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Introduction This scoping review takes stock of the social and behavior change theories that have underpinned tobacco interventions tailored to sexual and/or gender minority (SGM) people and reflects on the need to target contextually based drivers of SGM tobacco use inequities. Aims and Methods Data sources were Medline (Ovid), Scopus, PubMed, and Google Scholar (January 01, 1946 to October 27, 2022). Peer-reviewed publications in English from anywhere in the world describing SGM-tailored tobacco cessation and/or prevention interventions were independently identified by a librarian and screened by the first and third authors. Three hundred and sixty-seven articles were extracted; an additional two were found by hand searching. A total of 369 articles were assessed for eligibility. Exclusion criteria were: Not an intervention, review article, not SGM-tailored, or tobacco-focused. We documented the intervention name, intervention components, theoretical frameworks cited in reference to intervention design and/or implementation, and evaluation outcomes. All authors provided input on theoretical framework categorization. Results We identified 22 publications corresponding to 15 unique interventions. Individual-level behavior change theories (ie, those focusing on within-person behavior change processes) were the most prominent. Among these, the Transtheoretical Model was the most frequently utilized, while Social Inoculation Theory, Theory of Reasoned Action, and Theory of Psychological Reactance were also employed. A minority of interventions referenced frameworks that more explicitly engaged with SGM people’s social contexts, namely, Theory of Diffusion of Innovations and Minority Stress Model. Conclusions Future SGM-tailored tobacco interventions should leverage both the strengths of individual-level behavior change theories and those of frameworks that understand tobacco use inequities as indivisible from place, context, and policy. Implications This scoping review describes the theoretical underpinnings of sexual and/or gender minority (SGM)-tailored tobacco interventions published in the peer-review literature in English. It reflects on the need for greater utilization of social and behavior change theoretical frameworks that can engage with unique drivers of SGM tobacco use and barriers to cessation.

Tailored tobacco cessation interventions focusing on minoritized communities are proliferating, but the extent to which these interventions address the needs of individuals with multiple minoritized social identities is unclear. We developed Empowered, Queer, Quitting, and Living (EQQUAL), an avatar-led digital smoking cessation intervention tailored for lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, and more (LGBTQIA+) young adults based on acceptance and commitment therapy (ACT), via a multistage user-centered design process. The purpose was to evaluate feedback from EQQUAL development activities using an intersectional lens. Intersectionality is a paradigm created by Kimberlé Crenshaw illustrating the multiple social identities each person possesses along with the marginalization of these different social identities. We conducted a rapid deductive content analysis focused on intersectional design gaps using interviewer notes from user testing ( n = 7), a diary study ( n = 8), and treatment satisfaction responses from a single-arm trial of the EQQUAL intervention ( n = 22). Feedback related to intersectional design fell under three broad themes: (a) inadequate representativeness of the avatar, (2) inadequate representativeness within the program broadly, and (3) non-inclusive ACT intervention content. Feedback on inclusiveness included reference to socioeconomic status, race/ethnicity, religious/cultural affiliation, and ability/disability. Although we previously found that EQQUAL was highly acceptable and showed promise in terms of efficacy in a single-arm pilot trial, we identified several gaps in intersectional design as the iterative intervention development proceeded. Because intersectional design is a critical part of developing interventions with a health equity focus, applying standardized procedures for intersectional design and analysis could improve intervention design and better address tobacco cessation treatment needs of individuals who may experience multiple forms of marginalization.

Introduction Increasing digital delivery of smoking cessation interventions has resulted in the need to employ novel strategies for remote biochemical verification. Aims and Methods This scoping review and meta-analysis aimed to investigate best practices for remote biochemical verification of smoking status. The scientific literature was searched for studies that reported remotely obtained (not in-person) biochemical confirmation of smoking status (ie, combustible tobacco). A meta-analysis of proportions was conducted to investigate key outcomes, which included rates of returned biological samples and the ratio of biochemically verified to self-reported abstinence rates. Results A total of 82 studies were included. The most common samples were expired air (46%) and saliva (40% of studies), the most common biomarkers were carbon monoxide (48%) and cotinine (44%), and the most common verification methods were video confirmation (37%) and mail-in samples for lab analysis (26%). Mean sample return rates determined by random-effects meta-analysis were 70% for smoking cessation intervention studies without contingency management (CM), 77% for CM studies, and 65% for other studies (eg, feasibility and secondary analyses). Among smoking cessation intervention studies without CM, self-reported abstinence rates were 21%, biochemically verified abstinence rates were 10%, and 47% of individuals who self-reported abstinence were also biochemically confirmed as abstinent. Conclusions This scoping review suggests that improvements in sample return rates in remote biochemical verification studies of smoking status are needed. Recommendations for reporting standards are provided that may enhance confidence in the validity of reported abstinence rates in remote studies. Implications This scoping review and meta-analysis included studies using remote biochemical verification to determine smoking status. Challenges exist regarding implementation and ensuring high sample return rates. Higher self-reported compared to biochemically verified abstinence rates suggest the possibility that participants in remote studies may be misreporting abstinence or not returning samples for other reasons (eg, participant burden, inconvenience). Remote biochemical confirmation of self-reported smoking abstinence should be included in smoking cessation studies whenever feasible. However, findings should be considered in the context of challenges to sample return rates. Better reporting guidelines for future studies in this area are needed.

BACKGROUND Despite the declining prevalence of cigarette smoking in the United States, socioeconomically disadvantaged veterans receiving care from the Veterans Health Administration have a high prevalence of smoking. Currently, available treatment options for these veterans focus on tobacco users who are ready to quit and have limited reach. Consequently, there is a great need for accessible, effective smoking cessation interventions for veterans at all levels of readiness to quit smoking. OBJECTIVE To address these needs, we developed Vet Flexiquit, a web-based Acceptance and Commitment Therapy program for veterans, and evaluated its acceptability (primary aim), efficacy, and impact on theory-based change processes relative to the National Cancer Institute’s SmokefreeVET program in a pilot randomized controlled trial. METHODS Participants (N=49) were randomized 1:1 to receive either the Vet Flexiquit (n=25) or SmokefreeVET (n=24) web program. Both groups received SMS text messages as part of the intervention for 6 weeks. Both interventions are fully automated and self-guided. Primary outcome data were collected at 3 months after the randomization. Self-reported smoking abstinence was biochemically verified using saliva cotinine. Multivariable logistic regression, negative binomial regression, and linear regression models were used to evaluate the association between the treatment arm and outcomes of interest. RESULTS Acceptability, as measured by overall treatment satisfaction, was high and similar across treatment arms: 100% (17/17) for Vet Flexiquit and 95% (18/19) for SmokefreeVET. Acceptability, as measured by utilization, was more modest (log-ins: M=3.7 for Vet Flexiquit and M=3.2 for SmokefreeVET). There were no statistically significant differences between treatment arms for any acceptability measures. Similarly, there were no statistically significant differences between treatment arms in the secondary outcomes of smoking cessation or change in Acceptance and Commitment Therapy’s theory-based processes. In open-ended survey responses, some veterans in both treatment arms expressed interest in having support from a professional or peer to enhance their experience, as well as an expanded SMS text messaging program. CONCLUSIONS Both programs had high ratings of acceptability, limited utilization, and a similar impact on cessation and cessation processes. Taken together with the qualitative data suggesting that additional support may enhance participants’ experience of both programs, these preliminary findings suggest that the programs may have similar outcomes among veterans who are looking for a digital cessation treatment option and that integrating provider or peer support and enhancing the SMS text messaging program holds promise as a means of boosting engagement and outcomes for both programs. CLINICALTRIAL ClinicalTrials.gov NCT04502524; https://clinicaltrials.gov/ct2/show/NCT04502524

BACKGROUND: Implementation of effective smoking cessation interventions in lung cancer screening has been identified as a high-priority research gap, but knowledge of current practices to guide process improvement is limited due to the slow uptake of screening and dearth of data to assess cessation-related practices and outcomes under real-world conditions. OBJECTIVE: To evaluate cessation treatment receipt and 1-year post-screening cessation outcomes within the largest integrated healthcare system in the USA—the Veterans Health Administration (VHA). Design Observational study using administrative data from electronic medical records (EMR). Patients Currently smoking Veterans who received a first lung cancer screening test using low-dose CT (LDCT) between January 2014 and June 2018. Main Outcomes Tobacco treatment received within the window of 30 days before and 30 days after LDCT; 1-year quit rates based on EMR Smoking Health Factors data 6–18 months after LDCT. Key Results Of the 47,609 current smokers screened (95.3% male), 8702 (18.3%) received pharmacotherapy and/or behavioral treatment for smoking cessation; 531 (1.1%) received both. Of those receiving pharmacotherapy, only one in four received one of the most effective medications: varenicline (12.1%) or combination nicotine replacement therapy (14.3%). Overall, 5400 Veterans quit smoking—a rate of 11.3% (missing=smoking) or 13.5% (complete case analysis). Treatment receipt and cessation were associated with numerous sociodemographic, clinical, and screening-related factors. CONCLUSIONS: One-year quit rates for Veterans receiving lung cancer screening in VHA are similar to those reported in LDCT clinical trials and cohort studies (i.e., 10–17%). Only 1% of Veterans received the recommended combination of pharmacotherapy and counseling, and the most effective pharmacotherapies were not the most commonly received ones. The value of screening within VHA could be improved by addressing these treatment gaps, as well as the observed disparities in treatment receipt or cessation by race, rurality, and psychiatric conditions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07011-0.

Financial worry is an under-appreciated negative effect of cancer. The relationship of financial worry and health behaviors in cancer is poorly characterized and has important clinical implications. This study examined the association of financial worry with substance misuse, mood, and quality of life.People with cancer (n = 1473; 6 to 20 months after diagnosis) were recruited from a SEER cancer registry in the Pacific Northwest. Participants completed an online survey assessing financial worry; misuse of cannabis, alcohol, and prescription drugs; tobacco smoking status; quality of life (physical and mental dimensions); anxiety; and depression. Multivariable regressions tested the association of financial worry to each health indicator and outcome.In adjusted analyses, financial worry was associated with being a current vs. never smoker (odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.01, 3.60), and a positive screen for an anxiety (OR = 3.01, 95% CI: 1.93, 4.68) and depressive (OR = 3.08, 95% CI: 1.89, 5.00) disorder. Financial worry was not associated with cannabis, alcohol, or prescription drug misuse (all ps 0.05), but was associated with a decrease in physical (β = - 2.97, 95% CI: - 4.15, - 1.79) and mental (β = - 5.27, 95% CI: - 6.59, - 3.96) quality of life.Financial worry among cancer survivors is associated with anxiety, depression, and worse quality of life. Of the evaluated substances, there was only an increased odds of current tobacco use with financial worry. Future longitudinal studies should inform the relationships between these factors.Financial worry and material hardship may both need to be addressed in cancer survivorship.

Introduction. Nearly 1 in 10 pregnant women in the U.S. report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as Fetal Alcohol Spectrum Disorders (FASDs). Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI; e-SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3 x 2 factorial trial. Method and analysis. This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 15-minute session, and single session plus two five-minute boosters) with two levels of tailored text messaging (none vs. twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks gestation, and negative results for Ethyl Glucuronide (EtG) analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. Ethics and dissemination. Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. Trial registration number. This trial is registered with ClinicalTrials.gov (registration number: NCT04332172).

Background Lung cancer screening (LCS) is now recommended for people at high risk of dying of lung cancer. Research question The purpose of this study was to use the LCS decision discussion as a case study to understand possible underlying components of a teachable moment to enhance motivation for smoking cessation. Study design and methods The study investigated how patients and clinicians communicate about smoking. In-depth, semi-structured interviews were performed of the experiences of 51 individuals who formerly or currently smoked who were offered LCS and 24 clinicians. Only the baseline interviews were used because including the follow-up interviews would have been beyond the scope of this article. The interviews focused on communication about smoking, the perceived importance of discussing smoking and screening together, and patients' perceived challenges to smoking cessation. Results Patients and clinicians differed in their views on the role of the LCS decision discussion as a teachable moment. Although clinicians felt that this discussion was a good opportunity to positively influence smoking behaviors, neither patients nor clinicians perceived the discussion as a teachable moment affecting smoking behaviors. Other motivating factors for smoking cessation were found. Interpretation Our findings indicate that LCS decision discussions are not currently a teachable moment for behavior change in smoking cessation, but perhaps clinicians could address other aspects of communication to enhance motivation for cessation. Our hypothesized teachable moment model helps explain that there may not be sufficient emotional response elicited during the discussion to motivate a major behavior change such as smoking cessation.

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

This paper reports on topics discussed at a Society for Research on Nicotine and Tobacco pre-conference workshop at the 2019 annual Society for Research on Nicotine and Tobacco meeting. The goal of the pre-conference workshop was to help develop a shared understanding of the importance of several tobacco-related priority groups in tobacco use disorder (TUD) treatment research and to highlight challenges in measurement related to these groups. The workshop focused on persons with minoritized sex, gender identity, and sexual orientation identities; persons with minoritized racial and ethnic backgrounds; persons with lower socioeconomic status (SES); and persons with mental health concerns. In addition to experiencing commercial tobacco-related health disparities, these groups are also underrepresented in tobacco research, including TUD treatment studies. Importantly, there is wide variation in how and whether researchers are identifying variation within these priority groups. Best practices for measuring and reporting sex, gender identity, sexual orientation, race, ethnicity, SES, and mental health concerns in TUD treatment research are needed. This paper provides information about measurement challenges when including these groups in TUD treatment research and specific recommendations about how to measure these groups and assess potential disparities in outcomes. The goal of this paper is to encourage TUD treatment researchers to use measurement best practices in these priority groups in an effort to conduct meaningful and equity-promoting research. Increasing the inclusion and visibility of these groups in TUD treatment research will help to move the field forward in decreasing tobacco-related health disparities. Implications: Tobacco-related disparities exist for a number of priority groups including, among others, women, individuals with minoritized sexual and gender identities, individuals with minoritized racial and ethnic backgrounds, individuals with lower SES, and individuals with mental health concerns. Research on TUD treatments for many of these subgroups is lacking. Accurate assessment and consideration of these subgroups will provide needed information about efficacious and effective TUD treatments, about potential mediators and moderators, and for accurately describing study samples, all critical elements for reducing tobacco-related disparities, and improving diversity, equity, and inclusion in TUD treatment research.

Introduction Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability. Aims and Methods Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions—ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up. Results We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. Conclusions Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation. Implications In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.

Author(s): Ayers, Catherine R; Heffner, Jaimee L; Russ, Cristina; Lawrence, David; McRae, Thomas; Evins, A Eden; Anthenelli, Robert M | Abstract: BackgroundSmoking rates are high in adults with anxiety disorders (ADs), yet little is known about the safety and efficacy of smoking-cessation pharmacotherapies in this group.MethodsPost hoc analyses in 712 smokers with AD (posttraumatic stress disorder [PTSD], n = 192; generalized anxiety disorder [GAD], n = 243; panic disorder [PD], n = 277) and in a nonpsychiatric cohort (NPC; n = 4,028). Participants were randomly assigned to varenicline, bupropion, nicotine-replacement therapy (NRT), or placebo plus weekly smoking-cessation counseling for 12 weeks, with 12 weeks follow-up. General linear models were used to test the effects of treatment group, cohort, and their interaction on neuropsychiatric adverse events (NPSAEs), and continuous abstinence weeks 9-12 (treatment) and 9-24 (follow-up).ResultsNPSAE incidence for PTSD (6.9%), GAD (5.4%), and PD (6.2%) was higher versus NPC (2.1%), regardless of treatment. Across all treatments, smokers with PTSD (odds ratio [OR] = 0.58), GAD (OR = 0.72), and PD (OR = 0.53) had lower continuous abstinence rates weeks 9-12 (CAR9-12) versus NPC. Varenicline demonstrated superior efficacy to placebo in smokers with GAD and PD, respectively (OR = 4.53; 95% confidence interval [CI] = 1.20-17.10; and OR = 8.49; 95% CI = 1.57-45.78); NRT was superior to placebo in smokers with PD (OR = 7.42; 95% CI = 1.37-40.35). While there was no statistically significant effect of any treatment on CAR9-12 for smokers with PTSD, varenicline improved 7-day point prevalence abstinence at end of treatment in this subcohort.ConclusionIndividuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment. While the study was not powered to evaluate abstinence outcomes with these subgroups of smokers with ADs, varenicline provided significant benefit for cessation in those with GAD and PD, while NRT provided significant benefit for those with PD.

BACKGROUND: Lay belief systems about the malleability of human attributes have been shown to impact behavior change in multiple domains. Addiction mindset — i.e., beliefs about the permanence (vs. malleability) of addiction — may affect cigarette smokers’ ability to quit, but this has never been examined. OBJECTIVES: The aims of the present research were to develop a measure of addiction mindset (study 1) and examine its associations with various psychological aspects of quitting smoking (study 2). METHODS: In Study 1, using factor analysis of current smokers’ and non-smokers’ (n=600) responses to 22 items designed to measure addiction mindset, we developed a reliable six-item Addiction Mindset Scale (AMS). In Study 2, adult smokers (n = 200) completed the AMS, and measures of a number of psychological processes related to smoking. RESULTS: Higher scores on the AMS, indicative of the belief that addiction is malleable (referred to as a growth mindset), were positively and significantly associated with greater motivation to quit, greater commitment to quitting, greater self-efficacy to abstain, less attribution of failure to lack of ability to change addiction, and fewer self-reported barriers to cessation (all p’s < .05). CONCLUSIONS: The results of this study show a relationship between the beliefs about the permanence of addiction and psychological processes relevant to quitting smoking. The findings underscore the potential of future research exploring how addiction mindsets relate to successful smoking cessation as well as other types of addictive behavior and how they can be applied to change people’s behavior.

BACKGROUND Sexual and gender minority young adults have a high prevalence of smoking and unique barriers to accessing tobacco treatment. OBJECTIVE To address these challenges as well as their preferences for sexual and gender minority–targeted interventions and digital programs, we developed and evaluated the acceptability, preliminary efficacy, and impact on theory-based change processes of an acceptance and commitment therapy–based digital program called Empowered, Queer, Quitting, and Living (EQQUAL). METHODS Participants (n=22) of a single-arm trial conducted to evaluate the program were young adults, age 18 to 30 years, who self-identified as sexual and gender minority individuals and smoked at least one cigarette per day. All participants received access to the EQQUAL program. Participants completed web-based surveys at baseline and at a follow-up 2 months after enrollment. We verified self-reported smoking abstinence with biochemical testing; missing data were counted as smoking or using tobacco. RESULTS For young adults who logged in at least once (n=18), the mean number of log-ins was 5.5 (SD 3.6), mean number of sessions completed was 3.1 (SD 2.6), and 39% (7/18) completed all 6 sessions. Overall, 93% of participants (14/15) were satisfied with the EQQUAL program, 100% (15/15) found it easy to use, and 100% (15/15) said it helped them be clearer about how to quit. Abstinence from smoking or using tobacco was confirmed with biochemical testing for 23% of participants (5/22). Both quantitative and qualitative results suggested a positive overall response to the avatar guide, with areas for future improvement largely centered on the avatar’s appearance and movements. CONCLUSIONS Treatment acceptability of EQQUAL was very promising. The rate of abstinence, which was biochemically confirmed, was 3 times higher than that of the only other digital program to date that has targeted sexual and gender minority young adults and 6 to 13 times higher than those of nontargeted digital smoking interventions among sexual and gender minority young adults. Planned improvements for the next iteration of the program include making the avatar’s movements more natural; offering multiple avatar guides with different on characteristics such as race, ethnicity, and gender identity from which to choose; and providing a support forum for users to connect anonymously with peers.

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

OBJECTIVE: Evaluate efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) for smoking cessation in smokers with schizophrenia spectrum disorders in post-hoc analyses of EAGLES data. METHODS: Smokers with a schizophrenia spectrum disorder (n=390) and without a psychiatric illness (controls) (n=4,028) were randomly assigned to varenicline, bupropion, NRT, or placebo for 12 weeks. Outcomes included abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events, and temporal relationship between neuropsychiatric adverse events and abstinence status. RESULTS: Smokers with schizophrenia smoked more, had greater dependence, and fewer prior trials of cessation pharmacotherapy. At each timepoint, on varenicline, smokers with schizophrenia had significantly greater odds of abstinence than placebo and comparable NNT with controls. Bupropion and NRT increased odds of abstinence, though confidence intervals included one for some comparisons and produced greater NNT in smokers with schizophrenia than controls. No treatment was associated with significantly more neuropsychiatric adverse events than placebo in either cohort. The estimated neuropsychiatric adverse event rate was 5% (95% CI=3.0–7.7) in smokers with schizophrenia and 1% (95% CI=.6–2.1) in controls. Over one-third of neuropsychiatric adverse events occurred during partial or full abstinence, suggesting a multifactorial nature of neuropsychiatric adverse events. CONCLUSIONS: In smokers with schizophrenia, varenicline was associated with significantly higher abstinence rates than NRT, bupropion, and placebo, and had NNT comparable with smokers without psychiatric disorders. A significant proportion of neuropsychiatric adverse events occurred during early abstinence. No treatment significantly increased neuropsychiatric adverse event prevalence.

IMPORTANCE: Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy. OBJECTIVE: To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG). DESIGN, SETTING, AND PARTICIPANTS: A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant’s 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses. INTERVENTIONS: iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers. MAIN OUTCOMES AND MEASURES: The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization. RESULTS: Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P

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

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

Women and men differ in their risk for developing stress-related conditions such as alcohol use and anxiety disorders and there are gender differences in the typical sequence in which these disorders co-occur. However, the neural systems underlying these gender-biased psychopathologies and clinical course modifiers in humans are poorly understood and may involve both central and peripheral mechanisms regulating the limbic-hypothalamic-pituitary-adrenal axis. In the present randomized, double blind, placebo-controlled, triple-dummy crossover study, we juxtaposed a centrally-acting, citalopram (2 mg/unit BMI) neuroendocrine stimulation test with a peripherally-acting, dexamethasone (Dex) (1.5 mg)/corticotropin-releasing factor (CRF) (1 μg/kg) test in euthymic women (N = 38) and men (N = 44) with (54%) and without histories of alcohol dependence to determine whether sex, alcohol dependence or both influenced the adrenocorticotropic hormone (ACTH) and cortisol responses to the pharmacological challenges and to identify the loci of these effects. We found that central serotonergic mechanisms, along with differences in pituitary and adrenal sensitivity, mediated sexually- diergic ACTH and cortisol responses in a stressor-specific manner regardless of a personal history of alcohol dependence. Specifically, women exhibited a greater response to the Dex/CRF test than they did the citalopram test while men exhibited the opposite pattern of results. Women also had more robust ACTH, cortisol and body temperature responses to Dex/CRF than men, and exhibited a shift in their adrenal glands’ sensitivity to ACTH as measured by the cortisol/log (ACTH) ratio during that session in contrast to the other test days. Our findings indicate that central serotonergic and peripheral mechanisms both play roles in mediating sexually dimorphic, stressor-specific endocrine responses in humans regardless of alcohol dependence history.

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

Introduction: Many barriers exist to integrating smoking cessation into delivery of lung cancer screening including limited provider time and patient misconceptions.Aims: To demonstrate that proactive outreach from a telephone counsellor outside of the patient's usual care team is feasible and acceptable to patients.Methods: Smokers undergoing lung cancer screening were approached for a telephone counselling study. Patients agreeing to participate in the intervention (n = 27) received two telephone counselling sessions. A 30-day follow-up evaluation was conducted, which also included screening participants receiving usual care (n = 56).Results/Findings: Most (89%) intervention participants reported being satisfied with the proactive calls, and 81% reported the sessions were helpful. Use of behavioural cessation support programs in the intervention group was four times higher (44%) compared to the usual care group (11%); Relative Risk (RR) = 4.1; 95% CI: 1.7 to 9.9), and seven-day abstinence in the intervention group was double (19%) compared to the usual care group (7%); RR = 2.6; 95% CI: 0.8 to 8.9).Conclusions: This practical telephone-based approach, which included risk messages clarifying continued risks of smoking in the context of screening results, suggests such messaging can boost utilisation of evidence-based tobacco treatment, self-efficacy, and potentially increase the likelihood of successful quitting.

Background Persistent smoking after a cancer diagnosis predicts worse treatment outcomes and mortality, but access to effective smoking cessation interventions is limited. Smartphone apps can address this problem by providing a highly accessible, low-cost smoking cessation intervention designed for patients with a recent cancer diagnosis. Objective This study aimed to summarize our development process and report the trial design, feasibility, participant acceptability, preliminary effectiveness, and impact on processes of change (eg, cancer stigma) of the first-known smoking cessation smartphone app targeted for cancer patients. Methods We used an agile, user-centered design framework to develop a fully automated smartphone app called Quit2Heal that provided skills training and stories from cancer survivors focusing on coping with internalized shame, cancer stigma, depression, and anxiety as core triggers of smoking. Quit2Heal was compared with the National Cancer Institute’s QuitGuide, a widely used stop smoking app for the general population, in a pilot double-blinded randomized trial with a 2-month follow-up period. Participants were 59 adult smokers diagnosed with cancer within the past 12 months and recruited through 2 cancer center care networks and social media over a 12-month period. The most common types of cancer diagnosed were lung (21/59, 36%) and breast (10/59, 17%) cancers. The 2-month follow-up survey retention rate was 92% (54/59) and did not differ by study arm (P=.15). Results Compared with QuitGuide participants, Quit2Heal participants were more satisfied with their assigned app (90% [19/21] for Quit2Heal vs 65% [17/26] for QuitGuide; P=.047) and were more likely to report that the app assigned to them was made for someone like them (86% [18/21] for Quit2Heal vs 62% [16/26] for QuitGuide; P=.04). Quit2Heal participants opened their app a greater number of times during the 2-month trial period, although this difference was not statistically significant (mean 10.0, SD 14.40 for Quit2Heal vs mean 6.1, SD 5.3 for QuitGuide; P=.33). Self-reported 30-day point prevalence quit rates at the 2-month follow-up were 20% (5/25) for Quit2Heal versus 7% (2/29) for QuitGuide (odds ratio 5.16, 95% CI 0.71-37.29; P=.10). Quit2Heal participants also showed greater improvement in internalized shame, cancer stigma, depression, and anxiety, although these were not statistically significant (all P>.05). Conclusions In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop smoking. Testing in a full-scale randomized controlled trial with a longer follow-up period and a larger sample size is required to test the effectiveness, mediators, and moderators of this promising digital cessation intervention. Trial Registration ClinicalTrials.gov NCT03600038; https://clinicaltrials.gov/ct2/show/NCT03600038

Introduction Sexual and gender minority (SGM) individuals have higher tobacco use prevalence and consequently higher burden of tobacco-caused diseases, including cancer and cardiovascular disease compared with their heterosexual or cisgender counterparts. Yet, there is a critical gap in research focused on measuring SGM tobacco-related health disparities and addressing unmet needs of SGM individuals in the context of nicotine and tobacco research. Aims and Methods In this commentary, we summarize recommendations discussed during a pre-conference workshop focused on challenges and opportunities in conducting SGM tobacco control research at the 2019 Society for Research on Nicotine and Tobacco Annual Meeting. Results Specifically, we recommend defining and measuring SGM identity in all nicotine and tobacco research routinely, using novel methods to engage a demographically diverse sample of the SGM population, and eliciting SGM community voices in tobacco control research. Conclusions Addressing these critical research gaps will enable the scientific community to generate the data to fully understand and support SGM individuals in tobacco use prevention and cessation. Implications Tobacco use and its consequences have become increasingly concentrated in disadvantaged groups, including sexual and gender minority (SGM) populations. Through concrete recommendations in this commentary, we aimed to promote health equity, diversity, and inclusion in tobacco research for SGM populations by urging the scientific community to consider expanding efforts to monitor and address tobacco-related health disparities of SGM populations within their respective research programs.

Background The integration of Behavioral Activation Treatment for Depression (BAT-D) into smoking cessation interventions is a promising approach to address depression as a barrier to quitting. However, this approach has only been tested as a face-to-face intervention, which has low reach. Objective The aims of the study were to develop a BAT-D mobile health app with high potential reach and determine its feasibility, acceptability, and preliminary effects on theory-based behavioral processes of behavioral activation, reduced depressive symptoms, and smoking cessation. Methods Following a user-centered design process consisting of competitive analysis, focus groups, and prototype testing, we conducted a single-arm pilot trial of Actify!, a BAT-D app for depressed smokers. Participants used SmokefreeTXT along with Actify! to provide cessation content that had not yet been built into the app for this initial phase of pilot testing. Participants in the trial were current, daily smokers with mild to moderate depressive symptoms. We examined use outcomes for all enrolled participants and process and cessation outcomes at 6 weeks postenrollment for study completers (16/17, 94% retention). Results Regarding acceptability, average number of log-ins per participant was 16.6 (SD 13.7), and 63% (10/16) reported being satisfied overall with the app. Posttreatment interviews identified some usability challenges (eg, high perceived burden of planning and scheduling values-based activities). There was a significant decrease in depressive symptoms from baseline to follow-up (mean change in Patient Health Questionnaire–9 scores was –4.5, 95% CI –7.7 to –1.3; P=.01). Additionally, carbon monoxide (CO)-confirmed, 7-day point prevalence abstinence (PPA) at 6-week follow-up was 31% (5/16), and the 30-day PPA was 19% (3/16). Conclusions Results demonstrate promising engagement with Actify! and potential for impact on theory-based change processes and cessation outcomes. Preliminary quit rates compare favorably to previous trials of smoking cessation apps for the general population (ie, short-term, self-reported 30-day quit rates in the 8% to 18% range) and a previous trial of face-to-face BAT-D for depressed smokers (ie, CO-confirmed, 7-day PPA rate of 17% at end of treatment).

BACKGROUND Persistent smoking after a cancer diagnosis predicts worse treatment outcomes and mortality, but access to effective smoking cessation interventions is limited. Smartphone apps can address this problem by providing a highly accessible, low-cost smoking cessation intervention designed for patients with a recent cancer diagnosis. OBJECTIVE This study aimed to summarize our development process and report the trial design, feasibility, participant acceptability, preliminary effectiveness, and impact on processes of change (eg, cancer stigma) of the first-known smoking cessation smartphone app targeted for cancer patients. METHODS We used an agile, user-centered design framework to develop a fully automated smartphone app called Quit2Heal that provided skills training and stories from cancer survivors focusing on coping with internalized shame, cancer stigma, depression, and anxiety as core triggers of smoking. Quit2Heal was compared with the National Cancer Institute’s QuitGuide, a widely used stop smoking app for the general population, in a pilot double-blinded randomized trial with a 2-month follow-up period. Participants were 59 adult smokers diagnosed with cancer within the past 12 months and recruited through 2 cancer center care networks and social media over a 12-month period. The most common types of cancer diagnosed were lung (21/59, 36%) and breast (10/59, 17%) cancers. The 2-month follow-up survey retention rate was 92% (54/59) and did not differ by study arm (P=.15). RESULTS Compared with QuitGuide participants, Quit2Heal participants were more satisfied with their assigned app (90% [19/21] for Quit2Heal vs 65% [17/26] for QuitGuide; P=.047) and were more likely to report that the app assigned to them was made for someone like them (86% [18/21] for Quit2Heal vs 62% [16/26] for QuitGuide; P=.04). Quit2Heal participants opened their app a greater number of times during the 2-month trial period, although this difference was not statistically significant (mean 10.0, SD 14.40 for Quit2Heal vs mean 6.1, SD 5.3 for QuitGuide; P=.33). Self-reported 30-day point prevalence quit rates at the 2-month follow-up were 20% (5/25) for Quit2Heal versus 7% (2/29) for QuitGuide (odds ratio 5.16, 95% CI 0.71-37.29; P=.10). Quit2Heal participants also showed greater improvement in internalized shame, cancer stigma, depression, and anxiety, although these were not statistically significant (all P>.05). CONCLUSIONS In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop smoking. Testing in a full-scale randomized controlled trial with a longer follow-up period and a larger sample size is required to test the effectiveness, mediators, and moderators of this promising digital cessation intervention. CLINICALTRIAL ClinicalTrials.gov NCT03600038; https://clinicaltrials.gov/ct2/show/NCT03600038

Lung cancer screening (LCS) is now recommended for people at high risk of dying of lung cancer.The purpose of this study was to use the LCS decision discussion as a case study to understand possible underlying components of a teachable moment to enhance motivation for smoking cessation.The study investigated how patients and clinicians communicate about smoking. In-depth, semi-structured interviews were performed of the experiences of 51 individuals who formerly or currently smoked who were offered LCS and 24 clinicians. Only the baseline interviews were used because including the follow-up interviews would have been beyond the scope of this article. The interviews focused on communication about smoking, the perceived importance of discussing smoking and screening together, and patients' perceived challenges to smoking cessation.Patients and clinicians differed in their views on the role of the LCS decision discussion as a teachable moment. Although clinicians felt that this discussion was a good opportunity to positively influence smoking behaviors, neither patients nor clinicians perceived the discussion as a teachable moment affecting smoking behaviors. Other motivating factors for smoking cessation were found.Our findings indicate that LCS decision discussions are not currently a teachable moment for behavior change in smoking cessation, but perhaps clinicians could address other aspects of communication to enhance motivation for cessation. Our hypothesized teachable moment model helps explain that there may not be sufficient emotional response elicited during the discussion to motivate a major behavior change such as smoking cessation.

BackgroundAlthough smartphone apps have shown promise for smoking cessation, there is a need to enhance their low engagement rates. This study evaluated the application of the growth mindset theory, which has demonstrated the potential to improve persistence in behavior change in other domains, as a means to improve engagement and cessation. ObjectiveThis study aimed to explore the feasibility, utility, and efficacy of a Web-based growth mindset intervention for addiction when used alongside a smoking cessation app. MethodsDaily smokers (N=398) were all recruited on the Web and randomly assigned to receive either a cessation app alone or the app plus a Web-delivered growth mindset intervention. The primary outcome was engagement, that is, the number of log-ins to the smoking cessation app. The secondary outcome was 30-day point prevalence abstinence at 2-month follow-up collected through a Web-based survey. ResultsThe 2-month outcome data retention rate was 91.5% (364/398). In addition, 77.9% (310/398) of the participants in the experimental arm viewed at least 1 page of their growth mindset intervention, and 21.1% (84/398) of the group viewed all the growth mindset intervention. The intention-to-treat analysis did not show statistically significant differences between the experimental and comparison arms on log-ins to the app (19.46 vs 21.61; P=.38). The experimental arm had cessation rates, which trended higher than the comparison arm (17% vs 13%; P=.10). The modified intent-to-treat analysis, including only participants who used their assigned intervention at least once (n=115 in experimental group and n=151 in the control group), showed that the experimental arm had a similar number of log-ins (32.31 vs 28.48; P=.55) but significantly higher cessation rates (21% vs 13%; P=.03) than the comparison arm. ConclusionsA growth mindset intervention for addiction did not increase engagement rates, although it may increase cessation rates when used alongside a smartphone app for smoking cessation. Future research is required to refine the intervention and assess efficacy with long-term follow-up to evaluate the efficacy of the mindset intervention. Trial RegistrationClinicalTrials.gov NCT03174730; https://clinicaltrials.gov/ct2/show/NCT03174730

ObjectivesPost hoc analyses of EAGLES data to examine safety and efficacy of first-line smoking cessation pharmacotherapies in smokers with bipolar disorders (BD).MethodsSmokers with BD I/II (n = 285; 81.4% with BD I) and a comparison nonpsychiatric cohort (NPC; n = 2794) were randomly assigned to varenicline, bupropion, nicotine replacement therapy (NRT), or placebo for 12 weeks, plus weekly counseling. Primary outcomes were occurrence of moderate to severe neuropsychiatric adverse events (NPSAEs) and Weeks 9-12 biochemically-confirmed continuous abstinence (CA) rates.ResultsFor BD smokers, NPSAE risk differences versus placebo were: varenicline, 6.17 (95% CI: -7.84 to 20.18); bupropion, 4.09 (-8.82 to 16.99); NRT, -0.56 (-12.34 to 11.22). ORs for Weeks 9-12 CA, comparing active medication to placebo among BD smokers were: varenicline, 2.61 (0.68-9.95); bupropion, 1.29 (0.31-5.37), NRT, 0.71 (0.14-3.74). Pooling across treatments, NPSAE occurrence was higher (10.7% versus 2.3%; P&nbsp

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

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

The first randomized trial of a smartphone application (app) for adult smoking cessation (SmartQuit 1.0) revealed key features that predict cessation. These findings guided the revision of this AcceptanceCommitment Therapy (ACT)-based application (SmartQuit 2.0), which was primarily tested to examine participant receptivity, short-term cessation and reduction, and the relationship between program completion, smoking cessation and reduction. Secondarily, outcomes were descriptively compared with the SmartQuit1.0 trial.Adult participants (78% female, 25% with high school or less education, 30% unemployed) were recruited into the single-arm pilot trial (N=99) of SmartQuit 2.0 with a two-month follow-up (85% retention).Regarding receptivity, 84% of participants were satisfied with SmartQuit 2.0 (vs. 59% for SmartQuit1.0), 73% would recommend it to a friend (vs. 48% for SmartQuit1.0), 81% found the ACT exercises useful for quitting (vs. 44% for SmartQuit1.0). At the 2-month follow-up, the quit rates were 21% for 7-day point prevalence (vs. 23% for SmartQuit1.0), 11% for 30-day point prevalence (vs. 13% for SmartQuit1.0), and 75% of participants reduced their smoking frequency (vs. 57% for SmartQuit1.0). Among program completers (24% of total sample), the quit rates were 33% for 7-day point prevalence, 28% for 30-day point prevalence, and 88% of participants reduced their smoking frequency.The revised app had high user receptivity, modest quit rates, and high smoking reduction rates. Program completion may be key to boosting the app's effectiveness.

Background Alcohol and nicotine dependence frequently co-occur, and quitting smoking might enhance long-term alcohol abstinence. Topiramate appears to help non-alcohol-dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol-dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug relapse in the context of smoking cessation treatment. Methods One hundred and twenty-nine alcohol-abstinent (mean ~6 months) alcohol-dependent male smokers (80% with other substance use disorders) participated in this 12-week randomized, double blind, parallel group comparison of topiramate (up to 200 mg/d) and placebo with a 24-week nontreatment follow-up period. The study was carried out sequentially at 2 academic centers in the Midwest and Southern California between March 23, 2009 and November 20, 2014. All participants received manual-guided smoking cessation counseling combined with medication-focused compliance enhancement therapy. Randomization was block designed by the research pharmacist in a 1:1 ratio. Participants, investigators, and research personnel were masked to treatment assignment. The primary smoking end point was biochemically confirmed 4-week continuous abstinence from smoking during weeks 9 to 12, while the secondary end point was relapse to any drinking or drug use during the entire 36-week evaluation period. Logistic regression was used to determine the effects of topiramate on quitting smoking and alcohol relapse, controlling for relevant covariates. The trial is registered at ClinicalTrials.gov (number NCT00802412) and is now closed. Results Only a small proportion (7.9%) of topiramate-treated participants were able to quit smoking, and this cessation rate was similar to placebo (10.6%; odds ratio = 1.60; 95% confidence interval 0.4, 6.5; p = 0.51). Roughly 30% of the sample had a documented relapse to drinking or drug use during the study, and these rates were similar in the topiramate (20/63; 31.8%) and placebo groups (18/66; 27.3%; p = 0.58). Results of a longitudinal logistic regression model examining time to any alcohol relapse revealed no medication effect. Conclusions Topiramate at a daily dosage of up to 200 mg per day, combined with smoking cessation and medication adherence counseling, had no effects on smoking cessation or the prevention of alcohol or drug relapse in male smokers who were in early or sustained full remission from alcohol and motivated to make a quit attempt. Alternative approaches for treating this high-risk, dually dependent population are needed.

Although engagement is generally predictive of positive outcomes in technology-based behavioral change interventions, engagement measures remain largely atheoretical and lack treatment-specificity. This study examines the extent to which adherence measures based on the underlying behavioral change theory of an Acceptance and Commitment Therapy (ACT) app for smoking cessation predict smoking outcomes, and user characteristics associated with adherence.Study sample was adult daily smokers in a single arm pilot study (n=84). Using the app's log file data, we examined measures of adherence to four key components of the ACT behavior change model as predictors of smoking cessation and reduction. We also examined baseline user characteristics associated with adherence measures that predict smoking cessation.Fully adherent users (24%) were over four times more likely to quit smoking (OR=4.45; 95% CI=1.13, 17.45; p=0.032). Both an increase in tracking the number of urges passed (OR=1.02; 95% CI=1.00, 1.03; p=0.043) and ACT modules completed (OR=1.27; 95% CI=1.01, 1.60; p=0.042) predicted cessation. Lower baseline acceptance of cravings was associated with over four times higher odds of full adherence (OR=4.59; 95% CI=1.35, 15.54; p=0.014).Full adherence and use of specific ACT theory-based components of the app predicted quitting. Consistent with ACT theory, users with low acceptance were most likely to adhere to the app. Further research is needed on ways to promote app engagement.

Adolescent smoking cessation efforts to date have tended to focus on regular smokers. Consequently, infrequent and occasional smokers' receptivity and response to smoking cessation interventions is unknown. To address this gap, this study examines data from the Hutchinson Study of High School Smoking-a randomized trial that examined the effectiveness of a telephone-delivered smoking cessation intervention for a large, population-based cohort of adolescent smokers proactively recruited in an educational setting.The study population included 1837 proactively identified high school smokers. Intervention receptivity, engagement, and outcomes were examined among adolescent infrequent (1-4days/month) and occasional (5-19days/month) smokers and compared with regular smokers (20 or more days/month).With regard to treatment receptivity, intervention recruitment did not differ by smoking frequency. For engagement, intervention completion rates were higher for infrequent smokers (80.5%) compared with occasional (63.8%) and regular smokers (61.5%, p0.01). Intervention effect sizes were not statistically different across groups.Adolescent infrequent and occasional smokers are at least as receptive to a proactively delivered smoking cessation intervention as regular smokers and can benefit just as much from it. Including these adolescent smokers in cessation programs and research-with the goal of interrupting progression of smoking before young adulthood-should help reduce the high smoking prevalence among young adults.

BACKGROUND The integration of Behavioral Activation Treatment for Depression (BAT-D) into smoking cessation interventions is a promising approach to address depression as a barrier to quitting. However, this approach has only been tested as a face-to-face intervention, which has low reach. OBJECTIVE The aims of the study were to develop a BAT-D mobile health app with high potential reach and determine its feasibility, acceptability, and preliminary effects on theory-based behavioral processes of behavioral activation, reduced depressive symptoms, and smoking cessation. METHODS Following a user-centered design process consisting of competitive analysis, focus groups, and prototype testing, we conducted a single-arm pilot trial of Actify!, a BAT-D app for depressed smokers. Participants used SmokefreeTXT along with Actify! to provide cessation content that had not yet been built into the app for this initial phase of pilot testing. Participants in the trial were current, daily smokers with mild to moderate depressive symptoms. We examined use outcomes for all enrolled participants and process and cessation outcomes at 6 weeks postenrollment for study completers (16/17, 94% retention). RESULTS Regarding acceptability, average number of log-ins per participant was 16.6 (SD 13.7), and 63% (10/16) reported being satisfied overall with the app. Posttreatment interviews identified some usability challenges (eg, high perceived burden of planning and scheduling values-based activities). There was a significant decrease in depressive symptoms from baseline to follow-up (mean change in Patient Health Questionnaire–9 scores was –4.5, 95% CI –7.7 to –1.3; P=.01). Additionally, carbon monoxide (CO)-confirmed, 7-day point prevalence abstinence (PPA) at 6-week follow-up was 31% (5/16), and the 30-day PPA was 19% (3/16). CONCLUSIONS Results demonstrate promising engagement with Actify! and potential for impact on theory-based change processes and cessation outcomes. Preliminary quit rates compare favorably to previous trials of smoking cessation apps for the general population (ie, short-term, self-reported 30-day quit rates in the 8% to 18% range) and a previous trial of face-to-face BAT-D for depressed smokers (ie, CO-confirmed, 7-day PPA rate of 17% at end of treatment).

We sought to qualitatively explore how those at highest risk for lung cancer, current smokers, experienced, understood, and made decisions about participation in lung cancer screening (LCS) after being offered in the target setting for implementation, routine primary care visits. Thirty-seven current smokers were identified within 4 weeks of being offered LCS at seven sites participating in the Veterans Health Administration Clinical Demonstration Project and interviewed via telephone using semi-structured qualitative interviews. Transcripts were coded by two raters and analyzed thematically using iterative inductive content analysis. Five challenges to smokers’ decision-making lead to overestimated benefits and minimized risks of LCS: fear of lung cancer fixated focus on inflated screening benefits; shame, regret, and low self-esteem stemming from continued smoking situated screening as less averse and more beneficial; screening was mistakenly believed to provide general evaluation of lungs and reassurance was sought about potential damage caused by smoking; decision-making was deferred to providers; and indifference about numerical educational information that was poorly understood. Biased understanding of risks and benefits was complicated by emotion-driven, uninformed decision-making. Emotional and cognitive biases may interfere with educating and supporting smokers’ decision-making and may require interventions tailored for their unique needs.

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

Introduction Adults with alcohol dependence (AD) have exceptionally high smoking rates and poor smoking cessation outcomes. Discovery of factors that predict reduced smoking among AD smokers may help improve treatment. This study examined baseline predictors of smoking quantity among AD smokers in a pharmacotherapy trial for smoking cessation. Methods The sample includes male, AD smokers (N = 129) with 1–32 months of alcohol abstinence who participated in a 12-week trial of medication (topiramate vs. placebo) and adjunct counseling with 6 months of follow-up. Baseline measures of nicotine dependence, AD severity, psychopathology, motivation to quit smoking, and smoking-related cognitions were used to predict smoking quantity (cigarettes per day) at post-treatment and follow-up. Results Overall, the sample had statistically significant reductions in smoking quantity. Greater nicotine dependence (Incidence rate ratios (IRRs) = 0.82–0.90), motivation to quit (IRRs = 0.65–0.85), and intrinsic reasons for quitting (IRRs = 0.96–0.98) predicted fewer cigarettes/day. Conversely, greater lifetime AD severity (IRR = 1.02), depression severity (IRRs = 1.05–1.07), impulsivity (IRRs = 1.01–1.03), weight-control expectancies (IRRs = 1.10–1.15), and childhood sexual abuse (IRRs = 1.03–1.07) predicted more cigarettes/day. Conclusions Smokers with AD can achieve large reductions in smoking quantity during treatment, and factors that predict smoking outcomes in the general population also predict greater smoking reductions in AD smokers. Treatment providers can use severity of nicotine dependence and AD, motivation to quit, smoking-related cognitions, and severity of depression to guide treatment and improve outcomes among AD smokers.