biochemical verifications. Use of combinations of biomarkers is recommended for assessment of ENDS use.ImplicationsBiochemical verification increases scientific rigor, but there are drawbacks that need to be assessed to determine whether the benefits of biochemical verification outweigh the costs, including the cost of the assays, the feasibility of sample collection, the ability to draw clear conclusions based on the duration of abstinence, and the variability of the assay within the study population. This paper provides updated recommendations from the 2002 SRNT report on whether and how to use biochemical markers in determining tobacco use and abstinence.

Aims To (1) identify distinct classes of smokers based on quit day withdrawal symptoms and (2) explore the relations between withdrawal classes and demographics, tobacco dependence, treatment and smoking outcomes. Design Secondary data analysis of participants (n = 1504) in a randomized double-blind placebo-controlled multi-site smoking cessation trial who provided ecological momentary assessments of withdrawal symptoms on their quit day. Participants received smoking cessation counseling and were randomized to receive placebo or one of five active pharmacotherapies. Setting Research offices in Madison and Milwaukee, Wisconsin, USA. Participants Adult smokers (n = 1236; 58% female, 86% white), recruited from the community via advertisements, who abstained on their quit day. Measurements Demographics and tobacco dependence were assessed at baseline and participants carried palmtop computers to record withdrawal symptoms (craving, negative affect, difficulty concentrating, hunger and anhedonia) on their quit day. Point-prevalence abstinence and latency to relapse were assessed at 8 weeks and 6 months post-quit. Findings Latent class analysis identified four withdrawal classes [Akaike information criterion (AIC) = 70.09]: Moderate withdrawal (64% of sample), high craving–anhedonia (8% of sample), affective withdrawal (13% of sample) and hunger (15% of sample). The high craving–anhedonia class reported significantly higher dependence (P

UNLABELLED Smoking affects comorbid disease outcomes, and patients with comorbid conditions may have unique characteristics that are important to consider when treating tobacco use. However, addressing tobacco in patients being treated for comorbid conditions is not a consistent practice. Recognizing the need for a "call-to-action" to address tobacco use in people with comorbid conditions, the Tobacco Treatment Network within the Society for Research on Nicotine and Tobacco (SRNT) convened a Comorbidities Workgroup to explore the relationship between smoking and comorbid disease to identify common themes including: the harms associated with continued tobacco use, the frequency of comorbid disease and tobacco use, the potential effect of comorbid disease on the ability to quit tobacco use, the association between tobacco use and suboptimal disease-specific treatment response, and evidence regarding potential approaches to improve addressing tobacco use in patients with comorbid disease. Five candidate conditions (psychiatric, cancer, cardiovascular, pulmonary, and human immunodeficiency virus infected patients) were explored. Across comorbid conditions, smoking adversely affects treatment efficacy and promotes other adverse health conditions. People with comorbid conditions who smoke are motivated to quit and respond to evidence-based smoking cessation treatments. However, tobacco cessation is not regularly incorporated into the clinical care of many individuals with comorbidities. Optimal strategies for addressing tobacco use within each comorbid disease are also not well defined. Further work is needed to disseminate evidence-based care into clinical practice for smokers with comorbid disease and addiction research should consider comorbid conditions as an important construct to explore. IMPLICATIONS This article explores how physical and psychiatric conditions may interact in the treatment of tobacco dependence, and discusses the need for smoking cessation as a critical component of comorbid condition management. Five common comorbid domains-psychiatric, cancer, pulmonary, cardiovascular, and human immunodeficiency virus (HIV)-are highlighted to illustrate how these different conditions might interact with smoking with respect to prevalence and harm, motivation to quit, and cessation treatment utilization and success.

In this placebo-controlled randomized clinical trial, we examined the efficacy of 250 mg d-cycloserine (DCS) for enhancing the effects of cognitive behavior therapy targeting anxiety sensitivity reduction in the context of smoking cessation treatment among adults with a history of panic attacks. We hypothesized that DCS would enhance treatment of our mechanistic targets-anxiety sensitivity and panic and related symptoms-and result in greater smoking abstinence. A total of 53 smokers were randomized to a 7-week integrated treatment and received study medication (DCS or placebo) prior to sessions 3-5; these sessions emphasized interoceptive exposure practice. Nicotine replacement therapy was initiated at session 5 (quit date). We found that DCS augmentation led to greater reductions of one (anxiety sensitivity) of two of our mechanistic targets at early but not late assessments, and that engaging that target predicted better smoking outcomes. However, there was no evidence of group (DCS vs. placebo) differences in smoking cessation success at treatment endpoint or follow-up evaluations. Hence, although we found that DCS can enhance treatment targeting a smoking maintaining factor, additional strategies appear to be needed to significantly affect smoking outcomes.

Introduction This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. Methods Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. Results DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. Conclusions DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. Implications People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. Trial Registration NCT01553084.

INTRODUCTION: The progress achieved in reducing tobacco use has not been consistent across groups of smokers, and health systems are inconsistently implementing best practice guidelines. Guideline implementation could be associated with improved treatment invitation rates. AIMS: To evaluate differences in tobacco treatment invitation rates based on patient characteristics in primary care clinics implementing best practice guidelines. METHODS: A secondary analysis of patients presenting to 11 primary care clinics from two Wisconsin health systems from June 2010 to February 2013. The main outcome was whether patients received an invitation to participate in tobacco treatment. Invitation rates were examined by: gender, age group (64), race (white, African American, other), insurance status (private, Medicare, Medicaid, none), and visit diagnosis (“high-risk” [cardiovascular and pulmonary disease, malignancy, pregnancy] versus “low-risk” [all other ICD-9 categories]). Moderation effects of health systems were also examined. RESULTS: Of the 95,471 patients seen, 84,668 (89%) were screened for smoking. Among the 15,193 smokers, 10,242 (67%) were invited to participate. Invited patients were older, white or African American, and carried low-risk diagnoses. Invitation rates and patient-level differences varied between the health systems. CONCLUSIONS: Variable treatment invitation rates and health system differences remain evident in the primary care setting employing robust Clinical Practice Guideline recommendations.

IMPORTANCE: Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States and worldwide, and most tobacco users begin smoking in adolescence. Although advances have yielded efficacious pharmacotherapies to complement smoking cessation counseling in adults, far less progress has been made in addressing tobacco use in adolescence. OBJECTIVE: To evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults. DESIGN, SETTING, AND PARTICIPANTS: This 2-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of treatment-seeking adolescent and young adult cigarette smokers (n = 157) aged 14 to 21 years at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up was completed on January 25, 2018. Data were analyzed from March 19, 2018, to August 11, 2018, with further revisions completed April 10, 2019. INTERVENTIONS: Participants were randomized in a 1:1 ratio to a 12-week course of varenicline (n = 77) or placebo (n = 80). All participants received weekly smoking cessation counseling. MAIN OUTCOMES AND MEASURES: The preselected primary efficacy outcome was urine cotinine level–confirmed 7-day abstinence at the end of treatment. Secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. The primary safety outcome was the frequency of treatment-emergent adverse events. RESULTS: A total of 157 participants were enrolled (94 male [59.9%]; mean [SD] age, 19.1 [1.5] years). The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96). However, among secondary outcomes, the varenicline group achieved self-reported earlier abstinence of at least 7 days (hazard ratio, 1.91; 95% CI, 1.12-3.27) and demonstrated higher rates of self-reported weekly abstinence during the full course of treatment (RR, 1.81; 95% CI, 1.09-2.99; P = .02) and at posttreatment follow-up (RR, 1.82; 95% CI, 1.01-3.28; P = .02). Study medication was generally well tolerated, and treatment-emergent adverse events did not differ between groups (any adverse events, 55 [71.4%] in the varenicline group vs 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61). CONCLUSIONS AND RELEVANCE: When added to weekly cessation counseling for adolescent cigarette smokers, varenicline, compared with placebo, was well tolerated but did not improve end-of-treatment abstinence. However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01509547

This pilot study evaluated associations between carotid wall echogenicity, cardiovascular disease (CVD) risk factors, and three markers of smoking heaviness in a cohort of active smokers. Common carotid artery (CCA) gray-scale median (GSM) values were measured from sonographic images. Univariable correlations and exploratory multivariable models were used to determine associations between CCA GSM, CVD risk factors, and measures of smoking heaviness. CCA GSM was measured in 162 smokers and was correlated inversely with cigarettes smoked/d (r = −0.16, P = .048); pack-years (r = −0.204, P = .009); CVD risk factors such as age, male sex, waist circumference, and low-density lipoprotein cholesterol (all P ≤ .03); and positively with high-density lipoprotein cholesterol ( P < .001). Associations between CCA GSM and smoking heaviness markers were not statistically significant after adjustment for traditional risk factors. The results from this pilot study demonstrate the feasibility of measuring the GSM value of the CCA far wall and its association with measures of smoking heaviness and traditional CVD risk factors among current smokers.

Objective Although smoking is a risk factor for cardiovascular and rheumatic disease severity, only 10% of rheumatology visits document cessation counseling. After implementing a rheumatology clinic protocol that increased tobacco quitline referrals 20-fold, we undertook this study to examine patients' barriers and facilitators to smoking cessation based on prior rheumatology experiences, to solicit reactions to the new cessation protocol, and to identify patient-centered outcomes or signs of cessation progress following improved care. Methods We recruited 19 patients who smoke (12 with rheumatoid arthritis [RA] and 7 with systemic lupus erythematosus [SLE]) to participate in 1 of 3 semistructured focus groups. Transcripts of the focus group discussions were analyzed using thematic analysis to classify barriers, facilitators, and signs of cessation progress. Results Participant-reported barriers and facilitators to cessation involved psychological, health-related, and social and economic factors, as well as health care messaging and resources. Commonly discussed barriers included viewing smoking as a crutch amid rheumatic disease, rarely receiving cessation counseling in rheumatology clinics, and very limited awareness that smoking can worsen rheumatic diseases or reduce efficacy of some rheumatic disease medications. Participants endorsed our cessation protocol with rheumatology-specific education and accessible resources, such as a quitline. Beyond quitting, participants prioritized knowing why and how to quit as signs of progress outcomes. Conclusion Focus groups identified themes and categories of facilitators/barriers to smoking cessation at the levels of patient and health system. Two key outcomes of improving cessation care for patients with RA and SLE were knowing why and how to quit. Emphasizing rheumatologic health benefits and cessation resources is essential when designing and evaluating rheumatology smoking cessation interventions.

Background The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO

Background Existing longitudinal surveys focused on the association between ever use of e-cigarettes and combustible cigarette consumption, making it difficult to infer what characteristics of e-cigarette use could potentially change combustible cigarette use behavior, which may have long-term health consequences. Although e-cigarettes' efficacy of alleviating dependence symptoms was supported by studies conducted in laboratory settings, whether the results can be translated into symptom reduction in the real world and over time is an open question. Methods This study conducted secondary analysis on the Waves 1-2 data of the Population Assessment of Tobacco and Health (PATH) Study to examine the association between e-cigarette use characteristics (frequency, flavoring, and voltage adjustment) and combustible cigarette use outcomes (frequency, quantity, and symptoms), using the Heckman 2-step selection procedure with the selection bias controlled. The inclusion criteria ensured that we followed an adult cohort of exclusive combustible cigarette users at Wave 1. Results The result shows that higher frequency of e-cigarette use was associated with lower combustible cigarette consumption and dependence symptoms, controlling for the corresponding baseline cigarette use variable and other confounders. Given the frequency of e-cigarette use, the feature of voltage adjustment was not significantly associated with any of the cigarette use outcomes. Flavoring, on the other hand, was associated with lower quantity of cigarette use. Conclusions Exclusive smokers who start using e-cigarettes do indeed change the frequency and quantity with which they smoke cigarettes. E-cigarette use may also help reduce dependence symptoms.

Social relationships play an important role in the uptake, maintenance, and cessation of smoking behavior. However, little is known about the natural co-occurrence of social network features in adult smokers' networks and how multidimensional features of the network may connect to abstinence outcomes. The current investigation examined whether qualitatively distinct subgroups defined by multiple characteristics of the social network could be empirically identified within a sample of smokers initiating a quit attempt. Egocentric social network data were collected from 1571 smokers (58% female, 83% white) engaged in a 3-year smoking cessation clinical trial. Using nine indicator variables reflecting both risk and protective network features, finite mixture models identified five social network subgroups: High Stress/High Contact, Large and Supportive, Socially Disconnected, Risky Friends and Low Contact, and High Contact with Smokers and Light Drinkers. External variables supported the validity of the identified subgroups and the subgroups were meaningfully associated with baseline demographic, psychiatric, and tobacco measures. The Socially Disconnected subgroup was characterized by little social interaction, low levels of stress, and low exposure to social environmental smoking cues, and had the highest probability of successful cessation at 1 week compared with all other social network subgroups. At 6 months posttreatment its members had higher abstinence rates than members of the High Stress/High Contact subgroup and the Risky Friends and Low Contact subgroup. The present study highlights the heterogeneity of smokers' social milieus and suggests that network features, especially those entailing exposure to smoking cues and contexts, heighten risk for smoking cessation failure. (PsycINFO Database Record

Background and aims A chronic care strategy could potentially enhance the reach and effectiveness of smoking treatment by providing effective interventions for all smokers, including those who are initially unwilling to quit. This paper describes the conceptual bases of a National Cancer Institute-funded research program designed to develop an optimized, comprehensive, chronic care smoking treatment. Methods This research is grounded in three methodological approaches: (1) the Phase-Based Model, which guides the selection of intervention components to be experimentally evaluated for the different phases of smoking treatment (motivation, preparation, cessation, and maintenance); (2) the Multiphase Optimization Strategy (MOST), which guides the screening of intervention components via efficient experimental designs and, ultimately, the assembly of promising components into an optimized treatment package; and (3) pragmatic research methods, such as electronic health record recruitment, that facilitate the efficient translation of research findings into clinical practice. Using this foundation and working in primary care clinics, we conducted three factorial experiments (reported in three accompanying papers) to screen 15 motivation, preparation, cessation and maintenance phase intervention components for possible inclusion in a chronic care smoking treatment program. Results This research identified intervention components with relatively strong evidence of effectiveness at particular phases of smoking treatment and it demonstrated the efficiency of the MOST approach in terms both of the number of intervention components tested and of the richness of the information yielded. Conclusions A new, synthesized research approach efficiently evaluates multiple intervention components to identify promising components for every phase of smoking treatment. Many intervention components interact with one another, supporting the use of factorial experiments in smoking treatment development.

Aims To identify promising intervention components intended to help smokers to attain and maintain abstinence in their quit smoking attempts. Design A fully crossed, six-factor randomized fractional factorial experiment. Setting Eleven primary care clinics in southern Wisconsin, USA. Participants A total of 637 adult smokers (55% women, 88% white) motivated to quit smoking who visited primary care clinics. Interventions Six intervention components designed to prepare smokers to quit, and achieve and maintain abstinence (i.e. for the preparation, cessation and maintenance phases of smoking treatment): (1) preparation nicotine patch versus none; (2) preparation nicotine gum versus none; (3) preparation counseling versus none; (4) intensive cessation in-person counseling versus minimal; (5) intensive cessation telephone counseling versus minimal; and (6) 16 versus 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine gum). Measurements Seven-day self-reported point-prevalence abstinence at 16 weeks. Findings Preparation counseling significantly improved week 16 abstinence rates (P = .04), while both forms of preparation nicotine replacement therapy interacted synergistically with intensive cessation in-person counseling (P

Aims To identify promising intervention components that help smokers attain and maintain abstinence during a quit attempt.Design A2×2×2×2×2randomizedfactorialexperiment.Setting ElevenprimarycareclinicsinWisconsin, USA. Participants A total of 544 smokers (59% women, 86% white) recruited during primarycare visits and motivated to quit. Interventions Five intervention components designed to help smokers attain and maintain abstinence: (1) extended medication (26 versus 8 weeks of nicotine patch+nicotine gum); (2) maintenance (phone) counseling versus none; (3) medication adherence counseling versus none; (4) automated (medication) adherence calls versus none; and (5) electronic medication monitoring with feedback and counseling versus electronic medication monitoring alone. Measurements The primary outcome was 7-day self-reported point-prevalence abstinence 1 year after the target quit day. Findings Only extended medication produced a main effect. Twenty-six versus 8 weeks of medication improved point-prevalence abstinence rates (43 versus 34% at 6 months; 34 versus 27% at 1 year; P =0.01 for both). There were four interaction effects at 1 year, showing that an intervention component’s effectiveness depended upon the components with which it was combined. Conclusions Twenty-six weeks of nicotine patch+nicotine gum (versus 8 weeks) and maintenance counseling provided by phone are promising intervention components for the cessation and maintenance phases of smoking treatment.

Background: A smoke-free home rule has been associated with reduced cigarette consumption; however, it is unknown whether a home rule is associated with the use of alternative tobacco products (ATP) such as smokeless tobacco products, regular and water pipes, and cigars. This study examined the association between the smoke-free home rules and ever and current use of ATP. Method: Data from the 2010–2011 US Tobacco Use Supplements to the Current Population Survey were analysed using multivariable logistic regressions, including variables related to smoke-free home rules. Results: Overall, 83.9% respondents reported a smoke-free home rule inside their homes; 20.6% of respondents had tried at least one type of ATP, and 3.9% were current users in 2010–2011. Having a smoke-free home rule was associated with lower likelihood of current versus never use of any ATP (adjusted odds ratio (AOR) = 0.80, 95% confidence interval (CI): 0.77–0.83). Among ever users of any ATP, the existence of a smoke-free home rule was associated with lower odds of being a current user (AOR = 0.49, 95% CI: 0.43–0.56). Similar associations were observed for each type of ATP examined (p Conclusion: Smoke-free home rules are associated with lower current ATP use among the US population. Future research should examine whether promoting smoke-free home rules could help to reduce ATP use and related diseases.

Animal research suggests that anhedonia is a tobacco withdrawal symptom, but this topic has not been addressed definitively in research with humans. This research sought to determine whether anhedonia is (a) an element of the tobacco withdrawal syndrome in humans and (b) an impediment to successful tobacco cessation. Data were from 1,175 smokers (58.3% women; 85.5% White) participating in a randomized double-blind, placebo-controlled trial of smoking cessation pharmacotherapies. Ecological momentary assessments for 5 days before and 10 days after the target quit day were used to assess anhedonia and other established withdrawal symptoms. Consistent with drug withdrawal, anhedonia showed an inverted-U pattern of change in response to tobacco cessation and was associated with the severity of other withdrawal symptoms and tobacco dependence. Postquit anhedonia was associated with decreased latency to relapse (hazard ratio = 1.09, 95% confidence interval [CI] [1.02, 1.17]) and with lower 8-week point-prevalence abstinence (odds ratio = .91, 95% CI [.86, .97])-relations that remained significant when other withdrawal symptoms were included as predictors. Finally, nicotine replacement therapy nearly fully suppressed the increase in abstinence-related anhedonia (β = -.66, p < .001), suggesting agonist suppression of withdrawal. Results suggest that anhedonia is a unique and motivationally significant element of the tobacco withdrawal syndrome in humans. These results have implications for defining and assessing tobacco use disorder and for understanding and treating tobacco addiction.

Most smokers attempting to quit will relapse, even when using evidence-based cessation treatment. This illustrates the need for better understanding of the relapse process to thereby improve cessation treatments. While the impact of stress sensitivity on relapse is clear, little research has precisely examined stress reactivity in addicted individuals. Further, most research on relapse focuses on affect surrounding self-administration, and doesn't address potentially important pre-consumption processes such as anticipation of use. We examined the effects of anticipation and actual smoking on stress reactivity in 34 deprived smokers withdrawn for 24 hours and 37 non-deprived smokers, with 37 non-smoker controls. Using a cued shock stressor task, we measured stress reactivity via startle potentiation and self-reported anxiety. After completing the task once, smokers anticipated smoking a cigarette resting in front of them while they completed the task a second time. Smokers then smoked before completing the task a third and final time. Non-smokers anticipated and drank water as a control. Anticipation of smoking significantly attenuated both startle potentiation and self-reported anxiety to shock cues for deprived smokers relative to non-deprived smokers. Smokers' stress reactivity was not reduced by smoking beyond the prior effect of anticipation. These results suggest that anticipation, rather than actual drug consumption, may drive the primary reinforcing effect of reduced stress reactivity in smoking. Future research is needed to understand this effect of anticipation on drug use and determine whether anticipation would make an effective intervention target for addiction and other psychopathology which exhibits increased stress sensitivity.

Although endogenous sex hormones influence smoking-related outcomes, little is known about the effect of exogenous sex hormones. Therefore, the goal of this preliminary study was to examine differences in withdrawal symptoms and cessation between women using hormonal contraceptives (HC), women not using hormonal contraceptives (no-HC) and men. Utilizing data from two recently completed smoking cessation randomized clinical trials, we selected participants who were between the ages of 18-35years old. Participants were classified based on use of hormonal contraceptives and gender, then matched based on pharmacotherapy randomization assignment and baseline cigarettes per day. Participants provided self-reported assessments on withdrawal, craving and negative affect, and smoking status was assessed for 52weeks after quit date. Participants (N=130) were 28.7±0.4years old and smoked 16.8±0.6 cigarettes/day. Compared to both no-HC and men, the HC group had significantly greater withdrawal one week prior to the quit date, on the quit date and one week after the quit date. During the first week of attempted abstinence, craving declined in HC and in men, but increased in no-HC. At end of treatment, the HC group was at 3.73 times higher odds of being abstinent compared to men (95% confidence interval: 1.12-12.40). There were no group differences in abstinence rates at Week 26 or 52. These data suggest that HC users may experience more adverse levels of withdrawal, though may be more likely to achieve short-term abstinence. Future research is needed to replicate our observations and explore mechanisms of action.

Efficient new technology has made it straightforward for behavioral scientists to collect anywhere from several dozen to several thousand dense, repeated measurements on one or more time-varying variables. These intensive longitudinal data (ILD) are ideal for examining complex change over time, but present new challenges that illustrate the need for more advanced analytic methods. For example, in ILD the temporal spacing of observations may be irregular, and individuals may be sampled at different times. Also, it is important to assess both how the outcome changes over time and the variation between participants' time-varying processes to make inferences about a particular intervention's effectiveness within the population of interest. The methods presented in this article integrate two innovative ILD analytic techniques: functional data analysis and dynamical systems modeling. An empirical application is presented using data from a smoking cessation clinical trial. Study participants provided 42 daily assessments of pre-quit and post-quit withdrawal symptoms. Regression splines were used to approximate smooth functions of craving and negative affect and to estimate the variables' derivatives for each participant. We then modeled the dynamics of nicotine craving using standard input-output dynamical systems models. These models provide a more detailed characterization of the post-quit craving process than do traditional longitudinal models, including information regarding the type, magnitude, and speed of the response to an input. The results, in conjunction with standard engineering control theory techniques, could potentially be used by tobacco researchers to develop a more effective smoking intervention.

Introduction Researchers have increasingly begun to gather ecological momentary assessment (EMA) data on smoking, but new statistical methods are necessary to fully unlock information from such data. In this paper, we use a new technique, the logistic time-varying effect model (logistic TVEM), to examine the odds of smoking in the 2 weeks after a quit attempt. Methods Data are from a subsample of participants from a randomized, placebo-controlled trial of smoking cessation pharmacotherapies who achieved initial abstinence (N = 1,106, 58% female). Participants completed up to 4 EMA assessments per day during the 2 weeks after their quit day. Predictors include baseline nicotine dependence, EMA measures of craving and negative affect, and whether an individual was assigned to a placebo, monotherapy, or combination therapy condition. Time-varying effects of these predictors were estimated using logistic TVEM. Results Cravings were a significant predictor of smoking throughout the entire 2 weeks postquit, whereas the effect of baseline dependence became nonsignificant by the second week, and the effect of negative affect increased over time. Individuals in the monotherapy and combination therapy conditions had decreased odds of smoking compared with placebo in the first week postquit, but these differences were nonsignificant in the second week. Conclusions Findings suggest that pharmacotherapies are more effective compared with placebo earlier in a quit attempt, when the effect of baseline nicotine dependence on smoking is stronger, whereas the effect of craving and negative affect increased over time. Future cessation therapies may be more successful by providing additional support in the second week after quit attempt.

Cigarette smoking is a major global public health issue and the leading cause of preventable death in the United States. Toward a goal of designing better smoking cessation treatments, system identification techniques are applied to intervention data to describe smoking cessation as a process of behaviour change. System identification problems that draw from two modelling paradigms in quantitative psychology (statistical mediation and self-regulation) are considered, consisting of a series of continuous-time estimation problems. A continuous-time dynamic modelling approach is employed to describe the response of craving and smoking rates during a quit attempt, as captured in data from a smoking cessation clinical trial. The use of continuous-time models provide benefits of parsimony, ease of interpretation, and the opportunity to work with uneven or missing data.

The relation between lifetime depression and smoking cessation outcome has been extensively studied, but remains poorly understood. One important barrier to understanding this association is that important sources of variation within depression may alter how depression confers risk of smoking relapse. Indeed, a recent meta-analytic study showed a modest but statistically significant overall relation between pre-quit lifetime depression status and post-quit relapse risk (Hitsman et al., 2013), but also identified several moderators of this relation, including recency of depression, type of depression measure, and other factors (Hitsman et al., 2013). Other research that indicates that recurrence is another important source of heterogeneity, as recurrent (vs. single episode) forms of lifetime depression predict poorer cessation outcome (Brown et al., 2001; Haas, Munoz, Humfleet, Reus, & Hall, 2004). One important, yet often overlooked, issue is depression's symptomatic heterogeneity. Depression comprises a diverse array of symptoms spanning affective (e.g., sadness), behavioral (e.g., psychomotor changes), cognitive (e.g., concentration problems), and vegetative (e.g., sleep and appetite disruption) features that loosely cluster together (Zimmerman, McGlinchey, Young, & Chelminski, 2006). Given the diversity of depressive symptoms, is possible that only certain symptomatic expressions of depression increase risk of relapse, whereas others are relatively benign with regard to smoking cessation. Thus, combining all symptoms of depression into a single diagnostic category may increase error and obscure important variability in relapse risk within the population of smokers with lifetime depressive symptoms and syndromes. Anhedonia (i.e., diminished interest or pleasure in normally enjoyable activities) and depressed mood (i.e., elevated sadness) constitute the two hallmark features of depression (APA, 1994). Either anhedonia or depressed mood is required (in addition to at least four other symptoms) to qualify for a DSM-IV major depression diagnosis (APA, 1994). Although they are both key symptoms of the same syndrome (i.e., depression), anhedonia and depressed mood are empirically distinct (Zimmerman et al., 2006; i.e., anhedonia commonly occurs without concurrent depressed mood and depresssed mood occurs without concurrent anhedoina), have unique neural correlates (Wacker, Dillon, & Pizzagalli, 2009), and are putatively distinct depressive endophenotypes (Hasler, Drevets, Manji, & Charney, 2004). Research suggests that these two facets of depression are particularly relevant for smoking cessation because they both appear to impact smoking motivation and do so via discrete mechanisms. There is copious evidence that negative affect states, including sadness, influences smoking motivation (Baker, Piper, McCarthy, Majeskie, & Fiore, 2004; Falcone et al., 2012; Leventhal et al., 2013; Litvin & Brandon, 2010). Further, trait depressed mood and negative affect predict greater exacerbations in state negative affect and urge to smoke for negative affect relief upon tobacco abstinence (Gilbert et al., 1998; Leventhal et al., 2013). Anhedonia is also associated with smoking motivation and some research suggests that anhedonic individuals smoke in order to enhance the ability to enjoy activities and experience pleasure (Cook, Spring, & McChargue, 2007; Leventhal, Waters, Kahler, Ray, & Sussman, 2009). Furthermore, anhedonia predicts declines in state positive affect as well as increases in urge to smoke for pleasure upon tobacco abstinence (Cook, Spring, McChargue, & Hedeker, 2004; Leventhal, Ameringer, Osborne, Zvolensky, & Langdon, in press; Leventhal et al., 2009). Thus, the overarching depression construct could heighten risk of cessation failure via two distinct contingencies: (1) omission training whereby abstinence produces deficits in positive affect in anhedonic individuals, which results in a “time out” from reward and strong drive to re-attain smoking-mediated reward, and/or (2) negative reinforcement in which smokers with depressed mood become hyper motivated to escape the distress (negative affect) of withdrawal. Despite the putatively important roles of anhedonia and depressed mood in smoking, empirical data on the relative risk of smoking relapse conferred by lifetime anhedonia and depressed mood is lacking. Yet, distilling the elements of depression that most powerfully predict smoking cessation failure could: (1) elucidate the motivational processes that maintain addiction, (2) meaningfully increase the prediction of cessation failure by reducing error in the predictor, and (3) suggest new relapse prevention interventions that address the core elements of depression-related vulnerability. The current study addresses two critical questions in an effort to distill the depression phenotype as it is related to risk of cessation failure. Does lifetime anhedonia or depressed mood (irrespective of whether they occur in conjunction with a clinical depressive disorder) predict cessation outcomes? Do both types of affective symptoms make independent, additive contributions to prediction, or is one symptom prepotent in accounting for the relation? We focuses on affective as opposed to other types of depressive symptoms because prior cessation research using paper-and-pencil symptom indices illustrate that anhedonia and depressed mood predict poor cessation outcomes (Cook, Spring, McChargue, & Doran, 2010; Leventhal, Ramsey, Brown, LaChance, & Kahler, 2008; Niaura et al., 2001; c.f., Schnoll, Leone, & Hitsman, 2013), whereas non-affective dimensions of depression (e.g., somatic features manifested as sleep problems, appetite changes, concentration problems, and psychomotor slowing) do not directly or incrementally augment such predictions (Leventhal et al., 2008; Schnoll et al., 2013). Similarly, tobacco withdrawal research demonstrates that affective withdrawal symptoms predict cessation failure more consistently than non-affective withdrawal symptoms (McCarthy, Piasecki, Fiore, & Baker, 2006; Piasecki et al., 2000). Thus, affective features may perhaps capture relatively pure facets of depression that directly magnify smoking motivation during a quit attempt. We hypothesized that lifetime history of anhedonia and depressed mood would predict poorer cessation outcomes over and above lifetime DSM-IV classified depressive disorder, which represents an amalgam of cognitive, behavioral, and vegetative features. Given that anhedonia and depressed mood might impede smoking cessation through distinct affective mechanisms (i.e., reward enhancement vs. distress relief), we further hypothesized that these two features would yield additive predictive effects. This research will address these hypotheses using DSM-based interview assessment of anhedonia and depressed mood (Hitsman et al., 2011). Because DSM-based indices are commonly used in treatment settings, their use in this research permits broader and more immediate application of the knowledge derived from them.

BackgroundLow-income smokers experience greater difficulty in quitting smoking than do other smokers. Providing financial incentives for treatment engagement increases smoking cessation success. This study models the cost-effectiveness of varying levels of financial incentives to maximise return on investment (ROI) for engaging low-income Medicaid recipients who smoke to take calls from a tobacco quit line.MethodsParticipants (N=1900) were recruited from May 2013 to June 2015 through quit line-based (n=980), clinic-based (n=444) or community-based referrals (n=476) into the Wisconsin Medicaid Quit Line Incentive project. Incentive (n=948) and control group participants (n=952) received $30 versus $0 per call, respectively, for taking up to five Wisconsin Tobacco Quit Line (WTQL) calls. Cost-effectiveness analyses estimated the incremental cost-effectiveness ratio for alternative financial incentives for engagement with WTQL calls. Probabilistic sensitivity analysis was employed to determine an optimal strategy for financial incentives to minimise the cost per individual who quit smoking.ResultsUsing fixed payments, the incremental cost-effectiveness ratio of $2316 per smoker who quit in the randomised trial decreased to $2150 per smoker who quit when the incentives were modelled at $20 per each of five WTQL calls taken. Using variable payments, the minimal cost per additional smoker who quit was $2125 when incentives for the first four WTQL calls were set at $20, and the financial payment for the fifth WTQL call was set at $70.ConclusionsModelling suggests that financial incentives in the amount of $20 per call for taking the first four quit line calls and $70 for taking a fifth quit line call maximise ROI to engage low-income smokers with evidence-based smoking cessation treatment.

To understand the dynamic process of cessation fatigue (i.e., the tiredness of trying to quit smoking) with respect to its average trend, effect on relapse, time-varying relations with craving and negative affect, and differences among genders and treatment groups.Randomized placebo-controlled clinical trial. Participants received either placebo, monotherapy (bupropion SR, nicotine patch, nicotine lozenge), or combined pharmacotherapy (bupropion SR+nicotine lozenge, nicotine patch+nicotine lozenge). Data were collected from 1504 daily smokers who were motivated to quit smoking. The participants completed baseline assessments and ecological momentary assessments for 2 weeks post-quit.Cessation fatigue reduced the likelihood of 6-month post-quit abstinence (OR=0.97, 95% CI (0.95, 0.99)), and was positively associated with craving and negative affect. After controlling for these two factors, average cessation fatigue increased over time. Compared to men, women experienced greater fatigue (t=-10.69, p0.0001) and a stronger relation between fatigue and craving (t=-8.80, p0.0001). The relationship between fatigue and negative affect was significantly stronger in men (t=5.73, p0.0001). Cessation fatigue was significantly reduced by combined pharmacotherapy (t=-13.4, p0.0001), as well as monotherapy (t=-6.2, p0.0001).Cessation fatigue was closely related to craving, negative affect, and cessation outcomes. Women reported greater cessation fatigue than men. Current treatments appeared to reduce fatigue and weaken its relations with craving and negative affect.

The multiphase optimization strategy (MOST) is a framework for not only evaluating but also optimizing behavioral interventions. A tool critical for MOST is the screening experiment, which enables efficient gathering of information for deciding which components to include in an optimized intervention. This article outlines a procedure for making decisions based on data from a factorial screening experiment. The decision making procedure is illustrated with artificial data generated to resemble empirical data. The illustration suggests that this approach is useful for selecting intervention components and settings based on the results of a factorial screening experiment. It is important to develop methods for making decisions based on factorial screening experiments. The approach demonstrated here is potentially useful, but has limited generalizability. Future research should develop additional decision making procedures for a variety of situations.

Introduction Self-regulation, a key component of the addiction process, has been challenging to model precisely in smoking cessation settings, largely due to the limitations of traditional methodological approaches in measuring behavior over time. However, increased availability of intensive longitudinal data (ILD) measured through ecological momentary assessment facilitates the novel use of an engineering modeling approach to better understand self-regulation. Methods Dynamical systems modeling is a mature engineering methodology that can represent smoking cessation as a self-regulation process. This article shows how a dynamical systems approach effectively captures the reciprocal relationship between day-to-day changes in craving and smoking. Models are estimated using ILD from a smoking cessation randomized clinical trial. Results A system of low-order differential equations is presented that models cessation as a self-regulatory process. It explains 87.32% and 89.16% of the variance observed in craving and smoking levels, respectively, for an active treatment group and 62.25% and 84.12% of the variance in a control group. The models quantify the initial increase and subsequent gradual decrease in craving occurring postquit as well as the dramatic quit-induced smoking reduction and postquit smoking resumption observed in both groups. Comparing the estimated parameters for the group models suggests that active treatment facilitates craving reduction and slows postquit smoking resumption. Conclusions This article illustrates that dynamical systems modeling can effectively leverage ILD in order to understand self-regulation within smoking cessation. Such models quantify group-level dynamic responses in smoking cessation and can inform the development of more effective interventions in the future.

Introduction The great majority of smokers relapse when they make quit attempts. Therefore, understanding the process of relapse may guide the development of more effective smoking cessation or relapse prevention treatments. The goal of this research is to extend our understanding of the context of initial lapses that occur within 8 weeks of quitting by using more comprehensive assessments of context, a contemporary sample, and sophisticated analytic techniques. Methods Participants from a randomized controlled smoking cessation trial completed baseline assessments of demographics and tobacco dependence, a daily smoking calendar to determine latency to lapse and relapse (7 consecutive days of smoking), and an assessment of initial lapse context (affect, location, activity, interpersonal, smoke exposure, and cigarette availability). Latent class analysis (LCA) was used to analyze the 6 early lapse (within the first 8 weeks; N = 551) context dimensions; logistic regression and Cox regression were used to relate context to cessation outcomes. Results LCA revealed 5 distinct initial lapse context classes (talking, with friends, angry; social; alone; with spouse, angry; and with smoking spouse) that were differentially related to cessation outcome. The easy availability of cigarettes characterized almost 75% of lapses, but being with friends, drinking, and not being at home were associated with a lower likelihood of progression to relapse. Conclusions Early lapsing is highly related to ultimate relapse, and lapsing in frequently experienced contexts seemed most strongly linked with progression to full relapse.

Background People with psychiatric disorders are more likely to smoke and smoke more heavily than the general population, and they suffer disproportionally from smoking-related illnesses. However, little is known about how quitting versus continuing to smoke affects mental health and the likelihood of developing a psychiatric diagnosis. This study used data from a large prospective clinical trial to examine the relations of smoking cessation success with psychiatric diagnoses 1 and 3 years after the target quit day. Methods This study enrolled 1504 smokers (83.9% white; 58.2% female) in a cessation trial that involved the completion of the Composite International Diagnostic Interview to assess psychiatric diagnoses and biochemical confirmation of point-prevalence abstinence at Baseline and Years 1 and 3. Results Regression analyses showed that, after controlling for pre-quit (past-year) diagnoses, participants who were smoking at the Year 3 follow-up were more likely to have developed and maintained a substance use or major depressive disorder by that time than were individuals who were abstinent at Year 3. Conclusions Quitting smoking does not appear to negatively influence mental health in the long-term and may be protective with respect to depression and substance use diagnoses; this should encourage smokers to make quit attempts and encourage clinicians to provide cessation treatment.

Background The development of tobacco use treatments that are effective for all smokers is critical to improving clinical and public health. The Multiphase Optimization Strategy (MOST) uses highly efficient factorial experiments to evaluate multiple intervention components for possible inclusion in an optimized tobacco use treatment. Factorial experiments permit analyses of the influence of patient characteristics on main and interaction effects of multiple, relatively discrete, intervention components. This study examined whether person-factor and smoking characteristics moderated the main or interactive effects of intervention components on 26-week self-reported abstinence rates. Methods This fractional factorial experiment evaluated six smoking cessation intervention components among primary care patients (N = 637): Prequit Nicotine Patch vs. None, Prequit Nicotine Gum vs. None, Preparation Counseling vs. None, Intensive Cessation In-Person Counseling vs. Minimal, Intensive Cessation Telephone Counseling vs. Minimal, and 16 vs. 8 Weeks of Combination Nicotine Replacement Therapy (NRT; nicotine patch + nicotine gum). Results Both psychiatric history and smoking heaviness moderated intervention component effects. In comparison with participants with no self-reported history of a psychiatric disorder, those with a positive history showed better response to 16- vs. 8-weeks of combination NRT, but a poorer response to counseling interventions. Also, in contrast to light smokers, heavier smokers showed a poorer response to counseling interventions. Conclusions Heavy smokers and those with psychiatric histories demonstrated a differential response to intervention components. This research illustrates the use of factorial designs to examine the interactions between person characteristics and relatively discrete intervention components. Future research is needed to replicate these findings.

Objective— To evaluate longitudinal changes in 6 inflammatory markers that predict cardiovascular disease events among smokers making a quit attempt and to characterize their cross-sectional associations between smoking and smoking heaviness. Approach and Results— In a longitudinal cohort study of contemporary smokers (n=1652), we evaluated (1) independent associations of smoking heaviness markers (exhaled carbon monoxide, cigarettes/d, pack-years) with inflammatory markers (C-reactive protein, D-dimer, fibrinogen, urinary F 2 isoprostane:creatinine [F 2 :Cr] ratio, white blood cell [WBC] count, myeloperoxidase) and (2) the effects of smoking cessation and continued smoking on these inflammatory markers after 1 year, among the 888 smokers who made an aided quit attempt as part of a randomized comparative effectiveness trial or standard care. There were strong, independent associations between smoking heaviness markers and the F 2 :Cr ratio, WBC, and myeloperoxidase (all P adj P P =0.02) than continuing smokers. Despite these increases, abstainers had significant decreases in F 2 :Cr ratio ( P P Conclusions— Smoking heaviness is associated with increased F 2 :Cr ratio, myeloperoxidase, and WBC counts. Cessation improves the F 2 :Cr ratio and WBC counts independent of weight change, suggesting reduced inflammation related to less oxidant stress.

Introduction Smokers' social networks vary in size, composition, and amount of exposure to smoking. The extent to which smokers' social networks change after a quit attempt is unknown, as is the relation between quitting success and later network changes. Methods Unique types of social networks for 691 smokers enrolled in a smoking-cessation trial were identified based on network size, new network members, members' smoking habits, within network smoking, smoking buddies, and romantic partners' smoking. Latent transition analysis was used to identify the network classes and to predict transitions in class membership across 3 years from biochemically assessed smoking abstinence. Results Five network classes were identified: Immersed (large network, extensive smoking exposure including smoking buddies), Low Smoking Exposure (large network, minimal smoking exposure), Smoking Partner (small network, smoking exposure primarily from partner), Isolated (small network, minimal smoking exposure), and Distant Smoking Exposure (small network, considerable nonpartner smoking exposure). Abstinence at years 1 and 2 was associated with shifts in participants' social networks to less contact with smokers and larger networks in years 2 and 3. Conclusions In the years following a smoking-cessation attempt, smokers' social networks changed, and abstinence status predicted these changes. Networks defined by high levels of exposure to smokers were especially associated with continued smoking. Abstinence, however, predicted transitions to larger social networks comprising less smoking exposure. These results support treatments that aim to reduce exposure to smoking cues and smokers, including partners who smoke. Implications Prior research has shown that social network features predict the likelihood of subsequent smoking cessation. The current research illustrates how successful quitting predicts social network change over 3 years following a quit attempt. Specifically, abstinence predicts transitions to networks that are larger and afford less exposure to smokers. This suggests that quitting smoking may expand a person's social milieu rather than narrow it. This effect, plus reduced exposure to smokers, may help sustain abstinence.

Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers’ increased and careful execution of such designs.

Item does not contain fulltext There has been relatively little attention focused on treatment strategies for smokers with panic attacks despite their increased risk of relapse. Panic and Smoking Reduction Treatment (PSRT) integrates standard smoking cessation treatment with an exposure-based intervention targeting the mechanisms underlying panic-smoking relations. Building upon emerging evidence supporting the efficacy of d-cycloserine (DCS) for augmenting exposure-based therapy, we are conducting an initial test of the efficacy of DCS for enhancing PSRT outcomes. Utilizing a randomized, double-blind trial comparing PSRT+DCS to PSRT+placebo, we will obtain initial effect sizes for short-term and long-term smoking cessation outcomes and perform an initial test of putative mechanisms. 6 p.