Standard Smoking Cessation Research Articles

Evaluating the Effects of a Brief Tobacco Intervention in the US Air Force.

Military personnel have among the highest rates of tobacco use in the United States. Unfortunately, there are few interventions aimed at reducing tobacco use among this vulnerable population. The current study addresses this need by evaluating the short-term effectiveness of a Brief Tobacco Intervention (BTI), a 40-min group-based intervention designed to reduce contemporary patterns of tobacco use among a sample of US military enlistees during an 11-week period of involuntary tobacco abstinence. Participants were 2999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018. Participants were cluster randomized to three conditions: (1) BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention. The primary analysis was a comparison of the interventions' efficacies in preventing tobacco use during Technical Training, conducted using a generalized estimating equations logistic regression model controlling for covariates. Multiple imputation was used to account for loss to follow-up. There was not a significant difference by condition in the use of tobacco products at follow-up (p = .454). The BTI + AG condition did produce short-term changes in perceived harm, intentions to use tobacco, knowledge about tobacco products, and normative beliefs. These findings suggest that while the intervention was effective in the short term, it was not potent enough over a 12-week period to prevent Airmen from initiating tobacco use. Future studies should examine whether adding a booster session or media campaign enhances the effectiveness of the intervention. Despite the fact that most Airmen believe they will remain tobacco free following the ban in Technical Training, a large percentage of these Airmen resume and initiate tobacco use during this high-risk period. As a result, there is a need for interventions targeting the range of tobacco available to military trainees during a teachable moment when they report intentions to remain tobacco free. The current study shows that a BTI has promise in reducing long-term tobacco use, when coupled with additional interventions, such as a booster session or a media campaign.

The effectiveness of smartphone applications to aid smoking cessation: A meta-analysis

IntroductionSmartphone smoking cessation applications (SCAs) are widely available and extensively used by smokers to aid smoking cessation. However, their efficacy is unproven. The aim of this meta-analysis was to determine the effect of SCAs with or without standard smoking cessation interventions (usual care) on quit rates amongst adult smokers in comparison to control apps and/or usual care. MethodsA comprehensive review of the literature conducted in January 2019 identified randomised controlled trials (RCTs) and non-RCTs published in English which investigated SCAs to aid smoking cessation in adults. Two authors screened 293 studies, of which 8 studies were included. The data for analysing smoking abstinence and risk of bias was extracted independently by two authors. Meta-analysis was conducted using the mixed-effects method in the RevMan software to calculate pooled risk ratios (RRs) with 95% confidence intervals. ResultsAcross 8 studies with 3,543 participants there was no statistically significant improvement in the rate of abstinence at 2 to 6 months compared to usual care (RR 1.15, 95% CI 0.85 to 1.57). There was moderate heterogeneity (with I2 of 57%) between the included studies. DiscussionAt present, there is insufficient evidence to routinely recommend SCAs for smoking cessation in usual care. However, further study is required to evaluate the effectiveness of SCAs as their low cost, wide availability and absence of side effects may make them useful adjuncts in some populations. Future RCTs could enrol participants using a more conventional approach applying methods published in trials evaluating medical adjuncts for smoking cessation. The studies included in this analysis demonstrate significant heterogeneity which may have reduced the capacity of the analysis to demonstrate significance.

Advances in biofeedback and neurofeedback studies on smoking

Smoking is a leading cause of morbidity and premature death constituting a global health challenge. Although, pharmacological and behavioral approaches comprise the mainstay of smoking cessation interventions, the efficacy and safety of pharmacotherapy is not demonstrated for some populations. Non-pharmacological approaches, such as biofeedback (BF) and neurofeedback (NF) could facilitate self-regulation of predisposing factors of relapse such as craving and stress. The current review aims to aggregate the existing evidence regarding the effects of BF and NF training on smokers. Relevant studies were identified through searching in Scopus, PubMed and Cochrane Library, and through hand-searching the references of screened articles. Peer-reviewed controlled and uncontrolled studies, where BF and/or NF training was administered, were included and evaluated according to PICOS framework. Narrative qualitative synthesis of ten eligible studies was performed, aggregated into three categories according to training provided. BF outcomes seem to be affected by smoking behavior prior to training; individualized EEG NF training holds promise for modulating craving-related response while minimizing the required number of sessions. Real-time fMRI NF studies concluded that nicotine-dependent individuals could modulate craving-related brain responses, while mixed results were revealed regarding smokers’ ability to modulate brain responses related to resistance towards the urge to smoke. BF and NF training seem to facilitate modulation of autonomous and/or central nervous system activity while also transferring this learned self-regulation to behavioral outcomes. BF and NF training should a) address remaining issues on specificity and scientific validity, b) target diverse demographics, and c) produce robust reproducible methodologies and clinical guidelines for relevant health care providers, in order to be considered as viable complementary tools to standard smoking cessation care.

Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: Japanese study protocol

BackgroundDespite a steady world-wide decline over recent decades, rates of smoking remain high in developed countries. In Japan, 30% of men and 10% of women are smokers. Based on these rates, 18.8 million (14.06 million men and 4.74 million women) in Japan are smokers. The rate of success for smoking cessation has recently improved due to the widespread availability of drug therapy; however, the success rate for quitting smoking one year after beginning therapy is only around 50%. Previous studies have demonstrated that exercise can relieve mental stress during continuous abstinence from smoking and curb smoking resumption. To date, no large-scale, randomized controlled trials have examined the effects of exercise on smoking cessation. The present study aims to determine the effects of exercise instruction on continuous abstinence from smoking after completion of smoking cessation therapy.MethodsThis is a multicenter, prospective, parallel-group, randomized controlled trial in Japan. We will enroll 300 individuals visiting a smoking cessation clinic (over 3 months) who have abstained from smoking in the second month after their initial visit as potential participants. Participants will not habitually exercise and will need to consent to participate. Participants will be randomly assigned to the exercise intervention group or control group. The intervention group will receive instruction on exercises that can be incorporated into their daily lives. The control group will be followed during the standard smoking cessation support program. The primary endpoint will be the continuous abstinence rate, and secondary endpoints will be weight, blood pressure, exhaled carbon monoxide concentration, psychological state, and blood test results. These indices will be compared between the intervention and control groups, with follow-up periods of 9 months in both groups.DiscussionBy examining the effects of exercise instruction after completion of 12-week smoking cessation therapy, this study should yield quality information that can be used to develop protocols to improve the continuous abstinence rate and inhibit weight gain after smoking cessation therapy.Trial registrationUMIN Clinical Trials Registry, UMIN000014615. Registered on 1 October 2014.

A Randomised Controlled Trial of a Novel Digital Therapy for Smoking Cessation

Background: Evidence-based digital therapies for smoking cessation that include a smartphone application (app), the efficacy of which is scientifically demonstrated, are limited. The present study sought to demonstrate the efficacy of a novel digital therapy, 'CureApp Smoking Cessation' (CASC), integrated with a mobile carbon monoxide (CO) checker. Methods: In this multi-centre randomised controlled trial (RCT), 584 participants with nicotine dependence were allocated 1:1 to CASC intervention or control groups by a computer-generated random sequence with stratification for smoking cessation medications and study sites. Both groups received a standard smoking cessation treatment with pharmacotherapy and counselling for 12 weeks. The intervention group used the CASC system, and the control group used a control-app without a mobile CO checker, both for 24 weeks. The primary outcome was the biochemically validated continuous abstinence rate (CAR) from weeks 9-24. Main secondary outcome was an extended CAR from weeks 9-52. Findings: Except for 12 participants who did not download or use the apps, 285 participants were assigned to the intervention group, and 287, to the control group. CAR from weeks 9-24 in the intervention group was significantly higher than that in the control group (63·9% vs 50·5%; odds ratio [OR], 1·73; 95% confidence interval [CI], 1·24 to 2·42; p=0·001). CAR from weeks 9-52 also was higher in the intervention group than that in the control group (52·3% vs 41·5%; OR, 1·64; 95% CI, 1·16 to 2·32; p=0·005). No specific adverse events caused by the CASC system were reported. Interpretation: Despite the restricted areas and ages in Japan, in which smartphone usage rates were high, this study was the first large RCT with a smartphone-based digital therapy for smoking cessation with a long-term observation period. Augmenting the standard treatment with pharmacotherapy, the digital therapy, the CASC system, significantly improved long-term CARs. Funding Statement: CureApp, Inc. Declaration of Interests: KM, HT, and KF have received honoraria from CureApp, Inc. AN received consulting fees from CureApp, Inc. AN and KS are founders of the CureApp Institute. TM is an employee of CureApp, Inc. KS and SS are founders and shareholders of CureApp, Inc. and patent holders of the CASC. EH has a consultation contract as a biostatistician with CureApp, Inc. Ethics Approval Statement: The study was performed in compliance with CONSORT statements. The protocol and informed consent forms were reviewed and approved by the Institutional Review Board at Keio University School of Medicine and all affiliated institutions.

A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics

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

Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial.

Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation. To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation. Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy. At 6months post-hospitalization, persistent smokers were re-engaged with either CCC or C. Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12months post-discharge. Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6months (55.2%) and between 6 and 12months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6-12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)). Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications. NCT01063972.

Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized Controlled Trial.

BackgroundSmoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear.ObjectiveThe aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence.MethodsThis study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events.ResultsWe will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019.ConclusionsThis will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975International Registered Report Identifier (IRRID)DERR1-10.2196/12701

Standard smoking cessation services in sites participating in the SCIMITAR+ trial for people with severe mental ill health.

Aims and methodThe SCIMITAR+ trial was commissioned to evaluate the effectiveness of a bespoke smoking cessation intervention for people with severe mental ill health compared with usual services. It is difficult to define what constitutes usual care in smoking cessation services. We aimed to define what this was during the trial. Twenty-two National Health Service healthcare providers participated in a bespoke survey asking about usual care in their area. RESULTS: All sites offered smoking cessation support; however, service provider and service type varied substantially. In some cases services were not streamlined, meaning that people received smoking cessation counselling from one organisation and smoking cessation medication from another.Clinical implicationsTo better implement the National Institute for Health and Care Excellence guideline PH48, clearer referral pathways need to be implemented and communicated to patients, staff and carers. People with severe mental ill health need to be able to access services that combine nicotine replacement therapy and behavioural support in a streamlined manner.Declaration of interestNone.

Cost-Effectiveness of a Specialist Smoking Cessation Package Compared with Standard Smoking Cessation Service for People with Severe Mental Illness in England: A Trial-Based Economic Evaluation From the SCIMITAR+ Study

Background: The declining smoking prevalence in the general population is not reflected among people with severe mental illness (SMI) who smoke. Clinically and cost-effective strategies specific to this population are needed. Methods: A pragmatic two-arm parallel group individually randomised controlled trial was carried out to compare an SMI bespoke smoking cessation (BSC) intervention with usual care (UC). Eligible participants were adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses from 16 primary care and 21 secondary care mental health sites in England, UK. Simple randomisation was used following a computer-generated random number sequence masking the allocation but it was not concealed post-randomisation. Total costs, including smoking cessation cost, healthcare and social services costs, and quality-adjusted life years (QALYs), derived from EQ-5D-5L, were used to calculate incremental cost-effectiveness ratio at 12 months post-randomisation. Findings: Between October 2015 and December 2016, 261 participants were randomised to UC group, and 265 to BSC group. After adjustment, the mean total costs in BSC group were £270 (95% CI -£1,690 to £1,424) lower than in UC group while the mean QALYs were 0.026 (95% CI -0·008 to 0·045) higher, leading to BSC dominating UC (95% CI -£339,590 to £295,805 per QALY gained). Interpretation: The cost of BSC did not increase overall costs, indicating a positive effect in health, but a longer time horizon is needed to conclude the impact of quitting on costs and health related gains. Trial Registration: The trial registration number is ISRCTN72955454. Funding Statement: National Institute for Health Research Health Technology Assessment Programme (11/136/52). Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: Ethical approval was granted by NRES Committee Yorkshire & The Humber-Leeds East REC (19/03/2015, ref: 15/YH/0051).

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis

BackgroundSmoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy.A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called ‘MiQuit’ to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit’s evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy.Methods/designThis is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks’ gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks’ gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate.DiscussionIf effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking.Trial registrationClinicalTrials.gov, ID: NCT03231553. Registered on 20 July 2017.

Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial.

BackgroundTobacco is a major public health concern. A 12-week standard smoking cessation program is available in Japan; however, it requires face-to-face clinic visits, which has been one of the key obstacles to completing the program, leading to a low smoking cessation success rate. Telemedicine using internet-based video counseling instead of regular clinic visits could address this obstacle.ObjectiveThis study aimed to evaluate the efficacy and feasibility of an internet-based remote smoking cessation support program compared with the standard face-to-face clinical visit program among patients with nicotine dependence.MethodsThis study was a randomized, controlled, open-label, multicenter, noninferiority trial. We recruited nicotine-dependent adults from March to June 2018. Participants randomized to the telemedicine arm received internet-based video counseling, whereas control participants received standard face-to-face clinic visits at each time point in the smoking cessation program. Both arms received a CureApp Smoking Cessation smartphone app with a mobile exhaled carbon monoxide checker. The primary outcome was a continuous abstinence rate (CAR) from weeks 9 to 12. Full analysis set was used for data analysis.ResultsWe randomized 115 participants with nicotine dependence: 58 were allocated to the telemedicine (internet-based video counseling) arm and 57, to the control (standard face-to-face clinical visit) arm. We analyzed all 115 participants for the primary outcome. Both telemedicine and control groups had similar CARs from weeks 9 to 12 (81.0% vs 78.9%; absolute difference, 2.1%; 95% CI –12.8 to 17.0), and the lower limit of the difference between groups (–12.8%) was greater than the prespecified limit (–15%).ConclusionsThe application of telemedicine using internet-based video counseling as a smoking cessation program had a similar CAR from weeks 9 to 12 as that of the standard face-to-face clinical visit program. The efficacy of the telemedicine-based smoking cessation program was not inferior to that of the standard visit–based smoking cessation program.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975.

Approach bias retraining to augment smoking cessation: Study protocol for a randomized controlled trial.

Heavy users and addicted individuals have shown to develop an approach action tendency – or approach bias – toward stimuli related to the substance of interest. Emerging evidence points to approach bias retraining (ABR) as an effective aid for the treatment of addictive behaviors. The current study seeks to extend this work by testing, in a pilot study, whether standard smoking cessation treatment involving cognitive-behavioral therapy (CBT) and nicotine replacement therapy can be augmented by ABR. To this end, we will randomly assign 100 adult smokers to either ABR-augmented treatment or placebo-augmented treatment and compare the two conditions on short-term and long-term abstinence rates. The hope is that the findings of this study can inform treatment development for adult smokers.

Impact of a Novel Smartphone App (CureApp Smoking Cessation) on Nicotine Dependence: Prospective Single-Arm Interventional Pilot Study.

BackgroundMobile apps have been considered to provide active and continuous support for smoking cessation. However, it is yet to be known whether a smoking cessation smartphone app improves long-term abstinence rates in nicotine-dependent patients.ObjectiveThis study aimed to evaluate the long-term abstinence effect of a novel smartphone app, CureApp Smoking Cessation (CASC), in patients with nicotine dependence.MethodsIn this prospective, interventional, multicenter, single-arm study, we provided the CASC app to all the participants, who used it daily for 24 weeks. The CASC app includes features to maximize the therapeutic effect of pharmacological therapies and counseling at outpatient clinics for smoking cessation. The primary endpoint was a continuous abstinence rate (CAR) from weeks 9 to 24, whereas secondary endpoints were CARs from weeks 9 to 12 and 9 to 52.ResultsOf the 56 adult smokers recruited, 1 did not download the app; therefore, 55 participants constituted the full analysis sample. The CAR from weeks 9 to 24 was 64% (35/55, 95% CI 51%-76%), whereas the CARs from weeks 9 to 12 and 9 to 52 were 76% (42/55, 95% CI 65%-88%) and 58% (32/55, 95% CI 46%-71%), respectively. These CARs were better than the results of the national survey on outpatient clinics with regard to smoking cessation under the National Health Insurance Program and that of the varenicline phase 3 trial in Japan and the United States. There was only 1 participant who dropped out during the 12 weeks of the treatment period. This treatment decreased the scores related to withdrawal and craving symptoms.ConclusionsThe addition of CASC to usual smoking cessation therapies resulted in high CARs, high patient retention rates, and improvement of cessation-related symptoms. The smartphone app CASC is a feasible and useful tool to help long-term continuous abstinence that can be combined with a standard smoking cessation treatment program.

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial.

BackgroundSmoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment.ObjectiveThis study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs.MethodsThis will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52.ResultsWe will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc.ConclusionsThis is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry UMIN000031589; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033555International Registered Report Identifier (IRRID)DERR1-10.2196/12252

The Effectiveness of Smartphone Applications to Aid Smoking Cessation: A Meta-Analysis

Importance: Smartphone smoking cessation applications are extensively used by smokers to aid smoking cessation, are cost effective and widely available. Despite these benefits, their effectiveness remains inconclusive.Objective: To determine the effect of smoking cessation applications with or without standard smoking cessation interventions (usual care) on quit rates amongst adult smokers in comparison to control apps and/or usual care.Data sources: We searched Ovid Medline, CINAHL, Embase, AustHealth and the Cochrane Library on the 18th and 19th June 2018, updated on 22nd January 2019 supplemented by hand searching reference lists from relevant papers. Search terms for article retrieval included m-health, mhealth, smartphone, phone app, mobile app, mobile applications, quit smoking, smoking prevention, tobacco cessation, smoking cessation, smoking cessation programs, smoking, tobacco use cessation. The search was restricted to papers published in English, clinical trials, meta-analysis, randomised controlled trials and systematic review reviews.Study selection: We included randomised controlled trials and non-randomised controlled trials which enrolled currently smoking adults who wanted to quit smoking and reported smoking abstinence. We included studies that tested a dedicated smoking cessation application. Title and abstracts were screened by two authors independently using Covidence software. Disagreements were resolved by discussion with a third author.Data extraction and synthesis: Of 293 unique articles, 8 studies with a total of 3,543 participants met inclusion criteria. Risk ratio was calculated in RevMan using the default DerSimonian and Laird random effects model after Mantel-Haenszel fixed effects estimation.Main outcome measure: Smoking abstinence rates.Results: There was no statistically significant change in the rate of abstinence with smartphone smoking cessation applications, compared to usual care (RR 1.15, 95% CI 0.85 to 1.57). There was moderate heterogeneity (I2 57%) between studies.Conclusions and relevance: At present, there is insufficient evidence to routinely recommend smoking cessation applications for smoking cessation, however further research is warranted given the significant heterogeneity of the included studies which may have reduced the positive effects demonstrated in some studies.Funding: Self-funded by the authors.Declaration of Interest: As per the ICMJE Form for Disclosure of Potential Conflicts of Interest, the authors of this manuscript have no conflicts of interest.Ethical Approval: As this was a meta-analysis no ethical approval was required or was obtained.

Increasing Home Smoking Restrictions Boosts Underserved Moms' Bioverified Quit Success.

Objectives: Standard smoking cessation treatments remain relatively ineffective in vulnerable populations. This study tested whether efforts to restrict residential smoking mediated the counseling treatment - smoking cessation association in a child tobacco smoke exposure (TSE) reduction trial. Methods: Maternal smokers (N = 300) with young children from low-income minority communities were randomized to counseling or standard care control to promote child TSE reduction. Secondary mediation analyses controlled for factors associated with smoking cessation. Results: Counseling group mothers were more likely than controls to increase home smoking restrictions (OR = 1.9, 95% CI 1.1-3.4) and quit smoking (OR = 11.0, 95% CI 6.3-19.2). As hypothesized, increasing home smoking restrictions improved likelihood of bioverified quit status at end of treatment (OR = 2.5, 95% CI 1.1-5.9) and partially mediated the association between counseling intervention and quit status. Conclusions: Results suggest that among maternal smokers known to experience increased challenges to quitting smoking, encouraging efforts to protect children from TSE by increasing home smoking restrictions may be an important counseling intervention element that facilitates smoking cessation.

YMCA exercise intervention to augment smoking cessation treatment in adults with high anxiety sensitivity: Study protocol for a randomized controlled trial

Extant evidence suggests that exercise can reduce anxiety related vulnerability factors, such as anxiety sensitivity (AS), or fear of bodily sensations related to anxiety, that negatively impact smoking cessation outcomes. Building upon emerging evidence supporting the efficacy of exercise as an aid for smoking cessation in adults with high AS, we are conducting a trial to examine the efficacy and feasibility of this clinical application when implemented in a community setting. Partnering with the YMCA, this study aims to enroll 150 adults in a standard smoking cessation protocol (i.e. counseling and nicotine replacement therapy) and randomly assign them to either 15 weeks of programmed vigorous-intensity or low-intensity exercise. Smoking abstinence data will be collected up to 6 months following the quit attempt.

Mediators of the effect of nicotine pre-treatment on quitting smoking.

Using smoking cessation medications for several weeks prior to quitting smoking facilitates quitting success, but how it does so is not clear. Candidate theories are that pre-cessation medication enhances self-efficacy, facilitates medication adherence post-quit, induces aversion to smoking, reduces reward from smoking or reduces the drive to smoke. We investigated these pathways using data from a large trial of nicotine pre-loading, using mediation analysis. Randomized controlled trial of nicotine pre-loading. Potential mediators were assessed at baseline and 1week into the pre-loading (3weeks prior to quitting). In addition to this, urges to smoke in abstainers were assessed 1week after the target quit date. England. A total of 1792 smokers who wanted to quit attending specialist smoking cessation services in England were enrolled between 13 August 2012 and 10 March 2015. Participants were randomized to either standard smoking cessation medications accompanied by behavioural support or the same treatment supplemented by nicotine 'pre-loading', i.e. 4weeks of 21mg nicotine patch use prior to quitting. The primary outcome, selected for its proximity in time to potential mediators, was biochemically validated abstinence from smoking at 4weeks post-target quit date. Potential mediators included the Modified Cigarette Evaluation Questionnaire, with subscales assessing satisfaction, reward, craving and aversion; ratings of strength and frequency of urges to smoke; the Mood and Physical Symptoms Scale assessing cigarette withdrawal symptoms; two items from the Nicotine Dependence Syndrome Scale assessing smoking stereotypy; self-reported reduction in cigarettes per day and in carbon monoxide (CO) reading; post-target quit day (TQD) medication adherence; self-efficacy; nausea. Pre-loading reduced urges to smoke at 3weeks pre-quit (P<0.001) and exhaled CO concentrations (P<0.001), and also urges to smoke post-quit in abstainers (P=0.001). At 3weeks pre-quit, it also reduced cigarette consumption, enjoyment of and satisfaction from smoking and smoking reward and increased nausea, aversion (all P<0.001) and smoking stereotypy (P=0.003). Only the first three variables, however (reduced smoke intake and reduced urges to smoke pre- and post-quit), mediated abstinence from smoking at 4weeks and only the latter two mediated abstinence at 6months (indirect mediating effects P<0.05). Nicotine pre-loading appears to facilitate smoking abstinence by reducing urges to smoke and smoke intake before quitting and urges to smoke after quitting.

Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease

Smokers with chronic obstructive pulmonary disease (COPD) have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might offer a strategy for reducing harm from cigarettes and provide a pathway for later cessation. To compare the effect of LT-NRT vs standard smoking cessation (SSC) on exposure to cigarette smoke, harm related to smoking, and cessation among smokers with COPD. This unblinded, randomized clinical trial recruited smokers who self-reported a diagnosis of COPD at any level of readiness to quit from May 23, 2014, through November 30, 2015. The 12-month follow-up was completed December 6, 2016. Patients were recruited at a clinical research unit of an academic medical center. Analysis was based on intention to treat and performed from March 8 through November 30, 2017. Standard smoking cessation treatment included 10 weeks of NRT and 4 follow-up counseling sessions for those willing to make a quit attempt. Long-term NRT included 12 months of NRT and 6 follow-up counseling sessions regardless of initial willingness to quit. Overall, 198 patients were randomized to SSC, and 197 were included in the primary analysis; 200 patients were randomized to LT-NRT, and 197 were included in the primary analysis. The primary outcome was 7-day abstinence verified by carbon monoxide (CO) levels at 12 months. Secondary outcomes included cigarettes smoked per day (CPD), exposure to CO, urinary excretion of 4-methylnitrosamino-1-3-pyridyl-1-butanol (NNAL) (a smoking-related carcinogen), and adverse events. Among 398 patients who were randomized (59.8% female; mean [SD] age, 56.0 [9.3] years), the mean (SD) CPD was 23.1 (12.3). Twelve-month follow-up was completed by 373 participants (93.7%), and 394 (99.0%) were included in the primary analysis. At 12 months, CO-verified abstinence occurred in 23 of 197 participants (11.7%) in the SSC arm and 24 of 197 (12.2%) in the LT-NRT arm (risk difference, 0.5%; 95% CI, -5.9% to 6.9%). Continuing smokers in the SSC and LT-NRT arms had similar, significantly reduced harms caused by smoking, including cigarette consumption by 12.4 and 14.5 CPD, respectively, exhaled CO level by 5.5 and 7.8 ppm, respectively, and mean urinary NNAL excretion by 21.7% and 23.0%, respectively. In multivariate analyses, continuing smokers with greater adherence to NRT experienced less reduction in NNAL exposure. The frequency of major adverse cardiac events was similar in both groups. Similar rates of cessation and similar reductions in exposure to tobacco smoke resulted with LT-NRT and SSC. Among continuing smokers, ongoing use of NRT was not associated with reductions in smoke exposure. ClinicalTrials.gov Identifier: NCT02148445.