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Aims: To identify subpopulations of dual users of combustible and electronic cigarettes using current smoking and vaping behaviors. Design: Secondary analysis of baseline data from a randomized controlled trial testing a smoking cessation intervention for dual users. Finite mixture modeling of frequency, quantity, and dependence on combustible and electronic cigarettes was used to identify classes. Demographics and additional smoking and vaping variables were used to further characterize the classes. Setting: United States. Participants: A total of 2896 adults who smoked weekly for the past year and vaped weekly for the past month. Measurements Self‐report baseline measures assessed demographics and smoking and vaping behaviors and characteristics including days of use per week, frequency of use within a day, time to first use after waking, urges to smoke, smoking cessation motivation, self‐efficacy to abstain from smoking, months since vaping initiation, reasons for initiating and maintaining vaping, and future plans to stop vaping. Findings Eight probabilistic classes were identified and well‐defined (relative entropy = 0.95, Lo–Mendell–Rubin adjusted likelihood ratio test P < 0.0001; class probabilities 0.89–0.97). In general, classes crossed two levels of smoking with four levels of vaping. The largest class (31%) had relatively high levels of smoking (72% daily, 56% 11+ cigarettes per day [CPD], 96% within 30 minutes of waking) and vaping (74% daily, 100% 20+ electronic‐CPD, 74% <30 minutes). The next largest class (27%) had relatively high levels of vaping (93% daily, 100% 20+ electronic‐CPD, 82% <30 minutes) and very low levels of smoking (28% daily, 12% 11+ CPD, 0% <30 minutes). The six smaller classes (3%–13%) also had distinct smoking and vaping behaviors. All eight classes exhibited distinguishing characteristics beyond current smoking and vaping behaviors. Conclusions: Dual users of combustible and electronic cigarettes are not a homogeneous population, having eight well‐defined prospective subpopulations. [ABSTRACT FROM AUTHOR]

Background: Cue exposure for extinguishing conditioned urges to smoking cues has been promising in the laboratory, but difficult to implement in natural environments. The recent availability of augmented reality (AR) via smartphone provides an opportunity to overcome this limitation. Testing the ability of AR to elicit cue-provoked urges to smoke (ie, cue reactivity [CR]) is the first step to systemically testing the efficacy of AR for cue exposure therapy.Objectives: To test CR to smoking-related AR cues compared to neutral AR cues, and compared to in vivo cues.Methods: A 2 × 2 within-subject design comparing cue content (smoking vs. neutral) and presentation modality (AR vs. in vivo) on urge response. Seventeen smokers viewed six smoking-related and six neutral cues via AR smartphone app and also six smoking and six neutral in vivo cues. Participants rated their urge to smoke and reality/co-existence of the cue.Results: Average urge to smoke was higher following smoking-related AR images (Median = 7.50) than neutral images (Median = 3.33) (Z = -3.44; p = .001; d = 1.37). Similarly, average urge ratings for in vivo smoking-related cues (Median = 8.12) were higher than for neutral cues (Median = 2.12) (Z = -3.44; p = .001; d = 1.64). Also, greater CR was observed for in vivo cues than for AR cues (Z = -2.67, p = .008; d = .36). AR cues were generally perceived as being realistic and well-integrated.Conclusions: CR was demonstrated with very large effect sizes in response to AR smoking cues, although slightly smaller than with in vivo smoking cues. This satisfies the first criterion for the potential use of AR for exposure therapy.Implications: This study introduces AR as a novel modality for presenting smoking-related stimuli to provoke cue reactivity, and ultimately to conduct extinction-based therapy. AR cues presented via a smartphone have the advantage over other modes of cue presentation (pictures, virtual reality, in vivo, etc.) of being easily transportable, affordable, and realistic, and they can be inserted in a smokers' natural environment rather than being limited to laboratory and clinic settings. These AR features may overcome the generalizability barriers of other methods, thus increasing clinical utility for cue exposure therapies. [ABSTRACT FROM AUTHOR]

Objective: Smoking cessation improves quality of life (QOL) in the general population. However, there is limited information on the role of smoking status on QOL among cancer patients. Moreover, previous studies tended to analyze smoking status dichotomously and at a single point in time, potentially reducing the strength of the relation between smoking cessation and QOL. This study examined the association of smoking abstinence and QOL over time, including depression, pain, and fatigue in patients with a wide variety of cancers.Methods: Participants were 332 cancer patients (eg, gynecologic, breast, thoracic, head and neck, and genitourinary) who had been abstinent for at least 24 hours. Days abstinent and QOL were assessed at baseline and 2, 6, and 12 months later. Latent growth curve models examined if days abstinent was associated with QOL at each assessment. Baseline demographics (eg, sex and income) and smoking history variables (eg, nicotine dependence) were used as time-invariant covariates.Results: The final model for each QOL component had good-to-excellent fit. More days abstinent was associated with lower depression at all follow-ups and with lower fatigue at 12 months but was not associated with pain.Conclusions: QOL was better among patients who quit smoking for longer periods. Findings suggest different timelines, with smoking abstinence most immediately associated with lower depression, followed by lower fatigue. Although pain decreased over time, it was not associated with length of smoking abstinence. Results reinforce the relationship between sustained smoking cessation and QOL, which should be communicated to patients. [ABSTRACT FROM AUTHOR]

Background and Aims: Most e‐cigarette users who also smoke combustible cigarettes (dual users) begin vaping to quit smoking, yet only a subset succeeds. We hypothesized that reinforcing characteristics of e‐cigarettes (vaping reinforcement) would positively predict smoking cessation propensity (SCP) among dual users. Design Secondary analysis of cross‐sectional baseline data from dual users in an ongoing smoking cessation trial. Exploratory and confirmatory factor analysis (EFA and CFA) created latent variables for vaping reinforcement and SCP. A structural equation modeling (SEM) approach was used to test the hypothesis. Setting: United States. Participants: A national sample of dual users of combustible and electronic cigarettes who smoke and vape at least once per week (n = 2896) were enrolled (63% male; mean age = 29.9 years) into a randomized controlled trial in which they would receive either smoking cessation materials or no smoking cessation materials. Measurements Vaping reinforcement was indexed by vaping frequency (days/week vaping, times/day vaping, puffs/e‐cigarette use), e‐cigarette characteristics [numbers of modifications and tobacco or non‐tobacco flavors, nicotine content (mg) and positive e‐cigarette expectancies]. SCP was measured by items of confidence, commitment to being smoke‐free, cessation motivation (contemplation ladder), change in cigarettes per day since beginning e‐cigarette use and negative smoking expectancies. Findings Four factors emerged from the EFA: vaping propensity (vaping frequency, positive expectancies), vaping enthusiasm (e‐cigarette modifications, using non‐tobacco flavors, puffs per use), nicotine/tobacco flavor (nicotine strength, tobacco flavors) and SCP (negative expectancies about smoking, motivation to quit smoking, reduction in smoking). A CFA upheld the exploratory factor structure [root mean square error of approximation (RMSEA) = 0.046, CFI = 0.91]. An SEM with the three vaping latent variables directly predicting SCP had good model fit (RMSEA = 0.030, CFI = 0.97) with a positive relationship of vaping propensity (0.509, P < 0.001), and small negative relationships of vaping enthusiasm (−0.158, P = 0.014) and nicotine/tobacco flavor (−0.230, P < 0.001). Conclusions: Among e‐cigarette users who also smoke combustible cigarettes, frequent vaping combined with positive e‐cigarette expectancies appears to predict greater smoking cessation propensity. However, vaping enthusiasm (measured by e‐cigarette modifications, using non‐tobacco flavors and puffs per use), higher nicotine content and use of tobacco flavored solution may reduce cessation propensity. [ABSTRACT FROM AUTHOR]

Objective: Smoking tobacco cigarettes after a cancer diagnosis increases risk for several serious adverse outcomes. Thus, patients can significantly benefit from quitting smoking. Electronic cigarettes are an increasingly popular cessation method. Providers routinely ask about combustible cigarette use, yet little is known about use and communication surrounding e-cigarettes among patients with cancer. This study aims to describe patterns, beliefs, and communication with oncology providers about e-cigarette use of patients with cancer.Methods: Patients with cancer (N = 121) who currently used e-cigarettes were surveyed in a cross-sectional study about their patterns and reasons for use, beliefs, and perceptions of risk for e-cigarettes, combustible cigarettes, and nicotine replacement therapies. Patient perspectives on provider communication regarding e-cigarettes were also assessed.Results: Most participants identified smoking cessation as the reason for initiating (81%) and continuing (60%) e-cigarette use. However, 51% of patients reported current dual use of combustible cigarettes and e-cigarettes, and most patients reported never having discussed their use of e-cigarettes with their oncology provider (72%). Patients characterized e-cigarettes as less addictive, less expensive, less stigmatizing, and less likely to impact cancer treatment than combustible cigarettes (Ps < .05), and more satisfying, more useful for quitting smoking, and more effective at reducing cancer-related stress than nicotine replacement therapies (Ps < .05).Conclusions: Patients with cancer who use e-cigarettes have positive attitudes toward these devices and use them to aid in smoking cessation. This study also highlights the need for improved patient-provider communication on the safety and efficacy of e-cigarettes for smoking cessation. [ABSTRACT FROM AUTHOR]

Prior research indicates bisexual individuals have higher smoking and vaping rates and heightened vulnerability to negative health outcomes. Thus, we compared adult bisexual (n = 294) and heterosexual (n = 2412) participants enrolled in a smoking cessation trial on baseline smoking and vaping use behaviors, motivations, and expectancies/beliefs as well as follow-up smoking and vaping status. This is a secondary analysis of a large randomized controlled trial testing a smoking cessation intervention for dual users of combustible and electronic cigarettes (e-cigarettes) in the United States. Self-reported 7-day point prevalence smoking and vaping abstinence were collected at 3-, 12-, and 24-month assessments. Bisexual and heterosexual participants did not differ in sociodemographic variables or baseline smoking and vaping history and behavior. We found significant differences among bisexual and heterosexual individuals in smoking and vaping beliefs/expectancies. Specifically, bisexual participants expressed overall greater positive expectancies regarding smoking and vaping, such as smoking and vaping to reduce negative affect and stress. There were no differences in smoking at any follow-up assessment. Only at 3 months were bisexual individuals more likely to be abstinent from vaping and less likely to be dual users than heterosexual individuals. Despite similar smoking and vaping status over time, bisexual individuals reported greater positive expectancies regarding smoking and vaping. Our findings revealed few targets for tailoring cessation interventions to bisexual individuals; thus, it is possible that there may be greater utility in targeting the disparities in prevalence (i.e., via prevention efforts). [ABSTRACT FROM AUTHOR]

Objectives: Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions. Method: Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment. Results: Recruitment is ongoing. Conclusions: The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes. Trial registration: The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1. [ABSTRACT FROM AUTHOR]

Introduction: Hispanic/Latinx smokers in the United States are often treated as a homogeneous group. However, population-based studies suggest that cigarette use differs among Hispanic/Latinx subgroups by sociodemographic or sociocultural characteristics. This secondary analysis aimed to advance the limited literature by examining differences in smoking-related variables.Aims and Methods: We used baseline data from a randomized controlled trial testing a self-help Spanish-language smoking cessation intervention. Puerto Rican (PR), Mexican, and Cuban, the three largest Hispanic/Latinx subgroups in the sample (N = 1028), were first compared on sociodemographic and sociocultural variables (acculturation and familism). Primary analyses assessed subgroup differences in cigarette use variables (eg, cigarettes per day [CPD], nicotine dependence [Fagerström Test for Nicotine Dependence], and daily smoking) and smoking-related cognitive constructs (motivation to quit, smoking outcome expectancies, and abstinence self-efficacy) controlling for sociodemographic and sociocultural variables. Additional analyses explored differences between men and women within subgroups.Results: Mexicans exhibited the lowest levels of daily smoking (90% vs. 95% Cubans and 96% PR; p = .001), CPD (M = 13.5, SD = 9.5 vs. M = 20.1, SD = 9.9 Cubans and M = 16.7, SD = 10.1 PR; p = .016), and nicotine dependence (M = 4.2, SD = 2.3 vs. M = 6.0, SD = 2.1 Cubans and M = 5.7, SD = 2.2 PR; p < .001), with no differences between PRs and Cubans. Within-subgroup comparisons between men and women showed the most differences among PRs (eg, men were more nicotine dependent [M = 6.0, SD = 1.9] than women [M = 5.4, SD = 2.3; p = .041]) and Cubans (eg, men smoked more CPD [M = 22.2, SD = 12.2] than women [M = 19.3, SD = 12.0; p = .042]), and the fewest among Mexicans.Conclusions: Findings support heterogeneity within Hispanic/Latinx smokers and highlight the potential utility of examining sociodemographic, sociocultural, and smoking characteristics important for developing salient cessation interventions.Implications: Findings demonstrate that treatment-seeking Hispanic/Latinx smokers in the United States differ in sociodemographic, sociocultural, and smoking-related variables (cigarette use and smoking-related cognitive constructs) by subgroup (ie, PR, Mexican, and Cuban) and within subgroups by sex. These differences suggest that heterogeneity among subgroups should be considered when developing cessation interventions for Hispanics/Latinxs. Future research should examine how differences in sociodemographic and smoking-related variables impact intervention outcomes and explore the role of sociocultural factors (eg, acculturation and familism) as determinants of cessation. [ABSTRACT FROM AUTHOR]

Background: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish‐language, extended self‐help smoking cessation intervention among Hispanic smokers. Methods: A 2‐arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish‐language self‐help booklet from the National Cancer Institute. The primary outcome was self‐reported 7‐day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost‐effectiveness was also evaluated. All statistical tests were 2‐sided. Results: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P <.001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18‐2.02; P =.002). Men exhibited a strong intervention effect at all assessments (P values <.001), whereas the intervention effect for women was observed only at 6 and 12 months (P values <.018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months. Conclusions: A culturally relevant, Spanish‐language intervention was efficacious and cost‐effective for smoking cessation. Lay Summary: Research is needed to develop interventions for ethnic minority smokers.The aim of the current study was to test a Spanish‐language adaptation of a validated and easily implemented self‐help smoking cessation intervention in a nationwide randomized controlled trial.The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self‐help booklet.Participants also were more satisfied with the intervention, and it was cost‐effective.Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking. This large, nationwide randomized controlled trial demonstrates that a culturally relevant, Spanish‐language, extended self‐help intervention is efficacious and cost‐effective for smoking cessation, and it supports the tailoring of interventions to Hispanics by identifying and integrating cultural values. The evaluated intervention approach has potential for broad dissemination and reach to reduce cigarette smoking and has implications for cancer prevention because smoking is the primary risk factor for lung cancer, which is the leading cause of cancer death among Hispanic men and is second only to breast cancer among Hispanic women. [ABSTRACT FROM AUTHOR]

Introduction: Although some smokers switch to exclusive use of electronic cigarettes (e-cigarettes), others become dual users of combustible cigarettes and e-cigarettes. Little is known about how the onset of vaping affects the use of and dependence on combustible cigarettes or total nicotine use and dependence, which may influence health-related and cessation outcomes. Using self-report data of current combustible and e-cigarette use and retrospective recall of pre-vaping smoking in a sample of dual users, the aims of this study were (1) to compare pre- and post-vaping number of cigarettes per day and combustible cigarette dependence; (2) to compare pre- and post-vaping total nicotine use frequency (number of vaping sessions and cigarettes smoked per day), and total nicotine dependence; and (3) to examine predictors of nicotine dependence.Methods: We used baseline data from a smoking cessation trial with 2896 dual users. Nicotine use frequency and the Heaviness of Smoking Index were used as measures of nicotine use and dependence, respectively.Results: Participants decreased cigarettes/day from pre- (M = 19.24, SD = 9.01) to post-vaping (M = 11.15, SD = 8.02, p < .0001) and combustible cigarette dependence declined from pre- (M = 3.55, SD = 1.51) to post-vaping (M = 2.11, SD = 1.60, p < .0001). Total daily nicotine use frequency increased after initiating vaping (M = 19.25, SD = 9.01 vs. M = 29.46, SD = 8.61; p < .0001), as did total nicotine dependence (M = 3.55, SD = 1.51 vs. M = 4.68, SD = 1.38; p < .0001). Hierarchical regression analyses indicated that variables associated with greater overall nicotine dependence included: younger age, lower education, more years smoking, higher pre-vaping nicotine dependence, using e-cigarettes more days per month, more puffs per vaping session, higher e-liquid nicotine concentration, and longer vaping history.Conclusions: Dual use leads to a reduction in the number of combustible cigarettes, but total nicotine use and dependence increases.Implications: In dual users, a reduction in smoking following onset of vaping may offer some harm reduction via reduction in cigarette intake. However, the increase in total nicotine use and dependence could affect the ability to quit either or both products. [ABSTRACT FROM AUTHOR]

Highlights • Low-dose CT lung cancer screening is a teachable moment for smoking cessation. • Smoking interventions may be most effective before receiving screening results. • Low cessation self-efficacy was a reported barrier to quitting smoking. • Increased post-cessation survival rates was cited as a motivator to quit. • A self-help smoking intervention was created for low-dose CT screening patients. Abstract Objective The goal of the current study was to develop and examine the feasibility and acceptability of a self-help smoking cessation intervention targeted to the teachable moment of smokers undergoing low-dose computed tomography (LDCT) lung cancer screening. Materials and methods We used a multi-phase qualitative approach, including focus groups (N = 15) and learner verification interviews (N = 16) to develop a targeted intervention for patients receiving a LDCT screening, by extending and modifying a previously validated, self-help intervention. The new intervention was then tested in a feasibility study for acceptability and receptivity by smokers (N = 18) receiving a LDCT screening. Results The main themes that emerged from the focus group findings included a need to address the counterproductive thoughts regarding a negative lung screen result, the desire to enjoy a healthy and smoke-free retirement, the need to increase self-efficacy regarding smoking cessation, and the desire to see statistics regarding survival after quitting smoking. Learner verification findings showed that participants responded favorably to most booklet and pamphlet changes. Minor changes were made to improve comprehension and enhance self-efficacy. Formative findings led to the development of a new initial booklet titled, "Lung Cancer Screening & Quitting Smoking: Taking Control of Your Health," as well as modifications of the existing self-help cessation intervention. The intervention was designed to be initiated at the LDCT appointment, prior to receipt of scan results, and with minimal disruption of clinic work-flow. Results from the feasibility study indicated that acceptability and satisfaction with the new intervention were high. Conclusion A validated self-help smoking-cessation intervention was modified for smokers receiving LDCT screening for lung cancer based on formative research guided by the teachable moment concept. The new intervention is ready for testing in a randomized controlled trial. [ABSTRACT FROM AUTHOR]

Introduction: Varenicline reduces smoking satisfaction during the pre-cessation run-in period, which may contribute to extinction of cravings and smoking behavior. Research indicates that efficacy is enhanced when the run-in period is increased from 1 to 4 weeks, providing a longer extinction opportunity. We hypothesized that efficacy could be further enhanced by harnessing basic and applied research on extinction. We developed a pre-cessation extinction-facilitating intervention and tested its feasibility in a pilot trial.Methods: The facilitated extinction (FE) intervention comprised brief counseling and workbook-recommending strategies to maximize extinction processes during the run-in, including instructions to smoke at a normal rate across contexts and cues, and use of an extinction cue to enhance generalization. Participants were randomly assigned to one of three varenicline interventions: standard (1-week run-in), extended (4-week run-in), and extended + FE. Interventions were delivered prior to the target quit date (TQD). Assessments were conducted in weeks 1 and 4 pre-TQD and 1 and 3 months post-TQD, with focus on feasibility indices.Results: Recruitment and retention goals were met (N = 58). Treatment satisfaction was high across groups. The majority of FE participants adhered to instructions and maintained their usual smoking rate during the run-in period. Greater decreases in craving and smoking satisfaction were observed among participants in both extended groups versus the standard group (p < .005).Conclusions: Feasibility was demonstrated. Participants adhered to the FE intervention, thereby optimizing the number and variety of extinction trials. Findings support testing the novel FE smoking cessation intervention in a fully powered trial.Implications: This study expands the research on the clinical benefits of extending the pre-cessation run-in period of varenicline. It introduces the hypothesis that further benefit might be achieved by translating basic behavioral research, as well as cue-exposure research and therapy for other disorders, to improve the extinction and generalization processes thought to underlie much of varenicline's effect. A FE intervention was developed and found acceptable to smokers and feasible to implement in a research setting. The study sets the stage for a subsequent randomized controlled trial. [ABSTRACT FROM AUTHOR]

Racial/ethnic disparities in tobacco cessation are such that U.S. minorities have greater difficulty quitting compared to White non-Hispanics. Group differences in distress (i.e., perceived stress and depressive symptoms) may contribute to cessation disparities. The allostasis model of health suggests that the toll of chronic stress experienced by racial/ethnic minorities may lead to dysregulation of the physiological stress system and drug use. Previous research suggests that group cognitive behavioral therapy (CBT) for tobacco cessation addresses distress as a modifiable mechanism and has the potential to reduce/eliminate disparities. The present study is a dualsite randomized controlled trial aimed at evaluating the efficacy of group CBT in eliminating racial/ethnic differences in smoking cessation and distress. The study utilizes a [2 (intervention: group CBT or group general health education [GHE]) × 3 (race/ethnicity: African American/Black, Hispanic, White)] factorial design by randomizing 225 adult smokers from the community. Both interventions provide eight counseling sessions and eight weeks of nicotine patch therapy. Assessments occur at the end-of-therapy, and at 3-, 6-, and 12-months. Generalized longitudinal mixed modeling will be used to test our primary abstinence outcome, biochemically-confirmed 7-day point prevalence abstinence at 12-months. We hypothesize that group CBT will reduce or eliminate racial/ethnic differences in perceived stress, depressive symptoms, and smoking cessation compared to group GHE. We also hypothesize that reductions in physiological distress, assessed by salivary cortisol, will mediate racial/ethnic group differences in smoking cessation, particularly among racial/ethnic minorities. This study has implications for eliminating disparities in psychosocial factors related to tobacco use and cessation. Trial registration: Clinicaltrials.gov NCT02511236 . Registered on July 27, 2015. [ABSTRACT FROM AUTHOR]

Smoking-related illnesses are the leading causes of death among Hispanics/Latinos. Yet, there are few smoking cessation interventions targeted for this population. The goal of this study was to "transcreate" an existing, previously validated, English language self-help smoking cessation intervention, titled Forever Free®: Stop Smoking for Good, for Spanish-speaking smokers. Rather than simply translating the materials, our transcreation process involved culturally adapting the intervention to enhance acceptability and receptivity of the information. We utilized a multiphase qualitative approach (focus groups and learner verification interviews) to develop a linguistically and culturally relevant intervention for the diverse sub-ethnic groups of Hispanic/Latino smokers. Focus group findings indicated a need to underscore several additional cultural characteristics and themes such as the need to address familism and unique stressors faced by immigrants and to provide information regarding nicotine replacement therapy. Learner verification findings indicated a need to further emphasize financial and social benefits of quitting smoking and to discuss how family and friends can support the quit attempt. These steps led to the development of a Spanish-language smoking cessation intervention titled, Libre del cigarillo, por mi familia y por mí: Guía para dejar de fumar, that is currently being tested in a national randomized controlled trial. [ABSTRACT FROM AUTHOR]

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products (“dual users”). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users ( N = 2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18 months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3 months over 2 years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. [ABSTRACT FROM AUTHOR]

The combined use of cigarettes and alcohol is associated with a synergistic increase in the risk of morbidity and mortality. Continued alcohol use during a smoking quit attempt is a considerable risk factor for smoking relapse. As such, there is a need for interventions that address both behaviors concurrently. Mindfulness-based interventions hold much promise for simultaneously addressing tobacco and alcohol use. This pilot study evaluated the feasibility and acceptability of a mindfulness-based intervention using a two-arm randomized controlled trial of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) vs Cognitive Behavioral Therapy (CBT). Interventions were delivered via telehealth in a group setting; all participants received a 6-week supply of the nicotine patch. Participants (N = 69) were adults who smoked cigarettes who reported binge drinking and were motivated to both quit smoking and change their alcohol use. Primary outcomes were feasibility and acceptability of MBRP-SA compared to CBT. Changes in tobacco and alcohol use are also presented. Participants in MBRP-SA and CBT indicated that the treatments were highly acceptable, meeting a priori benchmarks. Feasibility was mixed with some outcomes meeting benchmarks (e.g., recruitment) and others falling below (e.g., retention). Participants in both conditions demonstrated significant reductions in tobacco and alcohol use at the end of treatment. In sum, MBRP-SA had comparable outcomes to CBT on all metrics measured. Future research should evaluate the efficacy of MBRP-SA on smoking abstinence and drinking reductions in a large-scale, fully powered trial. This study was registered on clinicaltrials.gov (NCT03734666). • Both MBRP-SA and CBT were highly acceptable, meeting a priori benchmarks. • Both MBRP-SA and CBT had significant reductions in tobacco and alcohol use. • Telehealth was acceptable as a group-treatment delivery modality. • MBRP-SA had comparable outcomes to CBT on all metrics measured. [ABSTRACT FROM AUTHOR]

In the midst of the COVID-19 pandemic, many research and clinical teams have transitioned their projects to a remote-based format, weighing the pros and cons of making such a potentially disruptive decision. One key aspect of this decision is related to the patient population, with underserved populations possibly benefiting from the increased reach of telehealth, while also encountering technology barriers that may limit accessibility. Early in the pandemic, our team shifted a group-based, smoking cessation and alcohol modification treatment trial to a remote-based format. Our population included individuals who concurrently wanted to quit smoking and modify their alcohol use. This paper describes technical and logistical considerations of transitioning from in-person to remote-based delivery for group-based treatment, including the impact upon study staff, group facilitators, participants, and the institution. Remotely-delivered group treatment may be valuable not only in response to pandemic-related restrictions, but it may also offer an alternative treatment-delivery modality with independent benefits in terms of population reach, costs, and pragmatics for clients, staff, and institutions. [ABSTRACT FROM AUTHOR]

The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification. [ABSTRACT FROM AUTHOR]

Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population. [ABSTRACT FROM AUTHOR]