Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

OBJECTIVES: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. METHODS: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. RESULTS: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. CONCLUSIONS: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers.

Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain.

PURPOSE: We developed and piloted a mobile health app to deliver cognitive behavioral therapy for pain (pain-CBT), remote symptom monitoring, and pharmacologic support for patients with pain from advanced cancer. METHODS: Using an iterative process of patient review and feedback, we developed the STAMP + CBT app. The app delivers brief daily lessons from pain-CBT and pain psychoeducation, adapted for advanced cancer. Daily surveys assess physical symptoms, psychological symptoms, opioid utilization and relief. Just-in-time adaptive interventions generate tailored psychoeducation in response. We then conducted a single-arm pilot feasibility study at two cancer centers. Patients with advanced cancer and chronic pain used the app for 2 or 4 weeks, rated its acceptability and provided feedback in semi-structured interviews. Feasibility and acceptability were defined as ≥ 70% of participants completing ≥ 50% of daily surveys, and ≥ 80% of acceptability items rated ≥ 4/5. RESULTS: Fifteen participants (female = 9; mean age = 50.3) tested the app. We exceeded our feasibility and accessibility benchmarks: 73% of patients completed ≥ 50% of daily surveys; 87% of acceptability items were rated ≥ 4/5. Participants valued the app's brevity, clarity, and salience, and found education on stress and pain to be most helpful. The app helped participants learn pain management strategies and decrease maladaptive thoughts. However, participants disliked the notification structure (single prompt with one snooze), which led to missed content. CONCLUSION: The STAMP + CBT app was an acceptable and feasible method to deliver psychological/behavioral treatment with pharmacologic support for cancer pain. The app is being refined and will be tested in a larger randomized pilot study. TRN: NCT05403801 (05/06/2022).

Anxiety Sensitivity and Distress Tolerance in Relation to Smoking Abstinence Expectancies Among Black Individuals Who Smoke.

OBJECTIVE: Black individuals who smoke in the United States experience significant tobacco-related disparities. Although prior work has established that smoking abstinence expectancies play an important role in smoking-related outcomes, few studies have examined potential individual difference factors that may be relevant to smoking abstinence expectancies among Black individuals who smoke. The present study investigated anxiety sensitivity and distress tolerance in relation to smoking abstinence expectancies among a sample of Black individuals who smoke. METHOD: Participants were 86 Black adults who smoke cigarettes daily (M age = 46.07 years, SD = 10.37; 26.7% female). Four separate linear regression analyses were conducted to evaluate the relation between anxiety sensitivity, distress tolerance, and their interaction with each of the four smoking abstinence expectancies (i.e., somatic symptoms, positive consequences, harmful consequences, and negative mood). RESULTS: Results indicated that higher anxiety sensitivity was related to higher somatic symptoms, harmful consequences, and negative mood abstinence expectancies, whereas distress tolerance was related to higher positive consequences. Further, anxiety sensitivity and distress tolerance interacted to confer greater expectancies for the positive consequences of quitting. CONCLUSIONS: The current findings are among the first to document that anxiety sensitivity and distress tolerance are clinically relevant factors to consider when tailoring smoking cessation treatments for Black individuals who smoke. Future research is needed to examine distress tolerance and anxiety sensitivity as longitudinal predictors of smoking abstinence expectancies among Black individuals who smoke.

Associations between morning affect and later-day smoking urges and behavior.

OBJECTIVE: Affective experiences are associated with smoking urges and behavior. Few studies have examined the temporal nature of these associations within a day, such as whether positive and negative affect in the morning are associated with smoking urges and behavior later in the day. METHOD: Participants (N = 63; MAge = 50 years, 48% female; 60% White) were randomized into one of three smoking cessation interventions and answered up to five daily ecological momentary assessments for 28 days during a quit attempt (M = 21.0 days, SD = 7.1). Before analysis, scores for morning positive and negative affect and later-day smoking urges and behavior were calculated. RESULTS: On days when individuals' morning positive affect was higher than usual, later-day smoking urges tended to be lower than usual. In contrast, on days when individuals' morning negative affect was higher than usual, later-day smoking urges tended to be higher than usual, and smoking was more likely. Further, individuals who had higher characteristic morning positive affect tended to have less intense later-day smoking urges, whereas those who tended to have higher characteristic morning negative affect tended to have more intense later-day smoking urges. CONCLUSIONS: Morning positive and negative affect were associated with later-day smoking urges, and morning negative affect was related to later-day smoking behavior. Future research should examine whether interventions that boost positive affect on mornings when it is lower than usual and attenuate negative affect on mornings when it is higher than usual, may reduce the intensity of smoking urges and the likelihood of smoking later in the day. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial.

BACKGROUND: Varenicline and oral nicotine replacement therapy (NRT) have each been shown to increase the likelihood of smoking cessation, but their combination has not been studied. In addition, smoking cessation medication adherence is often poor, thus, challenging the ability to evaluate medication efficacy. OBJECTIVE: This study examined the effects of combined varenicline and oral NRT and smartphone medication reminders on pharmacotherapy adherence and smoking abstinence among adults enrolled in smoking cessation treatment. METHODS: A 2×2 factorial design was used. Participants (N=34) were randomized to (1) varenicline + oral NRT (VAR+NRT) or varenicline alone (VAR) and (2) smartphone medication reminder messages (REM) or no reminder messages (NREM) over 13 weeks. Participants assigned to VAR+REM received varenicline reminder prompts, and those assigned to VAR+NRT+REM also received reminders to use oral NRT. The other 2 groups (VAR+NREM and VAR+NRT+NREM) did not receive medication reminders. Participants were not blinded to intervention groups. All participants received tobacco cessation counseling. Smartphone assessments of smoking as well as varenicline and NRT use (if applicable) were prompted daily through the first 12 weeks after a scheduled quit date. Descriptive statistics were generated to characterize the relations between medication and reminder group assignments with daily smoking, daily varenicline adherence, and daily quantity of oral NRT used. Participants completed follow-up assessments for 26 weeks after the quit date. RESULTS: Participants were predominantly White (71%), and half were female (50%). On average, participants were 54.2 (SD 9.4) years of age, they smoked an average of 19.0 (SD 9.0) cigarettes per day and had smoked for 34.6 (SD 12.7) years. Descriptively, participants assigned to VAR+NRT reported more days of smoking abstinence compared to VAR (29.3 vs 26.3 days). Participants assigned to REM reported more days of smoking abstinence than those assigned to NREM (40.5 vs 21.8 days). Participants assigned to REM were adherent to varenicline on more days compared to those assigned to NREM (58.6 vs 40.5 days), and participants assigned to VAR were adherent to varenicline on more days than those assigned to VAR + NRT (50.7 vs 43.3 days). In the subsample of participants assigned to VAR+NRT, participants assigned to REM reported more days where ≥5 pieces of NRT were used than NREM (14.0 vs 7.4 days). Average overall medication adherence (assessed via the Medication Adherence Questionnaire) showed the same pattern as the daily smartphone-based adherence assessments. CONCLUSIONS: Preliminary findings indicated that smoking cessation interventions may benefit from incorporating medication reminders and combining varenicline with oral NRT, though combining medications may be associated with poorer adherence. Further study is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT03722966; https://classic.clinicaltrials.gov/ct2/show/NCT03722966.

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking remains high in many low- and middle-income countries (LMICs), including the Southeast Asian nation of Cambodia. Smoking is especially hazardous for people with HIV. In Cambodia, approximately 43%-65% of men with HIV and 3%-5% of women with HIV smoke cigarettes. Thus, there is a critical need for cost-effective smoking cessation interventions for Cambodian people with HIV. This paper describes the design, methods, and data analysis plans for a randomized controlled trial assessing the efficacy of a theory-based mobile health smoking cessation intervention in Cambodian people with HIV. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of a mobile health-based automated messaging (AM) intervention versus standard care (SC) in facilitating smoking cessation among Cambodian people with HIV. METHODS: Cambodian people with HIV who currently smoke and are receiving antiretroviral treatment (target, N=800) will be randomized to (1) SC or (2) the AM intervention. SC participants will receive brief advice to quit smoking, written self-help materials, nicotine patches, and will complete weekly app-delivered dietary assessments for 26 weeks. AM participants will receive all SC components (but will complete smoking-related weekly assessments instead of dietary assessments), in addition to a fully automated tailored messaging program driven by the weekly assessments to facilitate smoking cessation. In the Phase-Based Model of smoking cessation, the cessation process is partitioned into 4 phases: motivation, preparation (precessation), cessation (quit date to 2 weeks post quit), and maintenance (up to 6 months post quit). Our AM program targets processes within these phases, including increasing motivation to quit, enhancing self-efficacy, obtaining social support, skills to cope with nicotine withdrawal symptoms and stress, and skills to maintain abstinence. All participants will complete baseline and 3-, 6-, and 12-month in-person follow-up assessments. The primary outcome is biochemically confirmed abstinence at 12 months, with 3- and 6-month abstinence as secondary outcomes. Potential mediators and moderators underlying treatment effects will be explored, and cost-effectiveness will be assessed. RESULTS: This study was approved by all relevant domestic and international institutional and ethical review boards. Participant recruitment commenced in January 2023. Data collection is expected to conclude by the end of 2025. CONCLUSIONS: By demonstrating the greater efficacy and cost-effectiveness of AM relative to SC, this study has the potential to transform HIV care in Cambodia and prevent tobacco-related diseases. Furthermore, it may be adapted for use in other Cambodian populations and in other low- and middle-income countries. Ultimately, the AM approach to smoking cessation could greatly improve public health in the developing world and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT05746442; https://clinicaltrials.gov/ct2/show/NCT05746442. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48923.

Tips to Quit Smoking: Perspectives from Vietnamese Healthcare Providers, Community Leaders, and Past Tobacco Users in the United States.

This study focuses on smoking-cessation strategies for United States (US) Vietnamese individuals, a group with high smoking rates, particularly those with limited English proficiency (LEP). The researchers conducted 16 in-depth interviews with a diverse group of participants, including healthcare professionals, community leaders, and former tobacco users. Data were analyzed using the Phase-Based Model of smoking cessation, resulting in several helpful strategies across the four phases: Motivation, Preparation, Cessation, and Maintenance. Prominent advice for the Motivation Phase included having a strong determination to quit and a reason why, such as protecting loved ones. For the Preparation and Cessation Phases, participants recommended healthy coping mechanisms, avoiding triggers, changing habits, and gradually reducing the number of cigarettes smoked. In the Maintenance Phase, strategies included regular exercise and setting boundaries with other people who smoke. Participants also stressed the importance of social support throughout all four phases. These findings have implications for healthcare providers working with US Vietnamese who smoke, especially those with LEP. By understanding the unique challenges this group faces in accessing smoking-cessation resources, providers can offer tailored support and guidance. Ultimately, this study provides useful strategies for helping US Vietnamese quit smoking, improving their health outcomes and quality of life.

The Indirect Effect of Smoking Level in the Association Between Urban Stress and Readiness to Quit Smoking among Adults Experiencing Homelessness.

Over 70% of adults experiencing homelessness are cigarette smokers, a fivefold greater rate than in the general U.S. population. Consequently, tobacco-related conditions are the leading causes of disease and death for this group. Adults experiencing homelessness tend to seek shelter in urban areas. Thus, they not only experience the daily stressors of being homeless, they may additionally experience unique or additive urban stressors (e.g., stress related to using public services, crime and violence, and/or cultural conflicts with others). For some smokers, stress is known to increase smoking rates and decrease readiness to quit smoking. Likewise, increased smoking rates alone may lead to a lower likelihood of making a quit attempt. The current study examined the potential mediating role of smoking level in the association of urban stress and quit readiness among adults experiencing homelessness (N=411). Two multinomial logistic regression analyses revealed that urban stress was positively associated with smoking level (p = 0.02). The odds ratio for one-unit increase in stress was 1.047 (CI.95:1.014, 1.082) for being a heavy vs. non-daily smoker. Furthermore, analyses revealed smoking level mediated the effect of stress on quit readiness (ab= -0.005, CI.95:-0.010, -0.002]). Homeless smokers who report high levels of stress might smoke at higher levels, which could attenuate quit readiness.

Tobacco advertising exposure and product use among young adults: An ecological momentary assessment approach.

INTRODUCTION: Tobacco-related content is prevalent on social media, yet many methods of measuring exposure are inadequate due to the personalized nature of online marketing. The purpose of this paper is to examine the association between exposure to pro-tobacco messages (both industry-sponsored and user-generated) and the use of tobacco products, as reported via ecological momentary assessment (EMA). METHODS: Young adults (n = 175) were instructed to record all sightings of marketing (both in-person and online) related to tobacco for 28 days. Tobacco product use and recall of message encounters were assessed daily using app-initiated EMA. RESULTS: Participants who reported exposure to tobacco messages were significantly more likely to report using tobacco, adjusting for gender, age, race/ethnicity, baseline use of any tobacco product, and having friends who use tobacco and e-cigarettes (p <.001). For each industry-sponsored message viewed, the odds of using tobacco or e-cigarettes in a given day increased by a factor of 1.77 (95 % CI = 1.41, 2.23). For each user-generated message viewed, the odds of using tobacco or e-cigarettes in a given day increased by a factor of 1.52 (95 % CI = 1.27, 1.83). DISCUSSION: To our knowledge, this is the first study to specifically examine the association between exposure to user-generated messages and daily tobacco use. The findings suggests that there is a unique element to user-generated messages that distinguishes them from both traditional marketing and from simple peer influence.

Daily adherence to nicotine replacement therapy in low-income smokers: The role of gender, negative mood, motivation, and self-efficacy.

BACKGROUND: Low-income smokers may benefit from interventions promoting nicotine replacement therapies (NRTs), particularly for women, as women have worse smoking cessation outcomes than men. Little is known about factors that affect daily NRT adherence, such as negative mood, motivation, and self-efficacy, and whether gender moderates these associations. METHODS: Secondary analysis of a randomized controlled trial comparing a novel, in session sampling of short-acting combination NRT intervention (In Vivo) to standard care smoking cessation behavioral counseling was performed. Low-income smokers (n = 62; Mage = 47.4; 42 % female; 61 % non-White) completed daily surveys using the Insight™ mHealth platform for 55 consecutive days. Three types of NRT adherence were examined: dose amount of short-acting NRT, nicotine patch wear time, and combination NRT (cNRT) (combined nicotine patch and short-acting NRT). RESULTS: Generalized multilevel models report same-day negative mood was associated with greater likelihood of nicotine patch adherence in men, but unrelated to women's nicotine patch adherence. Same-day negative mood was associated with greater likelihood of cNRT adherence in men, but less likelihood in women. The relationship between same-day motivation and use of short-acting NRT varied by gender, but simple slope analyses revealed that motivation was unrelated to short-acting NRT use within either group. Same-day self-efficacy was related to an increased likelihood of nicotine patch adherence and cNRT adherence in women but unrelated to men's adherence of either type. CONCLUSIONS: Future research should focus on gender differences in low-income smokers' same-day negative mood, motivation, and self-efficacy processes on NRT adherence during smoking cessation interventions.

Anxiety sensitivity and reasons for smoking among Black smokers.

Black smokers demonstrate higher nicotine dependence and experience higher rates of smoking-related diseases and mortality relative to European American/White smokers. A potential factor relevant to race-specific smoking health disparities may be smoking motives (i.e., motivational basis of smoking). Yet, little research has been conducted to understand psychological factors that may be associated with specific smoking motives among Black smokers. To address this gap in the literature, the current study explored the association between anxiety sensitivity and smoking motives within a subset sample of Black smokers who were interested in participating in a smoking cessation trial (N = 105; 70.5 % male; Mage = 44.8 years, SD = 11.6 years). Hierarchical regression analyses indicated anxiety sensitivity was associated with smoking motives related to habit (ß = 0.39, p <.001), negative affect reduction (ß = 0.32, p <.001), stimulation (ß = 0.31, p <.001), and sensorimotor manipulation (ß = 0.26, p =.008). Limited support was found for the effect of motives on past quit attempt engagement. These results may broaden understanding of the psychological mechanisms related to smoking motivation among Black smokers and may inform future intervention efforts to reduce smoking motivation among this health disparities population.

A Scoping Review and Meta-analysis of the Use of Remote Biochemical Verification Methods of Smoking Status in Tobacco Research.

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.

Bayesian continuous-time hidden Markov models with covariate selection for intensive longitudinal data with measurement error.

Intensive longitudinal data collected with ecological momentary assessment methods capture information on participants' behaviors, feelings, and environment in near real-time. While these methods can reduce recall biases typically present in survey data, they may still suffer from other biases commonly found in self-reported data (e.g., measurement error and social desirability bias). To accommodate potential biases, we develop a Bayesian hidden Markov model to simultaneously identify risk factors for subjects transitioning between discrete latent states as well as risk factors potentially associated with them misreporting their true behaviors. We use simulated data to demonstrate how ignoring potential measurement error can negatively affect variable selection performance and estimation accuracy. We apply our proposed model to smartphone-based ecological momentary assessment data collected within a randomized controlled trial that evaluated the impact of incentivizing abstinence from cigarette smoking among socioeconomically disadvantaged adults. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Smoking prevalence among Asian Americans: Associations with education, acculturation, and gender.

There is evidence that smoking prevalence rates are related to acculturation, education, and gender among Asian Americans. However, no studies have examined how smoking rates among Asian Americans vary based on acculturation, education, and gender together. This study used National Health Interview Survey (NHIS) data (2010-2018) to examine cigarette smoking prevalence among Asian American men and women aged 18 and older (N = 14,680). Multivariate logistic regression models were used to estimate associations between educational attainment (i.e., college graduate or higher vs some college or lower), years spent in the United States (U.S.) as a proxy for acculturation (i.e., less than 10 years (less acculturated) vs 10 years or more (more acculturated) vs U.S.-born), and cigarette smoking prevalence across gender controlling for age, marital status, poverty (at/above vs below poverty threshold), country of origin (Chinese vs Filipino vs Asian Indian vs Other Asian), and the survey year. Current smoking prevalence was 9.0 % among all Asian Americans - 5.0 % among women and 13.5 % among men. Among respective gender-specific subgroups, U.S.-born Asian women without a college degree and more acculturated Asian immigrant men without a college degree had the highest odds of smoking (OR: 4.096 [95 % CI: 2.638, 6.360] and 1.462 [95 % CI: 1.197, 1.774], respectively). Findings indicated that less educated U.S.-born Asian women and less educated Asian immigrant men are at greatest risk for smoking. Smoking prevalence among Asian Americans is highly related to acculturation, education, and gender. Findings may inform development of policies and programs that are targeted toward smoking cessation among Asian Americans.

Discrimination, Substance Use, and Mental Health among Sexual and Gender Minority Adults Accessing Day Shelter Services.

BACKGROUND: Sexual and gender minority (SGM) adults are overrepresented in the population of individuals experiencing homelessness, and high rates of substance use are common in this group. Plausibly, poor mental health and discrimination may contribute to substance use among SGM adults experiencing homelessness. This study described participant characteristics, and the interrelations among sociodemographic variables, substance use, mental health, and discrimination experiences among 87 SGM adults seeking services at a day shelter in Oklahoma City, OK. Discrimination experiences were characterized by race (White vs. non-White), sex (female vs. male), sexual identity (heterosexual vs. sexual minority), and gender identity (gender conforming vs. gender minority). METHODS: Participants reported their past 30-day tobacco (cigarette/cigarillos, alternative tobacco products [ATP]), alcohol, and marijuana use, as well as everyday and lifetime major discrimination experiences, substance use problems, depression, anxiety, and post-traumatic stress disorder (PTSD). Independent samples t-tests examined differences in discrimination based on substance use and mental health. RESULTS: Participants had high rates of tobacco and marijuana use, substance use problems, depression, anxiety, and PTSD. Over 80% reported experiencing everyday or lifetime major discrimination. Depression and PTSD were associated with ATP use, and anxiety was associated with alcohol use. All mental health variables were associated with substance use problems and everyday discrimination. Depression was associated with lifetime major discrimination. CONCLUSIONS: SGM adults accessing shelter services frequently experienced discrimination and poor mental health, and substance use was common. Future research should examine the causal impact of discrimination on mental health and substance use among SGM adults experiencing homelessness.

An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial.

BACKGROUND: Black smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation. OBJECTIVE: This study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation. METHODS: In phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones. RESULTS: This project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022. CONCLUSIONS: If successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38905.

Quit Stage and Intervention Type Differences in the Momentary Within-Person Association Between Negative Affect and Smoking Urges.

Background: Smoking urges and negative affect play important roles in daily cigarette smoking and smoking lapse during a cessation attempt. Traditionally, laboratory research has considered negative affect as a potential cause of smoking urges. A deeper understanding of momentary associations between negative affect and smoking urges during a smoking cessation attempt can inform treatment development efforts. This study examined whether the within-person association between negative affect and smoking urges differed before and after a quit attempt, and by intervention type. Methods: Data are from a pilot randomized controlled trial comparing 3 smoking cessation interventions. Participants were randomly assigned to: (1) a novel, smartphone-based just-in-time adaptive intervention that tailored treatment content in real-time (Smart-T2; n = 24), (2) the National Cancer Institute QuitGuide app (n = 25), or (3) a clinic-based tobacco cessation program (TTRP; n = 23) that followed Clinical Practice Guidelines. All participants received up to 12 weeks of nicotine replacement therapy and completed up to 5 assessments per day (M PreQuit = 25.8 assessments, SD = 6.0; M PostQuit = 107.7 assessments, SD = 37.1) of their negative affect and smoking urges during the 7 days (M = 6.6 days, SD = 1.0) prior to their quit-date and the 29 days (M = 25.8 days, SD = 6.4) after their quit-date. Prior to analysis, repeated measures of smoking urges were decomposed into between-person and within-person components. Results: After accounting for baseline nicotine dependence, Bayesian multilevel models indicated that the extent of within-person association between negative affect and smoking urges was stronger in the post-quit stage of the intervention than the pre-quit stage. Results also indicated that in the post-quit stage of the intervention, the within-person association between negative affect and smoking urges was weaker for those in the Smart-T2 and TTRP groups compared with those in the QuitGuide group. The extent of this within-person association did not differ between those in the Smart-T2 and TTRP groups. Conclusions: These findings offer preliminary evidence that the momentary within-person association between negative affect and smoking urges increases following a quit attempt, and that the TTRP and Smart-T2 interventions may weaken this association. Research is needed to replicate and expand upon current findings in a fully powered randomized controlled trial. Clinical Trial Registration: ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200.

Perceived Disease Risk of Smoking, Barriers to Quitting, and Cessation Intervention Preferences by Sex Amongst Homeless Adult Concurrent Tobacco Product Users and Conventional Cigarette-Only Users.

Adults experiencing homelessness smoke conventional cigarettes and engage in concurrent tobacco product use at very high rates; however, little is known about how use patterns, perceived disease risk, barriers to quitting smoking, and smoking cessation intervention preferences differ by sex in this group. Participants comprised a convenience sample of 626 adult conventional cigarette smokers experiencing homelessness. Participants self-reported their sex, smoking history, mental health and substance use diagnosis history, other concurrent tobacco product use (CU), disease risk perceptions, perceived barriers to quitting smoking, and preferences regarding tobacco cessation interventions via a computer-administered survey. CU rates were 58.1% amongst men and 45.3% amongst women smokers. In both sexes, CUs started smoking earlier (p-values < 0.001) and were more likely to have been diagnosed with a non-nicotine substance use disorder (p-values < 0.014) relative to cigarette-only users. Among men only, CUs were younger, smoked more cigarettes per day and were more likely to identify as non-Hispanic White (p-values < 0.003) than cigarette-only users. Additionally, male CUs reported a greater risk of developing ≥1 smoking-related disease if they did not quit for good; were more likely to endorse craving cigarettes, being around other smokers, habit, stress/mood swings, and coping with life stress as barriers for quitting smoking; and were less likely to prefer medications to quit smoking relative to male cigarette-only users (p-values < 0.04). On the other hand, female CUs reported a greater risk of developing ≥1 smoking-related disease even if they quit for good; were more likely to endorse stress/mood swings and coping with life stress as barriers for quitting smoking relative to female cigarette-only users (p-values < 0.05); and did not differentially prefer one cessation medication over another. Overall, findings confirm high rates of CU among both sexes, characterize those who may be more likely to be CUs, and reveal opportunities to educate men and women experiencing homeless on the benefits of evidence-based interventions for smoking cessation.

Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial.

BACKGROUND: Smoking is the leading cause of preventable morbidity and mortality in the United States. Individuals with low socioeconomic status have disproportionately high smoking rates and greater difficulty quitting smoking. Efficiently connecting underserved smokers to effective tobacco cessation programs is crucial for disease prevention and the elimination of health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments targeting underserved smokers, but there is little efficacy data for these interventions. In this study, we will partner with a large, local hunger-relief organization to evaluate the efficacy and economic impact of a theoretically-based, fully-automated, and interactive smartphone-based smoking cessation intervention. METHODS: This study will consist of a 2-group randomized controlled trial. Participants (N = 500) will be recruited from a network of food distribution centers in West Central Florida and randomized to receive either Standard Treatment (ST, n = 250) or Automated Treatment (AT, n = 250). ST participants will be connected to the Florida Quitline for telephone-based treatment and will receive a 10-week supply of nicotine replacement therapy (NRT; transdermal patches and lozenges). AT participants will receive 10 weeks of NRT and a fully-automated smartphone-based intervention consisting of interactive messaging, images, and audiovisual clips. The AT intervention period will span 26 weeks, with 12 weeks of proactive content and 26 weeks of on-demand access. ST and AT participants will complete weekly 4-item assessments for 26 weeks and 3-, 6-, and 12-month follow-up assessments. Our primary aim is to evaluate the efficacy of AT in facilitating smoking abstinence. As secondary aims, we will explore potential mediators and conduct economic evaluations to assess the cost and/or cost-effectiveness of ST vs. AT. DISCUSSION: The overall goal of this project is to determine if AT is better at facilitating long-term smoking abstinence than ST, the more resource-intensive approach. If efficacy is established, the AT approach will be relatively easy to disseminate and for community-based organizations to scale and implement, thus helping to reduce tobacco-related health disparities. TRIAL REGISTRATION: Clinical Trials Registry NCT05004662 . Registered August 13, 2021.