Point Prevalence Abstinence Rates Research Articles

Initial Evaluation of Acceptability, Engagement, and Effectiveness of the MO App to Provide Tailored and Comprehensive Support for Smoking Cessation: Development and Usability Study.

Despite the growing availability of smoking cessation apps, low engagement and cessation rates have remained a significant challenge. To address this issue, we used a user-centered design to iteratively develop a mobile app (MO) to provide comprehensive, tailored, and evidence-based content to support smokers in their quitting journey. This study examined the acceptability, use, and preliminary efficacy of the MO app for smoking cessation. Specifically, we sought to understand smokers' preferred features, engagement, and satisfaction with MO; identify concerns in using the app and ways to improve the app; and evaluate its smoking cessation outcomes. Through 3 cohorts, we recruited 10, 12, and 85 adult smokers who attempted to quit smoking to pilot-test the MO app between December 2019 and July 2022. Participants were instructed to complete a baseline survey, interact with the app for 6 weeks, and fill in a postsurvey at week 6. Participants in cohort 3 completed an additional postsurvey at week 12. Participants' app use was tracked and analyzed. The primary outcome measures were participants' 7-day point prevalence abstinence at 6 and 12 weeks. Participants reported high levels of satisfaction with the MO app across all 3 cohorts, rating it between 4.40 and 4.76 on a scale of 5 for acceptability. Users engaged with app activities for an average of 89 to 159 times over 35 days. The most liked features of the app included "quit plan," "tracking," "reminders and notifications," "MOtalks," and "motivational quotes." The 7-day point prevalence abstinence rate of the modified intention to treat population in cohort 3 was 58% at 6 weeks and 52% at 12 weeks. Those who interacted more frequently with app features and engaged with more diverse activities were more likely to maintain abstinence at weeks 6 and 12. For each additional time logged into the app, the odds of staying abstinent at week 12 increased by 5% (odds ratio [OR] 1.05, 95% CI 1.01-1.08). Participants who earned >5000 points during app use also had higher odds of quitting at both 6 weeks (OR 3.12, 95% CI 1.25-7.75) and 12 weeks (OR 4.65, 95% CI 1.83-11.76), compared with those who earned <5000 points. Our study demonstrated that MO is a feasible mobile phone app with high acceptability and usability and can effectively deliver smoking cessation support to individuals who want to quit. Implications for developing and evaluating mobile phone apps for smoking cessation are discussed.

A Vaping Cessation Text Message Program for Adolescent E-Cigarette Users

E-cigarettes are the most commonly used tobacco product among adolescents. Despite known harms of nicotine exposure among teens, there are no empirically tested vaping cessation interventions. To compare the effectiveness of a text message program for nicotine vaping cessation among adolescents with assessment-only control. A parallel, 2-group, double-blind, individually randomized clinical trial with follow-ups at 1 and 7 months after randomization was conducted from October 1, 2021, to October 18, 2023. Participants were recruited via social media ads; the intervention was delivered via text message; and assessments were completed online or by telephone. Eligible individuals were US residents aged 13 to 17 years who reported past 30-day e-cigarette use, were interested in quitting within 30 days, and owned a mobile phone with an active text message plan. To optimize study retention, all participants received monthly assessments via text message about e-cigarette use. Assessment-only controls (n = 744) received only study retention text messages. Intervention participants (n = 759) also received an automated, interactive text message program for vaping cessation that delivers cognitive and behavioral coping skills training and social support. The primary outcome was self-reported 30-day point-prevalence abstinence from vaping at 7 months analyzed as intention-to-treat, with missingness coded as vaping. Among n = 1503 adolescents randomized, average age was 16.4 (SD, 0.8) years. The sample was 50.6% female, 42.1% male, and 7.4% nonbinary/other; 10.2% Black/African American, 62.6% White, 18.5% multiracial, and 8.7% another race; 16.2% Hispanic; 42.5% sexual minority; and 76.2% vaped within 30 minutes of waking. The 7-month follow-up rate was 70.8%. Point-prevalence abstinence rates were 37.8% (95% CI, 34.4%-41.3%) among intervention participants and 28.0% (95% CI, 24.9%-31.3%) among control participants (relative risk, 1.35 [95% CI, 1.17-1.57]; P < .001). No baseline variables moderated the treatment-outcome relationship. There was no evidence that adolescents who quit vaping transitioned to combustible tobacco products. A tailored, interactive text message intervention increased self-reported vaping cessation rates among adolescents recruited via social media channels. ClinicalTrials.gov Identifier: NCT04919590.

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-based peer group mobile messaging smoking cessation intervention. This study aims to assess the feasibility, acceptability, and preliminary effects of WeChat Quit Coach. We enrolled a total of 60 Chinese immigrant smokers in 2022 in New York City for a pilot randomized controlled trial (RCT) and a single-arm pilot test. The first 40 participants were randomized to either the intervention arm (WeChat Quit Coach) or the control arm (self-help print material) using 1:1 block randomization stratified by sex. WeChat Quit Coach lasted 6 weeks, featuring small peer groups moderated by a coach, daily text messages with text questions, and chat-based instant messaging support from the coach in response to peer questions. The next 20 participants were enrolled in the single-arm pilot test to further assess intervention feasibility and acceptability. All 60 participants were offered a 4-week supply of complimentary nicotine replacement therapy. Surveys were administered at baseline and 6 weeks, with participants in the pilot RCT completing an additional survey at 6 months and biochemical verification of abstinence at both follow-ups. Of 74 individuals screened, 68 (92%) were eligible and 60 (88%) were enrolled. The majority of participants, with a mean age of 42.5 (SD 13.8) years, were male (49/60, 82%) and not ready to quit, with 70% (42/60) in the precontemplation or contemplation stage at the time of enrollment. The pilot RCT had follow-up rates of 98% (39/40) at 6 weeks and 93% (37/40) at 6 months, while the single-arm test achieved 100% follow-up at 6 weeks. On average, participants responded to daily text questions for 25.1 days over the 42-day intervention period and 23% (9/40) used the chat-based instant messaging support. Most participants were satisfied with WeChat Quit Coach (36/39, 92%) and would recommend it to others (32/39, 82%). At 6 months, self-reported 7-day point prevalence abstinence rates were 25% (5/20) in the intervention arm and 15% (3/20) in the control arm, with biochemically verified abstinence rates of 25% (5/20) and 5% (1/20), respectively. WeChat Quit Coach was feasible and well-received by Chinese immigrants who smoke and produced promising effects on abstinence. Large trials are warranted to assess its efficacy in promoting abstinence in this underserved population. ClinicalTrials.gov NCT05130788; https://clinicaltrials.gov/study/NCT05130788.

Efficacy and safety of cytisine versus nortriptyline for smoking cessation: A multicentre, randomized, double-blinded and placebo-controlled trial.

Cytisine serves as an affordable smoking cessation aid with acceptable safety profile. However, data comparing its efficacy and safety to standard therapies are limited. We aimed to examine efficacy and safety of cytisine compared to nortriptyline, which is the only approved smoking-cessation medication in Thailand. A 12-month, multicentre, randomized, double-blinded, placebo-controlled trial was conducted. Participants aged ≥20 years who smoked ≥10 cigarettes/day were randomly assigned to receive a 25-day cytisine or a 12-week nortriptyline treatment course. Brief interventions (BI) for smoking cessation were provided to all participants. The primary outcome was biochemically verified continuous abstinence rate (CAR) at 12 months. Additionally, self-reported abstinence, verified by exhaled carbon monoxide (CO) ≤ 10 ppm, was collected at 2 weeks, 1, 3, 6 and 12 months to assess both CAR and 7-day point prevalence abstinence rate (PAR). A total of 1086 participants were recruited and randomized into cytisine (n = 540) and nortriptyline (n = 546) groups. The 12-month CAR was 12.22% for cytisine and 9.52% for nortriptyline. The relative difference was 0.03 (95% confidence interval [CI]; -0.01 to 0.06) and the relative risk was 1.28 (95% CI; 0.91-1.81). No differences were observed in secondary outcomes between both groups. The incidence of adverse effects from cytisine appeared to be lower than that of nortriptyline. At 12 months, cytisine plus BI was as effective as nortriptyline plus BI for smoking cessation. The adverse events for both cytisine and nortriptyline were minimal and well-tolerated.

Interactive assistance via eHealth for small- and medium-sized enterprises’ employer and health care manager teams on tobacco control (eSMART-TC): A cluster randomized hybrid type II trial (N-EQUITY2101/J-SUPPORT2102).

10606 Background: Organizational commitment and consistent leadership are crucial to facilitate implementation of workplace wellness programs. We aimed to investigate whether interactive assistance for SME managers to implement tobacco control programs (compared with usual practice) would increase 6-month abstinence rates in tobacco-smoking employees. Methods: This hybrid type II cluster randomized effectiveness implementation trial was done in Japan. SMEs in the intervention group received interactive assistance to employers and health managers for 6 months by supporting employees through campaigns, tailored ongoing facilitation, and ensuring executive engagement and support, aiming to promote utilization of reimbursed smoking cessation treatments and implement smoke-free workplaces. SMEs in the control group received feedback on the results of the baseline survey and information on smoking cessation measures. Stratified randomization was used to allocate SMEs to either group. The primary outcome was salivary cotinine-validated 7-day point-prevalence abstinence rate at 6 months, and the key secondary outcome was the adoption score of the two recommended measures (promote smoking cessation standard treatment visits, and smoke-free policy) at each SME at 6 months (range: 0–2). Other secondary outcomes included implementation and process outcomes (e.g., proportion of smoking cessation treatment use). Results: Between July 1, 2021, and May 16, 2022, 38 SMEs enrolled. Twenty SMEs were randomly assigned to the intervention group and 18 SMEs to the control group. Among 2,929 employees enrolled, 2,556 responded the baseline survey (response rate: 87.3%; men 65.0%; mean age 44.8 years) and 713 of them (27.9%) indicated being a current smoker in the baseline. Then 176 (6.9%) were omitted because of missing primary outcome data (mainly owing to not responding, turnover, resignation, or retirement); therefore, 537 participants (21.0%) were included in the intention-to-treat based analyses of the primary outcome. At 6 months, the validated 7-day point-prevalence abstinence rate in the intervention group was significantly higher than that in the control group (11.2% vs 4.6%; difference = 6.6%, 95% confidence interval: 2.2%–11.1%, p=0.004). Regarding the analysis for key secondary outcomes, all randomized SMEs were included. At 6 months, adoption score of the two recommended measures was also significantly higher than that in the control group (1.5 vs 1.1; difference = 0.4, 95% confidence interval: 0.01–0.86, p=0.047). Conclusions: Interactive support for SME managers to implement tobacco control measures (compared with usual practice) can accelerate the implementation of evidence-based smoking cessation measures and significantly increase 6-month abstinence rates. Clinical trial information: UMIN000044526.

Evaluation of effectiveness and acceptability of a psychological treatment for smoking cessation combined with a smartphone App: A pilot study

Despite the increasing number of mobile-based interventions to quit smoking over the last years, few studies have investigated the efficacy of smoking cessation interventions blended with smartphone Apps. The present pilot study aims to examine the preliminary effectiveness and acceptability of a cognitive-behavioral treatment combined with a smartphone App, compared to the same psychological treatment without the App. The sample comprised 206 treatment-seeking smokers, who were assigned to: 1) an experimental group receiving a cognitive-behavioral intervention combined with the “Non Fumo” App (n = 102), and 2) a control group receiving only the cognitive-behavioral intervention to quit smoking (n = 104). Results concerning the primary outcomes showed no significant differences between conditions in point-prevalence abstinence rates at 12-month follow-up (35.30 % in the experimental group vs. 31.70 % in the control group) and in treatment acceptability. Regarding the secondary outcomes, both groups obtained similar point-prevalence abstinence rates at the end of treatment (61.80 % vs. 65.40 %), at 3-month (42.20 % vs. 45.20 %, respectively) and 6-month follow-ups (37.30 % vs. 37.50 %). No significant differences were found between conditions in prolonged abstinence rates at 6-month (35.3 % vs. 35.6 %) and 12-month follow-ups (30.4 % vs. 26.9 %). Overall, good abstinence rates and treatment acceptability were obtained, although there were no significant differences between conditions. More research is needed to establish clear conclusions about the efficacy of psychological smoking cessation treatments blended with smartphone Apps.

Contingency management for smoking cessation for individuals with overweight or obesity: A randomized controlled trial

BackgroundInterventions for quitting smoking and weight control among individuals with excess weight are scarce. Our study evaluated the effectiveness of cognitive behavioral therapy (CBT) plus contingency management (CM) in this population, and examined whether CM for smoking cessation improved CBT treatment outcomes at end of treatment (EOT) and at 1-, 3-, 6-, and 12-month follow-ups (FU). MethodsIn an 8-week randomized clinical trial, 120 adults who smoke with overweight or obesity (54.16% females; MBMI = 31.75 ± 4.31) were randomly assigned to CBT for both quitting smoking and weight control (n = 60) or the same treatment plus CM for smoking cessation (n = 60). Outcome variables were compared (i.e., treatment completion, smoking abstinence, weight change and secondary outcomes). ResultsAt EOT, the CBT + CM group achieved 78.33% 7-day point-prevalence abstinence rates compared to 61.67% in the CBT group (p = .073), and rates declined over time (12-month FU: 18% vs 12%). Participants who attained abstinence weighed more compared to baseline at EOT (Mkg = 1.07; SD = 1.88) and over time (12-month FU: Mkg = 4.19; SD = 4.31). No differences were found between the two groups in outcome variables. ConclusionsBoth interventions were effective in promoting abstinence and reducing tobacco use over time. Combining CBT with CM for smoking cessation did not improve treatment outcomes in individuals with overweight or obesity compared to CBT only. Future studies should evaluate whether implementing CM for weight maintenance helps control post-cessation weight gain in this population.

Preliminary Efficacy of a Cognitive Behavioral Therapy-Based Smartphone App for Smoking Cessation in China: Randomized Controlled Pilot Trial.

The overall prevalence of cigarette smokers in China is very high, and China's total cigarette consumption makes up more than 40% of the world's consumption. In view of the lack of smoking cessation services and social support in China and the effectiveness of mobile phone apps for quitting smoking in other countries, we carried out a smartphone app-based smoking cessation trial in China. This study aimed to evaluate the efficacy of a cognitive behavioral therapy (CBT)-based smoking cessation smartphone app among smokers seeking treatment in China. We conducted a randomized controlled, web-based pilot clinical trial in China between February 23 and June 27, 2021. Eligible participants were randomly assigned to the smoking cessation app intervention group or the control group in a ratio of 1:1. The intervention group received the CBT smoking cessation intervention using a smartphone app, and the control group received a "thank you" message. The intervention was 4 weeks long, and the patients were followed up for 4 weeks. The primary outcome was self-reported continuous smoking abstinence at week 4 after the quit date. The secondary outcomes included self-reported 7-day point prevalence of smoking abstinence; reduction of the number of cigarettes smoked per day at weeks 1, 2, 3, and 4; and program acceptability. A total of 973 people were recruited to quit smoking, of whom 262 completed basic information, 56 were excluded, and 206 were randomized and included in the final analysis. There were 189 (91.7%) men and 17 (8.3%) women, with an average age of 34.46 (SD 7.53) years and an average daily smoking rate of 15.93 (SD 7.10) cigarettes/day. We found 30 (29.7%) of the 101 participants in the intervention group and 7 (6.7%) of the 105 participants in the control group reported continuous smoking cessation after the quit date at week 4 (odds ratio 5.92, 95% CI 3.78-9.26; P<.001). The 7-day point prevalence abstinence rate of the intervention group varied from 42.6% (43/101) to 46.5% (47/101) after 1, 2, 3, and 4 weeks, while the control group varied from 18.1% (19/105) to 26.7% (28/105). Compared to the control group, continued smokers consumed 1.5-3.0 fewer cigarettes per day in the intervention group. The overall program got positive user feedback with a high satisfaction rate (66/87, 76%) and an average Mobile Application Rating Scale user version score of 3.46. Our pilot study provided preliminary evidence that the CBT-based smoking cessation smartphone app led to improved smoking quit rates versus control in Chinese smokers. The study demonstrated the CBT-based smartphone app may be an effective and feasible digital treatment model to help smokers quit, which may improve smoking cessation service quality and accessibility in China. ClinicalTrials.gov NCT04421170; https://clinicaltrials.gov/study/NCT04421170. RR2-10.1136/bmjopen-2020-041985.

Conversational Chatbot for Cigarette Smoking Cessation: Results From the 11-Step User-Centered Design Development Process and Randomized Controlled Trial.

Conversational chatbots are an emerging digital intervention for smoking cessation. No studies have reported on the entire development process of a cessation chatbot. We aim to report results of the user-centered design development process and randomized controlled trial for a novel and comprehensive quit smoking conversational chatbot called QuitBot. The 4 years of formative research for developing QuitBot followed an 11-step process: (1) specifying a conceptual model; (2) conducting content analysis of existing interventions (63 hours of intervention transcripts); (3) assessing user needs; (4) developing the chat's persona ("personality"); (5) prototyping content and persona; (6) developing full functionality; (7) programming the QuitBot; (8) conducting a diary study; (9) conducting a pilot randomized controlled trial (RCT); (10) reviewing results of the RCT; and (11) adding a free-form question and answer (QnA) function, based on user feedback from pilot RCT results. The process of adding a QnA function itself involved a three-step process: (1) generating QnA pairs, (2) fine-tuning large language models (LLMs) on QnA pairs, and (3) evaluating the LLM outputs. We developed a quit smoking program spanning 42 days of 2- to 3-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing Food and Drug Administration-approved cessation medications, coping with triggers, and recovering from lapses and relapses. In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to the National Cancer Institute's SmokefreeTXT text messaging program, particularly among those who viewed all 42 days of program content: 30-day, complete-case, point prevalence abstinence rates at 3-month follow-up were 63% (39/62) for QuitBot versus 38.5% (45/117) for SmokefreeTXT (odds ratio 2.58, 95% CI 1.34-4.99; P=.005). However, Facebook Messenger intermittently blocked participants' access to QuitBot, so we transitioned from Facebook Messenger to a stand-alone smartphone app as the communication channel. Participants' frustration with QuitBot's inability to answer their open-ended questions led to us develop a core conversational feature, enabling users to ask open-ended questions about quitting cigarette smoking and for the QuitBot to respond with accurate and professional answers. To support this functionality, we developed a library of 11,000 QnA pairs on topics associated with quitting cigarette smoking. Model testing results showed that Microsoft's Azure-based QnA maker effectively handled questions that matched our library of 11,000 QnA pairs. A fine-tuned, contextualized GPT-3.5 (OpenAI) responds to questions that are not within our library of QnA pairs. The development process yielded the first LLM-based quit smoking program delivered as a conversational chatbot. Iterative testing led to significant enhancements, including improvements to the delivery channel. A pivotal addition was the inclusion of a core LLM-supported conversational feature allowing users to ask open-ended questions. ClinicalTrials.gov NCT03585231; https://clinicaltrials.gov/study/NCT03585231.

Racial/Ethnic Disparities Impact the Real-World Effectiveness of a Multicomponent Maternal Smoking Cessation Program: Findings from the CTTP Cohort.

Smoking during pregnancy adversely affects perinatal outcomes for both women and infants. We conducted a retrospective cohort study of the state-funded Comprehensive Tobacco Treatment Program (CTTP) - the largest maternal tobacco cessation program in San Bernardino County, California - to determine the real-world program effectiveness and to identify variables that can potentially improve effectiveness. During 2012-2019, women who smoked during pregnancy were enrolled in CTTP's multicomponent behavioral smoking cessation program that implemented components of known efficacy (i.e., incentives, biomarker testing, feedback, and motivational interviewing). We found that 40.1% achieved prolonged abstinence by achieving weekly, cotinine-verified, 7-day abstinence during 6 to 8 weeks of enrollment. Using intention-to-treat analyses, we computed that the self-reported point prevalence abstinence rate (PPA) at the six-month telephone follow-up was 36.7%. Cohort members achieving prolonged abstinence during the CTTP were five times more likely to achieve PPA six months after CTTP. Several non-Hispanic ethnicities (Black, Native American, White, or More than one ethnicity) in the cohort were two-fold less likely (relative to Hispanics) to achieve prolonged abstinence during CTTP or PPA at six months after CTTP. This disparity was further investigated in mediation analysis. Variables such as quitting during the first trimester and smoking fewer cigarettes at enrollment were also associated with achieving PPA at six months. Racial/ethnic health disparities that have long been linked to a higher rate of maternal smoking persist even when the pregnant smoker enrolls in a smoking cessation program.

Interactive assistance via eHealth for small- and medium-sized enterprises’ employer and health care manager teams on tobacco control (eSMART-TC): protocol for a cluster randomized hybrid type II trial (N-EQUITY2101/J-SUPPORT2102)

BackgroundTobacco control should be a higher public health priority in Japan. Some workplaces provide smoking cessation support and connect employees to effective smoking cessation treatments such as outpatient clinics. However, tobacco control measures have not been sufficiently implemented in Japan, especially in small- and medium-sized enterprises (SMEs), where resources are limited. Organizational commitment and consistent leadership are crucial to facilitate implementation, but research on whether supporting organizational leaders leads to health behavior changes among employees is limited.MethodsThis hybrid type II cluster randomized effectiveness implementation trial (eSMART-TC) aims to examine the effects of interactive assistance for SME management on health and implementation outcomes. We will provide interactive assistance to employers and health managers for 6 months, aiming to promote the utilization of reimbursed smoking cessation treatments by public health insurance and to implement smoke-free workplaces. The intervention will consist of three strategies: supporting employees through campaigns, tailored ongoing facilitation, and ensuring executive engagement and support. The primary health and implementation outcomes will be salivary cotinine-validated 7-day point-prevalence abstinence rate, and the adoption of two recommended measures (promoting utilization of smoking cessation treatment and implementing smoke-free workplaces) 6 months after the initial session, respectively. Other outcomes for implementation (e.g., penetration of smoking cessation clinic visits), health (e.g., salivary cotinine-validated 7-day point-prevalence abstinence rate at 12 months), and process (e.g., adherence and potential moderating factors) will be collected via questionnaires, interviews, logbooks, and interventionists’ notes at 6 and 12 months. An economic analysis will be undertaken to assess the cost-effectiveness of the implementation interventions at 12 months.DiscussionThis will be the first cluster randomized controlled trial to evaluate the effectiveness of an implementation intervention with interactive assistance for employers and health managers in SMEs on smoking cessation and implementation of evidence-based tobacco control measures in SMEs. The findings of this trial targeting management in SMEs have the potential to accelerate the implementation of evidence-based smoking cessation methods as well as abstinence rates among employees in SMEs across Japan.Trial registrationThe study protocol has been registered in the UMIN Clinical Trials Registry (UMIN-CTR; ID: UMIN000044526). Registered on 06/14/2021.

Utilization and Effectiveness of a Message-Based Tobacco Cessation Program (mCessation) in the Chinese General Population: Longitudinal, Real-world Study.

Randomized controlled trials on text message interventions for smoking cessation have shown they are effective and recommended for tobacco control. However, the effectiveness in real-world settings is largely unknown, especially in low- and middle-income countries. This study aimed to provide real-world evidence about the utilization and effectiveness of a message-based tobacco cessation program (mCessation) in China. From May 2021 to September 2022, 16,746 people from the general population participated in the mCessation program provided by the World Health Organization. All participants received text messages on smoking cessation via instant messaging for 6 months, and they were also required to report smoking status. We randomly selected 2500 participants and interviewed them by telephone to determine the 7-day point prevalence abstinence rate at 6 months. Descriptive statistics were used to analyze population characteristics and abstinence rate. Logistic regression analysis was performed to explore risk factors for the abstinence rate. Among the 2500 participants, the mean age was 35 years, and most (2407/2500, 96.20%) were male. The prevalence of tobacco dependence and light degree of tobacco dependence were 85.70% (2142/2500) and 89.10% (2228/2500), respectively. For respondents (953/2500, 38.10%), the 7-day point prevalence abstinence rate at 6 months was 21.90% (209/953). Participants older than 40 years or with tobacco dependence had significantly higher abstinence rates than those who were younger than 30 years old (odds ratio [OR] 1.77, 95% CI 1.06-3.29) or without dependence (OR 1.64, 95% CI 1.08-2.51), respectively. However, married people or heavily dependent smokers tended to find it more difficult to successfully quit smoking compared with unmarried people (OR 0.57, 95% CI 0.34-0.93) or lightly dependent smokers (OR 0.16, 95% CI 0.02-0.98), respectively. In a real-world setting, mCessation China was generally acceptable to men and lightly dependent smokers, and it could help 1 in 5 smokers aged 18 years to 67 years quit smoking. However, strategies to increase awareness of young and married adults may improve implementation and abstinence rates.

Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)—a structured summary of a study protocol for a randomized controlled study

BackgroundCigarette smoking is the leading preventable cause of premature death. Despite dedicated programmes, quit rates remain low due to barriers such as nicotine withdrawal syndrome or post-cessation weight gain. Glucagon-like peptide-1 (GLP-1) analogues reduce energy intake and body weight and seem to modulate addictive behaviour. These GLP-1 properties are of major interest in the context of smoking cessation. The aim of this study is to evaluate the GLP-1 analogue dulaglutide as a new therapy for smoking cessation.MethodsThis is a placebo-controlled, double-blind, parallel group, superiority, single-centre randomized study including 255 patients. The intervention consists of a 12-week dulaglutide treatment phase with 1.5 mg once weekly or placebo subcutaneously, in addition to standard of care (behavioural counselling and pharmacotherapy with varenicline). A 40-week non-treatment phase follows. The primary outcome is the point prevalence abstinence rate at week 12. Smoking status is self-reported and biochemically confirmed by end-expiratory exhaled carbon monoxide measurement. Further endpoints include post-cessational weight gain, nicotine craving analysis, glucose homeostasis and long-term nicotine abstinence.Two separate substudies assess behavioural, functional and structural changes by functional magnetic resonance imaging and measures of energy metabolism (i.e. resting energy expenditure, body composition).DiscussionCombining behavioural counselling and medical therapy, e.g. with varenicline, improves abstinence rates and is considered the standard of care. We expect a further increase in quit rates by adding a second component of medical therapy and assume a dual effect of dulaglutide treatment (blunting nicotine withdrawal symptoms and reducing post-cessational weight gain). This project is of high relevance as it explores novel treatment options aimed at preventing the disastrous consequences of nicotine consumption and obesity.Trial registrationClinicalTrials.gov NCT03204396. Registered on June 26, 2017.

The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis.

Smoking is a leading cause of premature death globally. Quitting smoking reduces the risk of all-cause mortality by 11%-34%. Smartphone app-based smoking cessation (SASC) interventions have been developed and are widely used. However, the evidence for the effectiveness of smartphone-based interventions for smoking cessation is currently equivocal. The purpose of this study was to synthesize the evidence for the effectiveness of smartphone app-based interventions for smoking cessation. We conducted a systematic review and meta-analysis of the effectiveness of smartphone interventions for smoking cessation based on the Cochrane methodology. An electronic literature search was performed using the Cochrane Library, Web of Science, PubMed, Embase, PsycINFO, China National Knowledge Infrastructure, and Wanfang databases to identify published papers in English or Chinese (there was no time limit regarding the publication date). The outcome was the smoking abstinence rate, which was either a 7-day point prevalence abstinence rate or a continuous abstinence rate. A total of 9 randomized controlled trials involving 12,967 adults were selected for the final analysis. The selected studies from 6 countries (the United States, Spain, France, Switzerland, Canada, and Japan) were included in the meta-analysis between 2018 and 2022. Pooled effect sizes (across all follow-up time points) revealed no difference between the smartphone app group and the comparators (standard care, SMS text messaging intervention, web-based intervention, smoking cessation counseling, or apps as placebos without real function; odds ratio [OR] 1.25, 95% CI 0.99-1.56, P=.06, I2=73.6%). Based on the subanalyses, 6 trials comparing smartphone app interventions to comparator interventions reported no significant differences in effectiveness (OR 1.03, 95% CI 0.85-1.26, P=.74, I2=57.1%). However, the 3 trials that evaluated the combination of smartphone interventions combined with pharmacotherapy compared to pharmacotherapy alone found higher smoking abstinence rates in the combined intervention (OR 1.79, 95% CI 1.38-2.33, P=.74, I2=7.4%). All SASC interventions with higher levels of adherence were significantly more effective (OR 1.48, 95% CI 1.20-1.84, P<.001, I2=24.5%). This systematic review and meta-analysis did not support the effectiveness of delivering smartphone-based interventions alone to achieve higher smoking abstinence rates. However, the efficacy of smartphone-based interventions increased when combined with pharmacotherapy-based smoking cessation approaches. PROSPERO CRD42021267615; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=267615.

Effect of dulaglutide in promoting abstinence during smokingcessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial.

Quitting smoking is difficult due to barriers such as craving for cigarettes and post-cessation weight gain. Recent experimental data suggest a role of glucagon-like peptide-1 (GLP-1) in the pathophysiology of addiction in addition to appetite regulation and weight control. We hypothesized that a pharmacological intervention with the GLP-1 analogue dulaglutide during smoking cessation may improve abstinence rates and reduce post-cessation weight gain. This is a single-centre, randomized, double-blind, placebo-controlled, parallel group, superiority study conducted in the University Hospital Basel in Switzerland. We included adult smokers with at least moderate cigarette dependence who wanted to quit. Participants were randomly assigned to a 12-week treatment with dulaglutide 1.5mg once weekly or placebo subcutaneously in addition to standard of care including behavioural counselling and oral varenicline pharmacotherapy of 2mg/day. The primary outcome was self-reported and biochemically confirmed point prevalence abstinence rate at week 12. Secondary outcomes included post-cessation weight, glucose metabolism, and craving for smoking. All participants who received one dose of study drug were included in the primary and safety analyses. The trial was registered on ClinicalTrials.gov (NCT03204396). Between June 22, 2017, and December 3, 2020, 255 participants were enrolled and randomly assigned to each group (127 in the dulaglutide group and 128 in the placebo group). After 12 weeks, 63% (80/127) participants on dulaglutide and 65% (83/128) on placebo treatment were abstinent (difference in proportions-1.9% [95% Confidence interval (CI)-10.7, 14.4], p-value (p)=0.859). Dulaglutide decreased post-cessation weight (-1kg [standard deviation (SD) 2.7]), while weight increased on placebo (+1.9kg [SD 2.4]). The baseline-adjusted difference in weight change between groups was-2.9kg (95% CI -3.59,-2.3, p<0.001). Haemoglobin A1c (HbA1c) level declined on dulaglutide treatment (baseline-adjusted median difference in HbA1c between groups-0.25% [interquartile range (IQR) -0.36,-0.14], p<0.001). Craving for smoking declined during treatment without any difference between the groups. Treatment-emergent gastrointestinal symptoms were very common in both groups: 90% (114/127) of participants on dulaglutide and 81% (81/128) on placebo). Dulaglutide had no effect on abstinence rates but prevented post-cessation weight gain and decreased HbA1c levels. GLP-1 analogues may play a role in future cessation therapy targeting metabolic parameters such as weight and glucose metabolism. Swiss National Science Foundation, the Gottfried Julia Bangerter-Rhyner Foundation, the Goldschmidt-Jacobson Foundation, the Hemmi-Foundation, the University of Basel, the Swiss Academy of Medical Sciences.

Efficacy of Combined Relaxed Deep-Breathing with Chest Mobilization Exercise and Vernonia cinerea-Hard Candy on Smoking Cessation and Oxidative Stress in Active Teenage Smokers

Background: Smoking cessation is very important worldwide. Chronic smoking can induce oxidative stress and inflammatory status and induce dangerous diseases such as hypertension and lung cancer. Standardized counseling is an important process in a routine program for smoking cessation. Withdrawal symptoms from smoking cessation are a significant barrier to a successful result, and they can be relieved by relaxed deep-breathing exercise. At present, the Thai herb, Vernonia cinerea (VC), has been claimed to reduce cigarette smoking because of its antioxidant compounds and nicotine that are modified and used as lozenges, gum, and hard candy. However, its efficacy in smoking cessation has not been confirmed. Furthermore, the efficacy of relaxed deep-breathing (rDB) during the chest mobilization exercise (CME) with VC hard candy on smoking cessation and oxidative stress is unclear. Objective: This study aimed to evaluate the combined effects of rDB/CME and VC-hard candy on smoking cessation and oxidative stress status in active teenage smokers. Methods: Hard candy with honey and VC powder from whole mixed parts of the stem, flowers and leaves was developed industrially under the spray dry technique. Thirty active smokers were randomized into three groups; product group (rDB/CME+ product) (aged 25.0 ± 3.0 years, n = 10), placebo group (rDB/CME + placebo) (aged 26.9 ± 3.7 years, n = 10), and a control group with no product or placebo administered (aged 25.6 ± 2.7 years, n=10). All of the groups received consultation on specific smoking cessation and two weeks of strict observation, which was followed up for 8 weeks. The 7-day point prevalence abstinence rates (7-day PAR) and continuous abstinence rate (CAR) were reported at week 2, 4, 6 and 8. In addition, the oxidative stress status with lipid peroxide and glutathione (GSH) in blood was evaluated before the program and after 2 weeks. Results: The results of 7-day PARs in the control group showed no statistical changes at week 2 (0%), 4 (10%), 6 (20%) and 8 (20%), which was the same in the rDB/CME + placebo group (10%, 20%, 30% and 40%, respectively). Whereas, a significant difference was presented in the rDB/CME+ product group (20%, 60%, 80% and 90% respectively). When comparing between the groups, 7-day PARs at week 2 was not statistically different, but it was in the follow-up period at week 4, 6 and 8. There was no statistical difference at week 4 between the three groups, but there was between the rDB/CME+ product, control and rDB/CME+ placebo groups at week 6 and 8. The results of CAR showed no statistical difference between the control and rDB/CWE+ placebo group in any of the periods. Whereas the rDB/CWE+ product group showed a significant difference after week 4. The CAR was statistically different between the groups after week 6 and 8. At week 6, the CAR of the rDB/CWE+ product group was different to the control group. There was no difference between the control and rDB/CWE+ placebo groups, or between the rDB/CWE+ product and placebo groups. At week 8, the CAR of the rDB/CWE+ product group was different from that of the control, but not from the rDB/CWE+ placebo group. Finally, the GSH level increased significantly in the rDB/CWE + product group when compared to the rDB/CWE+placebo group. Moreover, malondialdehyde (MDA) levels decreased significantly in both the placebo and product groups. In addition, MDA levels showed a significant difference between baseline and after 2 weeks in the rDB/CWE + placebo and product groups. Conclusion: Integrating relaxed-deep breathing with chest mobilization exercise and VC hard candy for 2 weeks can help smoking cessation during consultation, and possibly reduce oxidative stress status among active teenage smokers.

Cytisinicline for Smoking Cessation in Adult Smokers

Cytisinicline is a naturally derived, plant-based medication that has been developed as a treatment for smoking cessation and nicotine dependence. Based on a product available in Europe, over 4 million smokers in Central and Eastern Europe have used this medication and over 10,000 subjects have participated in clinical trials worldwide. Cytisinicline acts as a partial agonist and partial antagonist for the alpha-4 beta-2 nicotinic acetylcholine receptors in the brain, which are the same receptors that are activated by nicotine. Cytisinicline helps to reduce cravings, withdrawal symptoms and the reward and satisfaction associated with smoking by preventing nicotine from binding to these receptors and releasing dopamine. The On-going Research of Cytisinicline for Addiction-1 clinical trial has shown that participants receiving 3.0 mg cytisinicline three times daily had the highest biochemically verified point-prevalence abstinence rate (50%) compared with placebo (10%) at the end of treatment, with no significant safety concerns. These quit results were statistically significant (p&lt;0.001). Cytisinicline demonstrates weak binding to the 5-hydroxytryptamine 3 receptor that causes nausea, consistent with few observed nausea events in participants receiving cytisinicline. No new medications for tobacco dependence have received United States Food and Drug Administration approval since 2006. Cytisinicline represents a promising treatment for those globally who continue to smoke tobacco.

Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial

BackgroundWith advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts.MethodsThe current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers.DiscussionThis study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings.Trial Registration ClinicalTrials.gov: NCT05019495 (August 24, 2021).

RF32 | PSUN59 Glucagon-Like Peptide-1 Analogues: A New Way to Quit Smoking? SKIP – a Randomised Controlled Study

Abstract Background Cigarette smoking is the leading preventable cause of premature death. Despite dedicated programs, quit rates remain low due to barriers such as nicotine withdrawal syndrome or post-cessation weight gain. Glucagon-like peptide-1 (GLP-1) analogues reduce energy intake and body weight and seem to modulate addictive behavior. These GLP-1 properties are of major interest in the context of smoking cessation. The aim of this study was to evaluate the GLP-1 analogue dulaglutide as a new therapy for smoking cessation. Methods This was a placebo-controlled, double-blind, parallel group, superiority, single-center randomized study including 255 patients. The intervention consisted of a 12-week treatment phase with dulaglutide 1.5 mg or placebo injected subcutaneously at a weekly study visit, in addition to standard of care (behavioral counselling and pharmacotherapy with varenicline). Point-prevalence abstinence rate at week 12 as primary outcome was assessed by self-reported smoking status and biochemical confirmation by end-expiratory exhaled carbon monoxide measurement. We further investigated weight gain and changes in the glucose homeostasis at week 12. In a substudy (n=71), we compared behavioral (i.e., nicotine craving measured by a Visual Analogue Scale from 1-7) and brain activity changes in response to smoking cue videos using functional magnetic resonance imaging (fMRI) at baseline and week 12. Results The point-prevalence abstinence rate after 12 weeks of treatment was 80/127 (63%) in the dulaglutide group and 82/128 (65%) in the placebo group (difference in proportions [95% CI] -1.9% [-10.7, 14.4], p=0.859). We observed an increase in weight in the placebo (+1.8kg [SD 2.4]) and a decrease in the dulaglutide group (-0.7kg [SD 3.3]) between baseline and week 12; baseline-adjusted difference in weight change [95% CI] -2.5kg [-3.3, -1.7], p&amp;lt;0.001. Craving in response to smoking cue videos decreased from baseline to week 12 (estimated mean difference [95% CI] -3.0 [-3.7, -2.3], p&amp;lt;0.001), with no difference between dulaglutide and placebo (estimated mean difference [95% CI] 0.4 [-1.2, 2.0], p=0.6). Similarly, no difference in whole brain functional activity was seen between the two treatments, at both time points and between baseline and follow up. Conclusion In this study, an exceptional high point prevalence abstinence rate in both groups was observed, most probably due to the very close (weekly) supervision of the patients. Our data provides no evidence that dulaglutide modulates nicotine craving or smoking cessation rates. Nevertheless, GLP-1 analogues such as dulaglutide may be a promising treatment during smoking cessation as it may avoid post-cessation weight gain. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 1:24 p.m. - 1:29 p.m.

Evaluating smoking cessation service at an emergency department clinical observation unit.

To evaluate the effectiveness of a pilot smoking cessation service in an emergency department (ED) clinical observation unit. A descriptive case series review was undertaken of smoking cessation service patients in the short-stay unit of an acute hospital in Singapore from July 1, 2018, to December 31, 2019. Upon admission, ED nurses screen all patients regarding their current smoking status and implement the 5 A's framework, which involves the steps of Ask-Advise-Assess-Assist-Arrange. Patients in the "contemplation" and "preparation" stages were offered the following components: (1) a bedside counseling session by a pharmacist and (2) a follow-up appointment at an outpatient smoking cessation clinic. Postdischarge follow-up telephone calls at 1, 6, and 12 months were carried out as part of the study data collection to obtain abstinence information. Forty-seven patients were included in the study; the majority were male (n = 41; 87.2%). The median numbers of cigarettes smoked per day at baseline, 1 month, 6 months, and 12 months were 14, 5, 3, and 5, respectively. The overall point-prevalence abstinence rates over the same follow-up time points were 26.5%, 38.7%, and 31.3%, respectively. The proportions of patients lost to follow-up at 1 month, 6 months, and 12 months were 27.7%, 34.0%, and 31.9%, respectively. Given the small sample and high number of uncontactable patients, more research is needed to assess whether the trend toward increasing point-prevalence abstinence rate over time and the trend toward decreasing median number of cigarettes smoked are observed in a larger sample.