Smoking Cessation Interventions Research Articles

Clinical manifestations of EVALI in adolescents and the impact of e-cigarettes on the respiratory disease

In recent years there has been a significant increase in the popularity of electronic cigarettes among adolescents and young adults worldwide. E-cigarettes have reached the market without the extensive preclinical toxicology testing or long-term safety studies required for conventional therapeutics and medical devices. Their effectiveness as a smoking cessation intervention, their impact at the population level and whether they are less harmful than combustible tobacco products are highly controversial. Studies show measurable adverse biological effects on organ and cell health in humans, animals and in vitro. E-cigarette use also increases the risk of respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. There is a serious risk of complications associated with e-cigarette use, such as EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) - serious lung damage associated with, especially for adolescents. This paper reviews the effects of e-cigarettes on respiratory health.

Correlates of Nicotine Dependence Among Current Cigarette Smokers in Nigeria

BACKGROUND: The level of dependence on nicotine, the main addictive chemical in tobacco, is a substance-related disorder that can be used to characterize diverse populations of cigarette smokers and to determine the effectiveness of individualized smoking cessation intervention programs. AIM: This study aimed to investigate the correlates of nicotine dependence among currently established cigarette smokers in Nigeria. SETTING: We conducted a cross-sectional survey among a cohort of current established cigarette smokers (≥ 100 sticks in a lifetime and someday/everyday cigarette smokers) in Lagos, Nigeria. METHODS: Nicotine dependence (ND) was measured using the Fagerstrom scale; independent measures were demographics, harm perception, binge alcohol drinking, and past year internalizing and externalizing problems. Logistic regression models were used to investigate the factors associated with severe nicotine dependence. RESULTS: The analytical sample was drawn from 487 adults. Within our sample, 69%, 27%, and 3.9% had low, moderate, and severe ND levels, respectively (p = 0.02), whereas among daily cigarette smokers, 48.1%, 44.3%, and 7.6% had low, moderate, and severe ND levels, respectively (p <0.001). In the regression analysis, older age (aOR:1.03; 95% CI:1.01,1.06) and being male (vs. female) (aOR:3.70; 95% CI:1.58,8.15), and reduced cigarette harm perceptions (aOR:2.85; 95% CI: 1.75,4.66) were associated with increased odds of moderate/severe ND. CONCLUSION: Older age, male sex, and those with reduced harm perceptions regarding cigarette use had increased odds of moderate/severe ND. Our preliminary findings provide baseline results characterizing use behaviors among relatively understudied current-established cigarette smokers in Nigeria. CONTRIBUTIONS: All Authors were involved in the conceptualization, data curation, formal analysis, writing–review and editing, and project administration.

Which is a real valuable screening tool for lung cancer and measure thoracic diseases, chest radiography or low-dose computed tomography?: A review on the current status of Japan and other countries.

Chest radiography (CR) has been used as a screening tool for lung cancer and the use of low-dose computed tomography (LDCT) is not recommended in Japan. We need to reconsider whether CR really contributes to the early detection of lung cancer. In addition, we have not well discussed about other major thoracic disease detection by CR and LDCT compared with lung cancer despite of its high frequency. We review the usefulness of CR and LDCT as veridical screening tools for lung cancer and other thoracic diseases. In the case of lung cancer, many studies showed that LDCT has capability of early detection and improving outcomes compared with CR. Recent large randomized trial also supports former results. In the case of chronic obstructive pulmonary disease (COPD), LDCT contributes to early detection and leads to the implementation of smoking cessation treatments. In the case of pulmonary infections, LDCT can reveal tiny inflammatory changes that are not observed on CR, though many of these cases improve spontaneously. Therefore, LDCT screening for pulmonary infections may be less useful. CR screening is more suitable for the detection of pulmonary infections. In the case of cardiovascular disease (CVD), CR may be a better screening tool for detecting cardiomegaly, whereas LDCT may be a more useful tool for detecting vascular changes. Therefore, the current status of thoracic disease screening is that LDCT may be a better screening tool for detecting lung cancer, COPD, and vascular changes. CR may be a suitable screening tool for pulmonary infections and cardiomegaly.

An Age-Progression Intervention for Smoking Cessation: A Pilot Study Investigating the Influence of Two Sets of Instructions on Intervention Efficacy

Abstract Background Research on age-progression facial morphing interventions for smoking cessation has not investigated the effect of different instructions for intervention delivery. The objective of this pilot study was to investigate the influence of two instruction types used to deliver the intervention on efficacy of the intervention. Method Women were recruited and randomly allocated to an age-progression intervention session with (i) neutral instructions; (ii) instructions designed to reassure; or (iii) a condition that controlled for participant engagement (“control”). The conditions were delivered in a one-time procedure, after which primary (quitting intentions) and secondary (cigarettes/week, quit attempts) outcomes were measured immediately post-intervention, and at 1 and 3 months. Results Seventy-two women (M = 25.7; SD = 0.9) were recruited and randomly allocated to condition (Neutral n = 27, Reassuring n = 22, Control n = 23). Quitting intentions were higher in the Reassuring versus Control arm (3 months post-intervention, F = 4.37, p = 0.016, 95% CI [0.231, 2.539], eta2 = 0.11); quit attempts were greater in the two intervention arms (58%) versus Control (1-month post-intervention, 15%) (χ2 = 9.83, p < 0.05, OR 1.00 [0.28, 3.63]). Conclusions Findings highlight the importance of optimising instructions to enhance intervention efficacy. Trial Registration clinicaltrials.gov Record: NCT03749382.

Efficacy of the QuitSure App for Smoking Cessation in Adult Smokers: Cross-Sectional Web Survey.

Cigarette smoking remains one of the leading causes of preventable death worldwide. A worldwide study by the World Health Organization concluded that more than 8 million people die every year from smoking, tobacco consumption, and secondhand smoke. The most effective tobacco cessation programs require personalized human intervention combined with costly pharmaceutical supplementation, making them unaffordable or inaccessible to most tobacco users. Thus, digital interventions offer a promising alternative to these traditional methods. However, the leading smartphone apps available in the market today have either not been studied in a clinical setting or are unable to match the smoking cessation success rates of their expensive offline counterparts. We would like to understand whether QuitSure, a novel smoking cessation app built by Rapidkart Online Private Limited, is able to bridge this efficacy gap and deliver affordable and effective smoking cessation at scale. Our objective was to do an initial exploration into the engagement, efficacy, and safety of QuitSure based on the self-reported experiences of its users. Outcomes measured were program completion, the effect of program completion on smoking behavior, including self-reported cessation outcomes, and negative health events from using the app. All QuitSure registered users who created their accounts on the QuitSure app between April 1, 2021, and February 28, 2022, were sent an anonymized web-based survey. The survey results were added to their engagement data on the app to evaluate the feasibility and efficacy of the app as a smoking cessation intervention. The data were analyzed using descriptive statistics (frequencies and percentages) and the χ2 test of independence. In total, 1299 users who had completed the QuitSure program submitted the survey and satisfied the inclusion criteria of the study. Of these, 1286 participants had completed the program more than 30 days before filling out the survey, and 1040 (80.1%, 95% CI 79.1%-82.6%) of them had maintained prolonged abstinence for at least 30 days after program completion. A majority of participants (770/891, 86.4%) who were still maintaining abstinence at the time of submitting the survey did not experience any severe nicotine withdrawal symptoms, while 41.9% (373/891) experienced no mild withdrawal symptoms either. Smoking quantity prior to completing the program significantly affected quit rates (P<.001), with heavy smokers (>20 cigarettes per day) having a lower 30-day prolonged abstinence rate (relative risk=0.91; 95% CI 90.0%-96.2%) compared to lighter smokers. No additional adverse events outside of known nicotine withdrawal symptoms were reported. The nature of web-based surveys and cohort selection allows for extensive unknown biases. However, the efficacy rates of survey respondents who completed the program were high and provide a case for further investigation in the form of randomized controlled trials on the QuitSure tobacco cessation program.

Effectiveness of a self-determination theory-based smoking cessation intervention plus instant messaging via mobile application for smokers with cancer: Protocol for a pragmatic randomized controlled trial.

Despite evidence that patients living with cancer who continue to smoke after diagnosis are at higher risk for all-cause mortality and reduced treatment efficacy, many cancer patients continue to smoke. This protocol is for a study to test the effectiveness of a self-determination theory-based intervention (quit immediately or progressively) plus instant messaging (WhatsApp or WeChat) to help smokers with cancer to quit smoking. This will be a multi-centre, two-arm (1:1), single-blind, pragmatic, individually randomized controlled trial. Taking part will be specialist outpatient clinics in five major hospitals in different location-based clusters in Hong Kong. The sample will include 1448 Chinese smokers living with cancer attending medical follow-ups at outpatient clinics. The intervention group will receive brief advice (approximately 5-8 minutes) from research nurses in the outpatient clinics and then be invited to choose their own quit schedules (immediate or progressive). During the first 6-month follow-up period they will receive instant messaging with smoking cessation advice once per week for the first 3months, and thereafter approximately once per month. They will also receive four videos, and those opting to quit progressively will receive a smoking reduction leaflet. The control group will also receive brief advice but be advised to quit immediately, and instant messaging with general health advice during the first 6-month follow-up period using the same schedule as the intervention group. Participants in both groups will receive smoking cessation leaflets. The primary outcome is biochemically validated smoking abstinence at 6months, as confirmed by saliva cotinine level and carbon monoxide level in expired air. Secondary outcomes include biochemically validated smoking abstinence at 12 months, self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months, self-reported ≥ 50% reduction of cigarette consumption at 6 and 12 months and quality of life at 6 and 12 months. All time-points for outcomes measures are set after randomization. The results could inform research, policymaking and health-care professionals regarding smoking cessation for patients living with cancer, and therefore have important implications for clinical practice and health enhancement.

Koori Quit Pack: A feasibility study of a multi-component mailout smoking cessation support for Aboriginal and Torres Strait Islander people: "I would recommend it to anybody. It's just so much easier".

Smoking is the leading cause of preventable death among Aboriginal and Torres Strait Islander people. The Koori1 Quit Pack study aimed to assess the feasibility of a multi-component mailout smoking cessation intervention to reduce smoking among Aboriginal and Torres Strait Islander people. A non-randomised, single-group feasibility study conducted among Aboriginal and Torres Strait Islander people who reported current smoking. The intervention package included information pamphlets and resources on quitting, referral offer to Aboriginal Quitline and optional free Nicotine Replacement Therapies (NRT). Follow-up was conducted at 2-weeks, 6-weeks, 10-weeks and 6-months post recruitment. Feasibility outcomes were recruitment and retention rates, uptake of intervention components and smoking abstinence at 6-week follow-up (primary end point). Cessation outcomes were analysed using both a complete case analysis and intention-to-treat approach. 165 participants were recruited, 111 (67.3%), 79 (47.9%), 59 (35.8%), and 94 (57%) participants completed the 2-week, 6-week, 10-week, and 6-month follow-up. At 10-week follow-up, 40.7% of participants used pamphlets and booklets, 13.6% used Quitline and > 90% used NRT. At 6-week follow-up, 87.3% reported a quit attempt and 46.8% sustained quitting. 46.8% were continuously smoke-free at the 6-week timepoint. The complete case analysis and the intention-to-treat analysis at 6-month shows a 7-day self-reported point prevalence abstinence of 34% and 19.4% respectively. The Koori Quit Pack mailout smoking cessation program was feasible to support Aboriginal and Torres Strait Islander people. The intervention resulted in a high smoking cessation rate and should be upscaled, implemented and evaluated nationally. Aboriginal and Torres Strait Islander people are disproportionately impacted by tobacco related harms, however the majority want to quit or wish they never took up smoking. Mailout cessation support is feasible, overcomes access barriers to evidence-based support and increases quitting success. We recommend a national mailout smoking cessation program is implemented for, and by Aboriginal and Torres Strait Islander people to accelerate declines in smoking prevalence to eliminate tobacco related death and disease.

Investigating disparities in smoking cessation treatment for veterans with multiple sclerosis: A national analysis.

Smoking is a risk factor for multiple sclerosis (MS) development, symptom burden, decreased medication efficacy, and increased disease-related mortality. Veterans with MS (VwMS) smoke at critically high rates; however, treatment rates and possible disparities are unknown. To promote equitable treatment, we aim to investigate smoking cessation prescription practices for VwMS across social determinant factors. We extracted data from the national Veterans Health Administration electronic health records between October 1, 2017, and September 30, 2018. To derive marginal estimates of the association of MS with receipt of smoking-cessation pharmacotherapy, we used propensity score matching through the extreme gradient boosting machine learning model. VwMS who smoke were matched with veterans without MS who smoke on factors including age, race, depression, and healthcare visits. To assess the marginal association of MS with different cessation treatments, we used logistic regression and conducted stratified analyses by sex, race, and ethnicity. The matched sample achieved a good balance across most covariates, compared to the pre-match sample. VwMS (n=3320) had decreased odds of receiving prescriptions for nicotine patches ([Odds Ratio]OR=0.86, p<.01), non-patch nicotine replacement therapy (NRT; OR=0.81, p<.001), and standard practice dual NRT (OR=0.77, p<.01), compared to matches without MS (n=13,280). Men with MS had lower odds of receiving prescriptions for nicotine patches (OR=0.88, p=.05), non-patch NRT (OR=0.77, p<.001), and dual NRT (OR=0.72, p<.001). Similarly, Black VwMS had lower odds of receiving prescriptions for patches (OR=0.62, p<.001), non-patch NRT (OR=0.75, p<.05), and dual NRT (OR=0.52, p<.01). The odds of receiving prescriptions for bupropion or varenicline did not differ between VwMS and matches without MS. VwMS received significantly less smoking cessation treatment, compared to matched controls without MS, showing a critical gap in health services as VwMS are not receiving dual NRT as the standard of care. Prescription rates were especially lower for male and Black VwMS, suggesting that under-represented demographic groups outside of the white female category, most often considered as the "traditional MS" group, could be under-treated regarding smoking cessation support. This foundational work will help inform future work to promote equitable treatment and implementation of cessation interventions for people living with MS.

Developing a vape shop-based smoking cessation intervention: a Delphi study.

Providing access to a vape shop-based smoking cessation intervention may simultaneously increase e-cigarette use and increase the effectiveness of e-cigarettes for smoking cessation. The aim of this study was to identify the most important elements of vape shop-based smoking intervention to stakeholders who would be involved in delivering or accessing such an intervention. We conducted a three-round Delphi study of vape shop staff (n=40), stop smoking professionals and tobacco control leads (n=30), and smokers, vapers and dual users (n=30) in the United Kingdom in May-August 2021. In each round participants were asked whether they agreed or disagreed statements related to vape shop-based interventions. Forty-six of 95 statements reached consensus in round one, 29 out of 49 in round two and eight out of 20 in round three. There was support for a vape shop-based intervention across stakeholder groups (96%). There was consensus that the service should comprise both product (98%) and behavioural support (97%), and that quitting vaping should not be a goal of the service (79%). Although there was consensus that there should be some free product provision, there was less consensus as to what this should involve. Views were mostly consistent across stakeholder groups. There was broad consensus on how to deliver a vape shop-based smoking cessation intervention, providing a strong basis for future intervention development and implementation. Challenges around misuse of the service and misperceptions about vaping would need to be addressed for such an intervention to be feasible and effective. Many smokers who make a quit attempt using e-cigarettes purchase their vaping products in vape shops. Delivering vape-shop based smoking cessation interventions could help to maximise the effectiveness of e-cigarettes for quitting smoking. This study used a Delphi approach to identify the most important elements of a vape shop-based intervention among stakeholders. The findings could be used to help develop future interventions.

Impact of the disruption in supply of varenicline since 2021 on smoking cessation in England: A population study.

Varenicline is one of the most effective smoking cessation treatments. Its supply in England was disrupted in July 2021 due to nitrosamine impurities found by its supplier, Pfizer. This study measured the impact of this disruption on smoking cessation in England. The study used repeated cross-sectional surveys conducted monthly, from June 2018 to December 2022. Set in England, it comprised a total of 3024 adults who reported smoking during the past year and had made at least one serious attempt to quit in the past 6months. Generalized additive models analyzed the association of the varenicline supply disruption with the trend in self-reported varenicline use in the most recent quit attempt. We used these results to estimate the population-level impact of the disruption on smoking cessation. Before July 2021, the proportion of past 6-month quit attempts using varenicline was stable at approximately 3.9% [risk ratio (RR)trend = 1.034, 95% confidence interval (CI) = 0.823-1.298]. The trend in varenicline use has changed sharply since the supply disruption (RRΔtrend = 0.297, 95% CI = 0.120-0.738), with prevalence falling by 69.3% per year since; from 4.1% in June 2021 to 0.8% in December 2022. Convergently, National Health Service general practitioner prescribing data reported that just 0.1% of prescriptions for smoking cessation treatments in December 2022 were for varenicline. Assuming that varenicline does not return to the market, we estimate that this could result in ~8400 fewer people stopping smoking for at least 6months, ~4200 fewer long-term ex-smokers and ~1890 more avoidable deaths each year. In England, the disruption in supply of varenicline since 2021 has coincided with a substantial fall in the use of varenicline in attempts to quit smoking.

Financial incentive interventions for smoking cessation among Chinese smokers: study protocol for a cluster randomised controlled trial

IntroductionThere is an urgent issue to relieve the burdens caused by tobacco use through feasible and effective smoking cessation interventions, particularly in a middle-income country with less accessible smoking cessation...

Economic Evaluation of Enhanced vs Standard Varenicline Treatment for Tobacco Cessation

Smoking is the leading preventable cause of death and illness in the US. Identifying cost-effective smoking cessation treatment may increase the likelihood that health systems deliver such treatment to their patients who smoke. To evaluate the cost-effectiveness of standard vs enhanced varenicline use (extended varenicline treatment or varenicline in combination with nicotine replacement therapy) among individuals trying to quit smoking. This economic evaluation assesses the Quitting Using Intensive Treatments Study (QUITS), which randomized 1251 study participants who smoked into 4 conditions: (1) 12-week varenicline monotherapy (n = 315); (2) 24-week varenicline monotherapy (n = 311); (3) 12-week varenicline combination treatment with nicotine replacement therapy patch (n = 314); or (4) 24-week varenicline combination treatment with nicotine replacement therapy patch (n = 311). Study enrollment occurred in Madison and Milwaukee, Wisconsin, between November 11, 2017, and July 2, 2020. Statistical analysis took place from May to October 2023. The primary outcome was 7-day point prevalence abstinence (biochemically confirmed with exhaled carbon monoxide level ≤5 ppm) at 52 weeks. The incremental cost-effectiveness ratio (ICER), or cost per additional person who quit smoking, was calculated using decision tree analysis based on abstinence and cost for each arm of the trial. Of the 1251 participants, mean (SD) age was 49.1 (11.9) years, 675 (54.0%) were women, and 881 (70.4%) completed the 52-week follow-up. Tobacco cessation at 52 weeks was 25.1% (79 of 315) for 12-week monotherapy, 24.4% (76 of 311) for 24-week monotherapy, 23.6% (74 of 314) for 12-week combination therapy, and 25.1% (78 of 311) for 24-week combination therapy, respectively. The total mean (SD) cost was $1175 ($365) for 12-week monotherapy, $1374 ($412) for 12-week combination therapy, $2022 ($813) for 24-week monotherapy, and $2118 ($1058) for 24-week combination therapy. The ICER for 12-week varenicline monotherapy was $4681 per individual who quit smoking and $4579 per quality-adjusted life-year (QALY) added. The ICER for 24-week varenicline combination therapy relative to 12-week monotherapy was $92 000 000 per additional individual who quit smoking and $90 000 000 (95% CI, $15 703 to dominated or more costly and less efficacious) per additional QALY. This economic evaluation of standard vs enhanced varenicline treatment for smoking cessation suggests that 12-week varenicline monotherapy was the most cost-effective treatment option at the commonly cited threshold of $100 000/QALY. This study provides patients, health care professionals, and other stakeholders with increased understanding of the health and economic impact of more intensive varenicline treatment options.

The mediating role of health behaviors in the association between depression, anxiety and cancer incidence: an individual participant data meta-analysis.

Although behavioral mechanisms in the association among depression, anxiety, and cancer are plausible, few studies have empirically studied mediation by health behaviors. We aimed to examine the mediating role of several health behaviors in the associations among depression, anxiety, and the incidence of various cancer types (overall, breast, prostate, lung, colorectal, smoking-related, and alcohol-related cancers). Two-stage individual participant data meta-analyses were performed based on 18 cohorts within the Psychosocial Factors and Cancer Incidence consortium that had a measure of depression or anxiety (N = 319 613, cancer incidence = 25 803). Health behaviors included smoking, physical inactivity, alcohol use, body mass index (BMI), sedentary behavior, and sleep duration and quality. In stage one, path-specific regression estimates were obtained in each cohort. In stage two, cohort-specific estimates were pooled using random-effects multivariate meta-analysis, and natural indirect effects (i.e. mediating effects) were calculated as hazard ratios (HRs). Smoking (HRs range 1.04-1.10) and physical inactivity (HRs range 1.01-1.02) significantly mediated the associations among depression, anxiety, and lung cancer. Smoking was also a mediator for smoking-related cancers (HRs range 1.03-1.06). There was mediation by health behaviors, especially smoking, physical inactivity, alcohol use, and a higher BMI, in the associations among depression, anxiety, and overall cancer or other types of cancer, but effects were small (HRs generally below 1.01). Smoking constitutes a mediating pathway linking depression and anxiety to lung cancer and smoking-related cancers. Our findings underline the importance of smoking cessation interventions for persons with depression or anxiety.

The effects of alcohol use on smoking cessation treatment with nicotine replacement therapy: An observational study

IntroductionConcurrent users of tobacco and alcohol are at greater risk of harm than use of either substance alone. It remains unclear how concurrent tobacco and alcohol use affects smoking cessation across levels of alcohol use and related problems. This study assessed the relationship between smoking cessation and levels of alcohol use problems. Methods59,018 participants received nicotine replacement therapy through a smoking cessation program. Alcohol use and related symptoms were assessed using the Alcohol Use Disorders Identification Test (AUDIT-10) and the AUDIT-Concise (AUDIT-C). The primary outcome was 7-day point prevalence cigarette abstinence (PPA) at 6-month follow-up. We evaluated the association between alcohol use (and related problems) and smoking cessation using descriptive methods and mixed-effects logistic regression. Results7-day PPA at 6-months was lower in groups meeting hazardous alcohol consumption criteria, with the lowest probability of smoking abstinence observed in the highest risk group. The probability of successful tobacco cessation fell with increasing levels of alcohol use and related problems. Adjusted predicted probabilities were 30.3 (95 % CI = 29.4, 31.1) for non-users, 30.2 (95 % CI = 29.4, 31.0) for low-risk users, 29.0 (95 % CI = 28.1, 29.9) for those scoring below 8 on the AUDIT-10, 27.3 (95 % CI = 26.0, 28.6) for those scoring 8–14, and 24.4 (95 % CI = 22.3, 26.5) for those scoring 15 or higher. ConclusionHeavy, hazardous alcohol use is associated with lower odds of successfully quitting smoking compared to low or non-use of alcohol. Targeting alcohol treatment to this group may improve tobacco cessation outcomes.

Hyperlipidemia Prevention and Management Utilizing Lifestyle Changes.

Hyperlipidemia incidence is on the rise and lifestyle behavior change is the first-line therapy. Left untreated, hyperlipidemia can result in cardiovascular disease leading to increased morbidity and mortality in persons worldwide. Evidence has demonstrated behavioral changes such as increased exercise, healthy nutrition, smoking cessation, alcohol abstinence, and other lifestyle modification interventions significantly decrease the incidence and severity of hyperlipidemia. The purpose of this article is to review the evidence of lifestyle interventions in preventing and managing hyperlipidemia and to suggest innovative ways to integrate those techniques into clinical practice. Recommendations on hyperlipidemia specific to pregnancy, polycystic ovary syndrome, and estrogen deficiency are also discussed.

Racial/ethnic minority females smoke more cigarettes after social interaction with others who smoke

The present study investigated the effects of social interaction with others who smoke on daily cigarette use among diverse females via ecological momentary assessment methods. Ninety-eight premenopausal females (29.6% White, 70.4% racial/ethnic minority) who smoke daily reported their social interactions and cigarette use over 35-days. Greater than usual levels of social interaction with others who smoke was associated with increased cigarette use that day among racial/ethnic minority females. Future smoking cessation interventions targeting racial/ethnic minority females should consider the impact of social environments on smoking behaviors, such as the frequency of peer interactions with others who smoke.

Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial

Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs). Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences. Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy. Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.

A qualitative study of using nicotine products for smoking cessation after discharge from residential drug and alcohol treatment in Australia.

Tobacco smoking is highly prevalent among alcohol and other drugs (AOD) service clients and, despite interest in quitting, abstinence is rarely sustained. Nicotine products may assist after discharge from residential treatment services, but little is known about client receptivity to them. This study examined AOD withdrawal service clients' experiences of two types of nicotine products for smoking cessation post-discharge, combination nicotine replacement therapy (cNRT) and nicotine vaping products (NVP). We held semi-structured telephone interviews with 31 Australian AOD service clients in a clinical trial of a 12-week smoking cessation intervention using Quitline support plus cNRT or NVP delivered post-discharge from a smoke-free residential service. We asked about health and social factors, nicotine cravings, Quitline experience, and barriers and facilitators to cNRT or NVP, then thematically analysed data. cNRT and NVP were described by participants as feasible and acceptable for smoking cessation. For most participants, cost limited cNRT access post study, as did difficulty navigating NVP prescription access. Quitline support was valued, but not consistently used, with participants noting low assistance with NVP-facilitated cessation. Participants considered both cessation methods acceptable and socially supported, and sought information on decreasing nicotine use via NVP. AOD service clients highly valued receiving cNRT or NVP with behavioural support for smoking reduction or abstinence. Both interventions were acceptable to service clients. Findings suggest a potential need to examine both whether NVP use should be permitted in this context, and guidance on the individual suitability of cNRT or NVP.

IntEgrating smoking cessation treAtment into usual online psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital)

BackgroundIn the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available. This novel study aims to assess the acceptability and feasibility of an online smoking cessation intervention, and trial procedures, offered alongside online mental health treatment as it offers increased reach to people with common mental health difficulties who smoke. MethodsA two-armed; Intervention (Integrated SilverCloud smoking cessation support) and control group (SilverCloud usual care), pragmatic, randomised controlled feasibility trial. We aim to recruit 500 adult smokers eligible for online mental health treatment. Follow-up will be conducted at 3-months and 6-months. We will assess the acceptability and feasibility of the trial procedures (i.e., recruitment, data completeness, self-reported acceptability and satisfaction) and the intervention (i.e., self-reported quit attempt, engagement with the smoking cessation and mental health programs, smoking cessation medicine and e-cigarette use, self-reported acceptability and satisfaction) and pilot clinical outcomes (i.e., biologically validated smoking abstinence, anxiety, depression, quality of health). ConclusionIf the Trial is successful, a randomised controlled effectiveness trial will follow to examine whether integrated smoking cessation and mental health treatment increases smoking abstinence and improves depression and anxiety compared to usual care.Trial registration: ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149), 02/02/2023.

Adapting a Financial Incentives Intervention for Smoking Cessation with Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study.

Alaska Native and American Indian (ANAI) peoples in Alaska currently experience a disproportionate burden of morbidity and mortality from tobacco cigarette use. Financial incentives for smoking cessation are evidence-based, but a family-level incentive structure has not been evaluated. We used a community-based participatory research and qualitative approach to culturally adapt a smoking cessation intervention with ANAI families. We conducted individual, semi-structured telephone interviews with 12 ANAI adults who smoke, 12 adult family members, and 13 Alaska Tribal Health System stakeholders statewide between November 2022-March 2023. Through content analysis, we explored intervention receptivity, incentive preferences, culturally aligned recruitment and intervention messaging, and future implementation needs. Participants were receptive to the intervention. Involving a family member was viewed as novel and aligned with ANAI cultural values of commitment to community and familial interdependence. Major themes included choosing a family member who is supportive and understanding, keeping materials positive and encouraging, and offering cash and non-cash incentives for family members to choose (e.g., fuel, groceries, activities). Participants indicated that messaging should emphasize family collaboration and that cessation resources and support tips should be provided. Stakeholders also reinforced that program materials should encourage the use of other existing evidence-based cessation therapies (e.g., nicotine replacement, counseling). Adaptations, grounded in ANAI cultural strengths were made to the intervention and recruitment materials based on participant feedback. Next steps include a beta-test for feasibility and a randomized controlled trial for efficacy. This is the first study to design and adapt a financial incentives intervention promoting smoking cessation among Alaska Native or American Indian (ANAI) peoples and the first to involve the family system. Feedback from this formative work was used to develop a meaningful family-level incentive structure with ANAI people who smoke and family members and ensure intervention messaging is supportive and culturally aligned. The results provide qualitative knowledge that can inform future family-based interventions with ANAI communities, including our planned randomized controlled trial of the intervention.