Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial.

Importance: Most people who smoke do not quit on their initial attempt. Objective: To determine the best subsequent strategy for nonabstinence following initial treatment with varenicline or combined nicotine replacement therapy (CNRT). Design, Setting, and Participants: Using a double-blind, placebo-controlled, sequential multiple assignment randomized trial, 490 volunteers were randomized to receive 6 weeks of varenicline or CNRT. After 6 weeks, nonabstainers were rerandomized to continue, switch, or increase medication dosage for 6 additional weeks. The study was conducted from June 2015 through October 2019 in a Texas tobacco treatment clinic. Interventions: The initial treatment was 2 mg/d of varenicline or the combined replacement therapy of a 21-mg patch plus 2-mg lozenge. The rerandomized participants either continued with their initial therapies, switched between varenicline and CNRT, or increased dosages either to 3-mg or more of varenicline or to a 42-mg patch and lozenges. All received weekly brief counseling. Main Outcomes and Measures: Biochemically verified 7-day point prevalence abstinence at the end of treatment at 12 weeks. Results: The 490 randomized participants (210 female [43%], 287 non-Hispanic White [58%], mean age, 48.1 years) smoked an average of 20 cigarettes per day. After the first phase, 54 participants in the CNRT group were abstinent and continued their therapy; of the 191 who were not abstinent, 151 were rerandomized, and the 40 who did not return for rerandomization were assigned to continue their initial CNRT condition in phase 2. The end-of-treatment abstinence rate for the 191 phase 1 nonabstainers was 8% (95% credible interval [CrI], 6% to 10%) for the 90 (47%) who continued at the dosage condition, 14% (CrI, 10% to 18%) for the 50 (33%) who increased their dosage, and 14% (95% CrI, 10% to 18%) for the 51 (34%) who switched to varenicline (absolute risk difference [RD], 6%; 95% CrI, 6% to 11%) with more than 99% posterior probability that either strategy conferred benefit over continuing the initial dosage. After the first phase, 88 participants in the varenicline group were abstinent and continued their therapy; of the 157 who were not abstinent, 122 were rerandomized and 35 who did not return for rerandomization were assigned to continue with the varenicline condition. The end-of-treatment abstinence rate for the 157 phase 1 nonabstainers was 20% (95% CrI, 16% to 26%) for the 39 (32%) who increased their varenicline dosage, 0 (95% CrI, 0 to 0) for the 41 (34%) who switched CNRT, and 3% (95% CrI, 1% to 4%) for the 77 (49%) who were assigned to the continued varenicline condition (absolute RD, -3%; 95% CrI, -4% to -1%) with more than 99% posterior probability that continuing varenicline at the initial dosage was worse than switching to a higher dosage. Furthermore, increasing the varenicline dosage had an absolute RD of 18% (95% CrI, 13% to 24%) and a more than 99% posterior probability of conferring benefit. The secondary outcome of continuous abstinence at 6 months indicated that only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages. Conclusions and Relevance: For individuals who smoked but did not achieve abstinence after treatment with varenicline, increasing the dosage enhanced abstinence vs continuing, whereas for nonabstainers initially treated with CNRT, a dosage increase or switch to varenicline enhanced abstinence and may be viable rescue strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02271919.

The role of marital satisfaction and social activities on parents' self-perception: evidence from Greek families of children with and without disabilities.

The purpose of this study is to explore the association between marital satisfaction and social activities with parents' self-perception. Self-perception included parents' sense of self and their attitudes and beliefs about who they are as individuals and as parents. Three hundred and twenty-seven parents, having either a child with (D1-target group) or without (D2-control group) a disability, were enrolled in the study. We hypothesized that self-perception of parents in the target group would be lower in all measures. We also hypothesized that low self-perception will correlate with parents' marital satisfaction and social activities. We found that parents of a child with disabilities reported significantly lower levels in all domains (self-perception, marital satisfaction and social activities) than parents of children without disabilities. Moreover, multigroup analyses confirmed that the structural paths between self-perception, marital satisfaction and social activities do not differ between D1 and D2 parents (χ2(127, N = 327) = 134.62, p>.05, CFI = 1.00 ≥ 0.90, RMSEA=.063 ≤ .080, SRMR = 0.054 < 0.08, TLI = 1.000 > 0.95). Results are discussed in terms of children's educational placement and their implications on children with and without disabilities unobstructed co-development and co-existence with their parents in the family context.

Deep sequencing of candidate genes identified 14 variants associated with smoking abstinence in an ethnically diverse sample.

Despite the large public health toll of smoking, genetic studies of smoking cessation have been limited with few discoveries of risk or protective loci. We investigated common and rare variant associations with success in quitting smoking using a cohort from 8 randomized controlled trials involving 2231 participants and a total of 10,020 common and 24,147 rare variants. We identified 14 novel markers including 6 mapping to genes previously related to psychiatric and substance use disorders, 4 of which were protective (CYP2B6 (rs1175607105), HTR3B (rs1413172952; rs1204720503), rs80210037 on chr15), and 2 of which were associated with reduced cessation (PARP15 (rs2173763), SCL18A2 (rs363222)). The others mapped to areas associated with cancer including FOXP1 (rs1288980) and ZEB1 (rs7349). Network analysis identified significant canonical pathways for the serotonin receptor signaling pathway, nicotine and bupropion metabolism, and several related to tumor suppression. Two novel markers (rs6749438; rs6718083) on chr2 are flanked by genes associated with regulation of bodyweight. The identification of novel loci in this study can provide new targets of pharmacotherapy and inform efforts to develop personalized treatments based on genetic profiles.

An introduction and practical guide to strategies for analyzing longitudinal data in clinical trials of smoking cessation treatment: Beyond dichotomous point-prevalence outcomes.

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3-12 months. This reinforces the concept of tobacco outcomes as a dichotomous state-one is, or is not, abstinent. Fortunately, there are several approaches available to handle longitudinal data that reflect the relapsing and remitting nature of tobacco use during treatment studies. In this paper, sponsored by the Society for Research on Nicotine and Tobacco's Treatment Research Network, we present an introductory overview of these techniques and their application in smoking cessation clinical trials. Topics discussed include models to examine abstinence outcomes (e.g., trajectory models of abstinence, models for transitions in smoking behavior, models for time to event), models that examine reductions in tobacco use, and models to examine joint outcomes (e.g., examining changes in use of more than one tobacco product). Finally, we discuss three additional relevant topics (i.e., heterogeneity of effects, handling missing data, power and sample size) and provide summary information about the type of model that can be used based on the type of data collected and the focus of the study. We encourage investigators to familiarize themselves with these techniques and use them in the analysis of data from clinical trials of smoking cessation treatment. IMPLICATIONS: Clinical trials of tobacco dependence treatment typically measure abstinence 3-12 months after participant enrollment. However, because smoking is a chronic relapsing condition, these measures of intervention success may not accurately reflect the common trajectories of tobacco abstinence and relapse. Several analytical techniques facilitate this type of outcome modeling. This paper is meant to be an introduction to these concepts and techniques to the global nicotine and tobacco research community including which techniques can be used for different research questions with visual summaries of which types of models can be used for different types of data and research questions.

Brief report: Characterization of electronic cigarette use among patients of a comprehensive cancer center.

BACKGROUND AND OBJECTIVES: We provide an initial characterization of e-cigarette use among adult cancer patients. METHODS: Data were collected between November 2020 and August 2022 at a comprehensive cancer center. RESULTS: Relatively few (4.59%) of the assessed patients (n = 47,117) reported ever using e-cigarettes. Over one-third of current e-cigarette users reported being current combustible cigarette users. DISCUSSION AND CONCLUSIONS: These data suggest that e-cigarette use is uncommon but associated with other tobacco use among adult cancer patients. SCIENTIFIC SIGNIFICANCE: This is among the first comprehensive surveys of adult cancer patient e-cigarette use that details the types of e-cigarette and other tobacco products used by this population.

Examining the Association between Abstinence from Smoking and Healthcare Costs Among Patients with Cancer.

Continuous tobacco use in cancer patients is linked to substantial healthcare costs due to increased risks and complications, whereas quitting smoking leads to improved treatment outcomes and cost reductions. Addressing the need for empirical evidence on the economic impact of smoking cessation, this study examined the association between smoking cessation and healthcare cost utilization among a sample of 930 cancer patients treated at The University of Texas MD Anderson Cancer Center's Tobacco Research and Treatment Program (TRTP). Applying conditional quantile regression and propensity scores to address confounding, our findings revealed that abstinence achieved through the TRTP significantly reduced the median cost during a 3-month period post-quitting by $1,095 (ß=-$1,095, p=0.007, 95%CI=[-$1,886, -$304]). Sensitivity analysis corroborated these conclusions, showing a pronounced cost reduction when outlier data were excluded. The long-term accrued cost savings from smoking cessation could potentially offset the cost of participation in the TRTP program, underscoring its cost-effectiveness. An important implication of this study is that by reducing smoking rates, healthcare systems can more efficiently allocate resources, enhance patient health outcomes, and lessen the overall cancer burden.

Comparable cigarette consumption data collected using timeline follow-back and digital diary among treatment-seeking smokers.

OBJECTIVE: The timeline follow-back interview is a common method of collecting daily cigarette consumption (cigarettes per day [CPD]) in smoking research. However, it may be subject to recall bias due to its reliance on retrospective reports. The increasing ownership of smartphones allows researchers to administer app-based digital diaries (DD) to collect CPD, which is expected to have less recall bias. Several studies have compared these two methods and found a noticeable discrepancy between them. However, these studies have mainly focused on the time window when smokers were smoking ad libitum. In this study, we wanted to determine the comparability of these two methods when treatment-seeking smokers are attempting to quit smoking. METHOD: In a cessation trial, treatment-seeking smokers (n = 251) reported their CPD using the timeline follow-back and DD methods over a 12-week treatment period. To evaluate the comparability, we used the Bland-Altman comparison approach for agreement, correlational analysis between CPD and biochemical measures, digit bias, and logistic regression for predicting abstinence. RESULTS: We found that the two methods exhibited good agreement, and the agreement did not vary as a function of consumption levels. Consistent with this agreement, CPD data from both methods showed similar correlations with biochemical measures of smoking and predicted 6-month abstinence in a comparable fashion. Despite the agreement, the DD method appeared to be more precise by having a lower digit bias than the timeline follow-back method. CONCLUSIONS: Capturing smoking behavior using either TLFB or DD approaches yields similar data while smokers are attempting to quit smoking. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Individual differences in late positive potential amplitude and theta power predict cue-induced eating.

Cue-induced reward-seeking behaviors are regulated by both the affective and cognitive control systems of the brain. This study aimed at investigating how individual differences in affective and cognitive responses to cues predicting food rewards contribute to the regulation of cue-induced eating. We recorded electroencephalogram (EEG) from 59 adults while they viewed emotional and food-related images that preceded the delivery of food rewards (candies) or non-food objects (beads). We measured the amplitude of the late positive potential (LPP) in response to a variety of motivationally relevant images and power in the theta (4-8 Hz) frequency band after candies or beads were dispensed to the participants. We found that individuals with larger LPP responses to food images than to pleasant images (C>P group) ate significantly more during the experiment than those with the opposite response pattern (P>C group, p < 0.001). Furthermore, we found that individuals with higher theta power after dispensation of the candy than of the bead (θCA>θBE) ate significantly more than those with the opposite response pattern (θBE>θCA, p < 0.001). Finally, we found that the crossed P>C and θBE>θCA group ate less (p < 0.001) than did the other three groups formed by crossing the LPP and theta group assignments, who exhibited similar eating behavior on average (p = 0.662). These findings demonstrate that individual differences in both affective and cognitive responses to reward-related cues underlie vulnerability to cue-induced behaviors, underscoring the need for individualized treatments to mitigate maladaptive behaviors.

The Effects of Scheduled Smoking Reduction and Precessation Nicotine Replacement Therapy on Smoking Cessation: Randomized Controlled Trial With Compliance.

BACKGROUND: Smoking remains a major public health problem, and it is important to provide a variety of efficacious and appealing options to encourage smokers to quit smoking. Scheduled smoking is a method of gradual reduction, preparing smokers to quit by systematically reducing cigarette consumption according to a predetermined schedule that increases the time between cigarette consumption. Gradual reduction may be preferred to abrupt quitting, but the efficacy of this cessation approach is unclear. OBJECTIVE: This study aims, first, to evaluate the overall effectiveness of scheduled smoking alone, or in combination with precessation nicotine replacement therapy (NRT), versus standard NRT starting on the quit date with no prior smoking reduction and, second, to evaluate the impact of schedule compliance on the effectiveness of the intervention. METHODS: A total of 916 participants recruited from the Houston metropolitan area were randomly assigned to 1 of the following 3 groups: scheduled smoking plus a precessation nicotine patch (n=306, 33.4%), scheduled smoking only with no precessation patch (n=309, 33.7%), and enhanced usual care (n=301, 32.9%) control. The primary abstinence outcomes were carbon monoxide-verified, self-reported, 7-day point prevalence abstinence at 2 and 4 weeks after the quit date. Unadjusted and adjusted logistic regression analyses were performed to evaluate the intervention effect. Scheduled smoking was implemented using a handheld device for 3 weeks before quitting. This trial was not registered because data collection began before July 1, 2005. RESULTS: Results for the first aim showed no overall differences in abstinence among the 3 groups in both the unadjusted and adjusted models. However, the results for the second aim showed a clear effect on abstinence by schedule compliance at 2 and 4 weeks and 6 months after quitting (odds ratio [OR] 2.01, 95% CI 1.31-3.07), 4 weeks (OR 1.58, 95% CI 1.05-2.38), and 6 months (OR 1.68, 95% CI 1.04-2.64), with the differences at 2 and 4 weeks after quitting being the most robust. We also found that scheduled smoking was related to a reduction in nicotine withdrawal, negative affect, and craving when compared with the controls. CONCLUSIONS: Scheduled smoking, when combined with precessation use of NRT, can result in significantly higher abstinence rates than usual care (abrupt quitting with NRT), particularly in the early postquit phase (2 and 4 weeks after cessation) when smokers are compliant with the procedure. Scheduled smoking also produced a better overall quitting experience by reducing symptoms of nicotine withdrawal and craving, in comparison with usual care, which could encourage future quit attempts. Studies in this area should focus on the use of counseling or other methods to improve adherence.

Polysubstance use and its correlation with psychosocial and health risk behaviours among more than 95,000 Norwegian adolescents during the COVID-19 pandemic (January to May 2021): a latent profile analysis.

Background: Polysubstance use represents an adolescent health risk; however, large-scale studies investigating this issue during the COVID-19 pandemic are scarce. We aim to (i) characterise substance use profiles among adolescents and (ii) identify correlates of such substance use profiles. Methods: Norwegian nationwide survey data from 2021 were analysed using latent profile analysis. Participants were 97,429 adolescents aged 13-18. We assessed cigarette, e-cigarette and snus use, alcohol consumption, and cannabis and other illicit drug use. Correlates included psychosocial variables, health risk behaviours, and COVID-19-related problems. Findings: We identified three adolescent profiles; those who use no substances (n = 88,890; 91%); those who use snus and alcohol (n = 6546; 7%); and those who use multiple substances (i.e., polysubstance profile; n = 1993; 2%). Boys, older adolescents, adolescents with lower socio-economic status, and those reporting low levels of parental control, and higher parental alcohol use, mental health problems, pain-related variables, and other health risk behaviours were most likely to be in the polysubstance profile. Adolescents with social and mental health issues related to COVID-19 were more at risk of being in the polysubstance profile. Adolescents who use snus and alcohol showed similar patterns of risk factors, but on a somewhat lower level than those in the polysubstance profile. Interpretation: Adolescents who use multiple substances have an unhealthier lifestyle, are at a higher risk of experiencing psychosocial impairments, and report more problems related to the COVID-19 pandemic. Preventative strategies to reduce polysubstance use might help promote psychosocial well-being in adolescents across various life domains. Funding: This study was funded by two grants from the Research Council of Norway (project #: 288083 and 300816). The Norwegian Directorate of Health has funded the data collection. The Research Council of Norway and the Norwegian Directorate of Health have not had any role in study design, data collection, data analysis, interpretation, and writing of the report.

Neuroaffective reactivity profiles are associated with vulnerability to e-cigarette use.

BACKGROUND: We tested whether neuroaffective responses to motivationally salient stimuli are associated with vulnerability to cue-induced e-cigarette use in e-cigarette naïve adults who smoke daily. We hypothesized that individuals with stronger neuroaffective responses to nicotine-related cues than to pleasant stimuli (the C>P reactivity profile) would be more vulnerable to cue-induced nicotine self-administration than individuals with stronger neuroaffective responses to pleasant stimuli than to nicotine-related cues (the P>C reactivity profile). METHODS: We used event-related potentials (ERPs, a direct measure of cortical activity) to measure neuroaffective reactivity to pleasant, unpleasant, neutral, and nicotine-related cues indicating the opportunity to use an e-cigarette in 36 participants. For each picture category, we computed the amplitude of the late positive potential (LPP), a robust index of motivational salience. To identify each individual's neuroaffective reactivity profile we applied k-means cluster analysis on the LPP responses. We compared the e-cigarette use frequency across profiles using quantile regression for counts. RESULTS: K-means cluster analysis assigned 18 participants to the C>P profile and 18 participants to the P>C profile. Individuals with the C>P neuroaffective profile used the e-cigarette significantly more often than those with the P>C profile. Significant differences in the number of puffs persisted across different quantiles. CONCLUSIONS: These results support the hypothesis that individual differences in the tendency to attribute motivational salience to drug-related cues underlie vulnerability to cue-induced drug self-administration. Targeting the neuroaffective profiles that we identified with tailored treatments could improve clinical outcomes.

A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening.

BACKGROUND: Patients eligible for lung cancer screening (LCS) are those at high risk of lung cancer due to their smoking histories and age. While screening for LCS is effective in lowering lung cancer mortality, primary care providers are challenged to meet beneficiary eligibility for LCS from the Centers for Medicare & Medicaid Services, including a patient counseling and shared decision-making (SDM) visit with the use of patient decision aid(s) prior to screening. METHODS: We will use an effectiveness-implementation type I hybrid design to: 1) identify effective, scalable smoking cessation counseling and SDM interventions that are consistent with recommendations, can be delivered on the same platform, and are implemented in real-world clinical settings; 2) examine barriers and facilitators of implementing the two approaches to delivering smoking cessation and SDM for LCS; and 3) determine the economic implications of implementation by assessing the healthcare resources required to increase smoking cessation for the two approaches by delivering smoking cessation within the context of LCS. Providers from different healthcare organizations will be randomized to usual care (providers delivering smoking cessation and SDM on site) vs. centralized care (smoking cessation and SDM delivered remotely by trained counselors). The primary trial outcomes will include smoking abstinence at 12-weeks and knowledge about LCS measured at 1-week after baseline. CONCLUSION: This study will provide important new evidence about the effectiveness and feasibility of a novel care delivery model for addressing the leading cause of lung cancer deaths and supporting high-quality decisions about LCS. GOV PROTOCOL REGISTRATION: NCT04200534 TRIAL REGISTRATION: ClinicalTrials.govNCT04200534.

The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial.

IMPORTANCE: Improving treatment outcomes for smokers with major depressive disorder (MDD) can have significant public health implications. OBJECTIVE: To evaluate the safety and efficacy of smoking cessation pharmacotherapy among smokers with MDD. DESIGN: Secondary analysis of a randomized, double-blind, active- (nicotine patch) and placebo-controlled trial of 12 weeks of either varenicline or bupropion with a 12-week follow-up. PARTICIPANTS: Community volunteers 18-75 years of age; smoke 10+ cigarettes/day; with clinically stable MDD (N = 2635) or no psychiatric disorder (N = 4028), from 140 sites in 16 countries. INTERVENTION: Twelve weeks of pharmacotherapy (placebo [PLA], nicotine replacement therapy [NRT], bupropion [BUP], varenicline [VAR]) plus brief cessation counseling. MEASURE(S): Primary safety outcome: the occurrence of ≥1 treatment-emergent, moderate to severe neuropsychiatric adverse event (NPSAE). Primary efficacy outcome: biochemically confirmed continuous abstinence (CA) during the final 4 weeks of treatment (Weeks 9-12). RESULTS: A total of 6653 participants (56% female; 39% MDD) ~47 years old. Risk of NPSAEs did not differ by medication for MDD. MDD had higher risk (p < .0001) for NPSAEs than the NPC. Efficacy (6653; intent-to-treat): CA rates for MDD versus NPC respectively were 31.2% versus 38.0% VAR; 23.0% versus 26.1% BUP; 22.6% versus 26.4% NRT; and 13.4% versus 13.7% PLA but no differential treatment effect was noted within the cohorts. All active treatments differed from PLA but VAR showed the largest effect. CONCLUSIONS: Results suggest that for MDD smokers, inclusive of those with recurrent episode, varenicline plus counseling may be the best pharmacological option for the treatment of smoking given its greater efficacy effect size and similar risk of NPSAEs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01456936. https://clinicaltrials.gov/ct2/show/NCT01456936.

Bupropion XL and SR have similar effectiveness and adverse event profiles when used to treat smoking among patients at a comprehensive cancer center.

BACKGROUND AND OBJECTIVES: Bupropion extended-release (XL; once-daily dosing) has equal efficacy with the sustained-release (SR) formulation (twice-daily dosing) for treating depression, but no studies have compared the two formulations for the treatment of smoking. In a naturalistic open-label study, we compared the effectiveness and the adverse event profiles of XL and SR in treating cancer patients for smoking. METHODS: Cancer patients (N = 648) were prescribed bupropion XL (n = 454) or SR (n = 194) alone or in combination with nicotine replacement therapy (NRT) for treating smoking from September 2006 to December 2017. We analyzed 7-day point prevalence abstinence at end-of-treatment (EOT; 3 months postmedication initiation) and evaluated for noninferiority. We also analyzed the adverse event profile differences between the medications. RESULTS: There were no significant differences in abstinent rates at EOT between bupropion XL and SR when using intent-to-treat models, regardless of concomitant NRT. XL demonstrated noninferiority in treatment efficacy compared to SR when excluding those on combined treatment with NRT. Further, there were no significant differences in spontaneously reported adverse events between XL and SR. CONCLUSIONS: Our data did not reveal a difference between bupropion XL and SR formulations in terms of effectiveness or adverse event profiles among cancer patients prescribed bupropion alone or in combination with NRTs to quit smoking. SCIENTIFIC SIGNIFICANCE: In this first published direct comparison of their effectiveness and adverse event profiles, we found that bupropion XL is likely therapeutically equivalent to bupropion SR when treating smoking among cancer patients, and produces similar side effects.

The Impact of Treatment for Smoking on Breast Cancer Patients' Survival.

BACKGROUND: Smoking negatively affects overall survival after successful breast cancer (BC) treatment. We hypothesized that smoking cessation would improve survival outcomes of BC patients who were smokers at the time of diagnosis. METHODS: This was a retrospective analysis of self-identified smokers with BC treated at The University of Texas MD Anderson Cancer Center. Patient demographics, date of diagnosis, tumor stage, tobacco treatment program (TP) participation, and time to death were extracted from our departmental databases and institutional electronic health records. We examined associations between tobacco abstinence status and survival using survival models, with and without interactions, adjusted for personal characteristics and biomarkers of disease. RESULTS: Among all 31,069 BC patients treated at MD Anderson between 2006 and 2017, we identified 2126 smokers (6.8%). From those 2126 self-identified smokers, 665 participated in the TP, reporting a conservative estimate of 31% abstinence (intent-to-treat) 9 months into the program. Patients without reported follow-up abstinence status (including TP and non-TP participants) were handled in the analyses as smokers. Survival analysis controlled for multiple factors, including disease characteristics and participation in the TP, indicated that abstainers were more likely to be alive with no evidence of disease compared to non-abstainers (HR, 0.593; 95% CI, 0.386-0.911; p = 0.017). CONCLUSION: Our results suggest that quitting smoking is associated with improved survival among BC patients who were smokers at time of diagnosis across all tumor stages. Comprehensive approaches for smoking cessation in patients diagnosed with BC may prolong survival when started as early as the time of diagnosis.

Topiramate decreases the salience of motivationally relevant visual cues among smokers with alcohol use disorder.

BACKGROUND: There is preliminary evidence that the anticonvulsant topiramate increases the likelihood of both smoking and alcohol abstinence among smokers with alcohol use disorder (AUD), but its therapeutic mechanism has not been determined. We used event-related potentials (ERPs) to evaluate topiramate's effect on the salience of drug-related, emotional, and neutral pictorial cues to identify whether one of its potential therapeutic mechanisms involves reduction of the salience of motivationally relevant cues. METHODS: Participants enrolled in a multisite clinical trial treating smokers with AUD were randomly assigned to receive placebo, low-dose topiramate (up to 125 mg/day), or high-dose topiramate (up to 250 mg/day), along with brief behavioral compliance enhancement treatment. A subsample (n = 101) completed ERP assessments at baseline (1 week pre-medication) and week 5 (5 weeks on medication; 1 week pre-quit). We assessed the salience of pleasant, unpleasant, cigarette-related, alcohol-related, and neutral pictorial cues using the late positive potential (LPP) ERP component and measured self-reported substance use, reinforcement, craving, and withdrawal. RESULTS: Five weeks of high-dose topiramate treatment decreased LPP amplitudes in response to both emotional (pleasant and unpleasant) and drug-related cues (alcohol and cigarette), but not to neutral cues. However, results showed that the LPPs were not significant mediators of the relationship between topiramate dose and post-quit measures of substance use, reinforcement, craving, or withdrawal. CONCLUSIONS: These findings suggest that high-dose topiramate (up to 250 mg/day) decreases the motivational salience of both drug-related and emotional cues among smokers with AUD. However, the nonsignificant mediation analyses preclude any firm conclusions about whether this effect represents one of topiramate's therapeutic mechanisms of action.

Satiety does not affect neuroaffective electrophysiological responses to food-related or emotional visual cues.

Continuing to eat even when full leads to excessive calorie consumption and obesity. Thus, understanding brain responses to food cues when satiated has important implications for weight control interventions. We used the late positive potential (LPP, a component of the event-related potentials (ERP) indexing motivational relevance) to determine the extent to which satiety affects brain responses to images of highly palatable foods (high-fat, high-sugar), high and low motivationally relevant (pleasant, unpleasant) and neutral stimuli in a sample of obese (body mass index [BMI] ≥ 30 kg/m2) and lean (BMI < 25 kg/m2) individuals. Satiated individuals (N = 55, 21 with BMI ≥ 30 kg/m2) were fed a nutritional drink prior to the experimental session and were individually matched with 55 unsatiated individuals who saw the same images during a passive viewing task. Satiety did not affect LPP response to food-related or motivationally relevant cues in either BMI < 25 kg/m2 or BMI ≥ 30 kg/m2 individuals (p = .6). Irrespective of satiety, all participants showed larger LPPs as a function of the images' motivational relevance. There were no differences in LPP amplitude between BMI < 25 kg/m2 and BMI ≥ 30 kg/m2 individuals for any picture category, including food. However, within-group comparisons showed that BMI < 25 kg/m2 individuals had larger LPPs to low motivationally relevant pleasant images than to food-related cues (p < .001); this difference was not significant for BMI ≥ 30 kg/m2 individuals. Although satiety does not affect LPP responses to food-related cues, these results highlight the importance of evaluating reactivity to food-related cues in relation to other motivationally relevant stimuli. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Modeling neuroaffective biomarkers of drug addiction: A Bayesian nonparametric approach using dirichlet process mixtures.

BACKGROUND: The properties of neurophysiological processes related to addiction have received much attention in the literature. However, empirical evidence of meaningful and useful characterization of these processes is limited. Recent studies have found that electrophysiological responses to emotional and drug-related cues can be used to create profiles that reliably predict smoking relapse. NEW METHOD: This paper evaluates the validity of classifying electrophysiological responses into distinct profiles using a Bayesian dirichlet process mixture (DPM) model. The DPM is a Bayesian nonparametric (BNP) method to modeling unknown number of profiles characterized by uncertainty in cluster membership and in cluster number. RESULTS: The DPM model confirmed previously identified neuroaffective reactivity profiles, but also revealed a finer level of granularity in the clustering. Specifically, in addition to the two clusters previously identified in the literature, the BNP methods identified a cluster of individuals showing similar responses to smoking, pleasant, neutral and unpleasant cues. COMPARISON WITH EXISTING METHODS: BNP models provide an alternative to the k-mean clustering approach to modeling EEG-based neuroaffective profiles. Unlike k-means clustering, BNP models compute the probability that a subject belongs to a cluster while taking into consideration uncertainty in the number of clusters. CONCLUSIONS: Our results confirm the reliability of the two clusters previously identified in these data, but also provide new insights by revealing a cluster that presented similar responses to stimuli with different contents. This finding may be related to the uncertainty in classification or overlapping brain-reactivity profiles.

Estimating statistical power for event-related potential studies using the late positive potential.

The late positive potential (LPP) is a common measurement used to study emotional processes of subjects in ERP paradigms. Despite its extensive use in affective neuroscience, there is presently no gold standard for how to appropriately power ERP studies using the LPP. The present study investigates how the number of trials, number of subjects, and magnitude of the effect size affect statistical power in analyses of the LPP. Using Monte Carlo simulations of ERP experiments with varying numbers of trials, subjects, and synthetic effects of known magnitude, we measured the probability of obtaining a statistically significant effect in 1,489 experiments repeated 1,000 times each. Predictably, our results showed that statistical power increases with increasing numbers of trials and subjects and at larger effect sizes. We also found that higher levels of statistical power can be achieved with lower numbers of subjects and trials and at lower effect sizes in within-subject than in between-subjects designs. Furthermore, we found that, as subjects are added to an experiment, the slope of the relationship between effect size and statistical power increased and shifted to the left until the power asymptoted to nearly 100% at higher effect sizes. This suggests that adding more subjects greatly increases statistical power at lower effect sizes (<1 µV) compared with more robust (>1.5 µV) effect sizes. We confirmed the results from the simulations based on the synthetic effects by running a new series of simulated experiments based on real data collected while participants looked at emotional images.