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Background Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e‐liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update conducted as part of a living systematic review. Objectives To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long‐term smoking abstinence. Search methods We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 May 2021, and reference‐checked and contacted study authors. We screened abstracts from the Society for Research on Nicotine and Tobacco (SRNT) 2021 Annual Meeting. Selection criteria We included randomized controlled trials (RCTs) and randomized cross‐over trials, in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report abstinence from cigarettes at six months or longer or data on safety markers at one week or longer, or both. Data collection and analysis We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow‐up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included the proportion of people still using study product (EC or pharmacotherapy) at six or more months after randomization or starting EC use, changes in carbon monoxide (CO), blood pressure (BP), heart rate, arterial oxygen saturation, lung function, and levels of carcinogens or toxicants or both. We used a fixed‐effect Mantel‐Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in meta‐analyses. Main results We included 61 completed studies, representing 16,759 participants, of which 34 were RCTs. Five of the 61 included studies were new to this review update. Of the included studies, we rated seven (all contributing to our main comparisons) at low risk of bias overall, 42 at high risk overall (including all non‐randomized studies), and the remainder at unclear risk. There was moderate‐certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.53, 95% confidence interval (CI) 1.21 to 1.93; I2 = 0%; 4 studies, 1924 participants). In absolute terms, this might translate to an additional three quitters per 100 (95% CI 1 to 6). There was low‐certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.44, 95% CI 0.94 to 2.19: I2 = 0; 3 studies, 1183 participants). There was moderate‐certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non‐nicotine EC (RR 1.94, 95% CI 1.21 to 3.13; I2 = 0%; 5 studies, 1447 participants). In absolute terms, this might lead to an additional seven quitters per 100 (95% CI 2 to 16). There was moderate‐certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.95, 95% CI 0.52 to 1.72; I2 = 0; 6 studies, 1033 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.61, 95% CI 1.44 to 4.74; I2 = 0%; 6 studies, 2886 participants). In absolute terms this represents an additional six quitters per 100 (95% CI 2 to 15). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was some evidence that non‐serious AEs were more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants), and again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 1.51, 95% CI 0.70 to 3.24; I2 = 0%; 7 studies, 1303 participants). Data from non‐randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons, hence evidence for these is limited, with CIs often encompassing clinically significant harm and benefit. Authors' conclusions There is moderate‐certainty evidence that ECs with nicotine increase quit rates compared to NRT and compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the effect size. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non‐nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect evidence of harm from nicotine EC, but longest follow‐up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates, but further RCTs are underway. To ensure the review continues to provide up‐to‐date information to decision‐makers, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.

BACKGROUND AND AIMS The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e-cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. DESIGN Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6-month follow-up. SETTING Stop smoking service in London, UK. PARTICIPANTS A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. INTERVENTIONS Participants received either NRT of their choice (8-week supply) or an EC starter pack and instructions to purchase further e-liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. MEASUREMENTS Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6-month follow-up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop-outs were included as 'non-reducers'. FINDINGS Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6-12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5-27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P

Introduction Varenicline and combination nicotine replacement treatment (cNRT) have been recommended as the most effective pharmacotherapies, with equal abstinence rate for smoking cessation in a network meta-analysis of randomized trials, but data from real-world long-term follow-up studies are rare. This study aimed to compare the 12-month sustained abstinence rates of smokers using varenicline versus cNRT in their quit attempt. Methods A total of 3569 smokers were recruited via the Department of Family Medicine outpatient department at Kaohsiung Veteran General Hospital between June 2013 and March 2019. Participants received counseling from a physician and chose either varenicline (N = 2870) or cNRT (N = 699) for smoking cessation. Both varenicline and cNRT users could receive a free 8-week supply and eight clinic visits over 90 days. Participants were followed-up by telephone at 12, 24, and 52 weeks from first visit. The primary outcome measure of the study was self-reported sustained abstinence up to 52 weeks. Results Varenicline users had a significantly higher sustained abstinence rate at weeks 12–52, adjusted for baseline variables (15.2% vs 10.3%, p = .001; adjusted odds ratio = 1.47, 95% confidence interval: 1.05–2.05). Other significant predictors of 52 weeks sustained abstinence were being male, having a higher income, attending more clinical visits, and have lower nicotine dependence. Conclusion Varenicline appears to have higher sustained abstinence rates to 52 weeks compared with cNRT, in a smoking cessation clinic where smokers can choose their medication option. Implications Network meta-analysis of randomized trials suggests that varenicline and cNRT are similarly effective for smoking cessation. This study shows that 1-year sustained abstinence rates were significantly higher among smokers using varenicline, compared with smokers using cNRT, when used as part of a structured smoking cessation program. These findings are highly relevant to policy makers and service providers to help determine provision of smoking cessation treatment.

Background Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic ‘emergency’ use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions. Design A randomised controlled trial. Setting English stop smoking services and Australian quitlines, Australian social media and St Vincent’s Hospital Melbourne, Fitzroy, VIC. Participants Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited. Interventions Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages (n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages (n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages (n = 58) or (4) usual care plus static text messages (n = 59). Outcome measures Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete. Results The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively (p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively (p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings. Limitations The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention. Conclusions Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution. Future work Further studies of both interventions are warranted, using simpler study designs. Trial registration Current Controlled Trials ISRCTN11111428. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.

This study assessed the effectiveness of a 3.5-h training session for general practitioners (GPs) in providing brief stop-smoking advice and compared two methods of giving advice – ABC versus 5As – on the rates of delivery of such advice and of recommendations of evidence-based smoking cessation treatment during routine consultations. A pragmatic, two-arm cluster randomised controlled trial was carried out including a pre-/post-design for the analyses of the primary outcome in 52 GP practices in Germany. Practices were randomised (1:1) to receive a 3.5-h training session (ABC or 5As). In total, 1937 tobacco-smoking patients, who consulted trained GPs in these practices in the 6 weeks prior to or following the training, were included. The primary outcome was patient-reported rates of GP-delivered stop-smoking advice prior to and following the training, irrespective of the training method. Secondary outcomes were patient-reported receipt of recommendation/prescription of behavioural therapy, pharmacotherapy or combination therapy for smoking cessation, and the effectiveness of ABC versus 5As regarding all outcomes. GP-delivered stop-smoking advice increased from 13.1% (n=136 out of 1039) to 33.1% (n=297 out of 898) following the training (adjusted odds ratio (aOR) 3.25, 95% CI 2.34–4.51). Recommendation/prescription rates of evidence-based treatments were low (, A brief, single training session is effective in changing GP behaviour for providing stop-smoking advice and evidence-based cessation treatment. Training according to the very brief ABC method may lead to higher rates of such GP-delivered advice. https://bit.ly/2TciPSO

Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95–2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

Aim To evaluate the cost-effectiveness of e-cigarettes as a smoking cessation aid used in routine stop smoking service. Design Cost-effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12 months period and lifetime. Costs, including that of both treatments, other smoking cessation help and healthcare services, and health benefits, estimated from EQ-5D-5L and measured in Quality-adjusted Life years (QALYs), for the 12-month analysis came from a randomised controlled trial. Lifetime analysis was model-based with input from both trial data and published secondary data sources. Cost-effectiveness was measured by an incremental cost-effectiveness ratio (ICER). Setting Three English Stop-Smoking Service sites in England Participants Adult smokers who sought help to quit in the participating sites Intervention and comparator An e-cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to three months, both with standard behavioural support. A total of 886 participants were randomised (439 in EC arm, 447 in NRT arm). Excluding one death in each arm, the one-year quit rate was 18.0% and 9.9%, respectively. Measurements Cost of treatments was estimated from treatment log. Costs of other smoking cessation help and healthcare services, and EQ-5D-5L were collected at baseline, six- and 12-month follow-ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values. Findings The ICER was £1,100 per QALY gained at the 12 months after quit date (87% - 90% probability of cost-effective between £20,000/QALY and £30,000/QALY). Markov model estimated the lifetime ICER of EC to be £65 per QALY (around 85% probability of cost-effective between £20,000/QALY and £30,000/QALY). Conclusion Using e-cigarette as a smoking cessation aid with standard behavioural support in an English Stop-Smoking Service is more cost-effective than using nicotine replacement therapy in the same setting.

Importance Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions Treatments were provided in accordance with the manufacturers’ recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, −1.62% [1-sided 97.5% CI, −5.02% to ∞];P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95;P = .002). Conclusions and Relevance Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration anzctr.org.au Identifier:ACTRN12616001654448

ObjectivesPeople suffering from mental health disorder (MHDs) are often under-represented in clinical research though the reasons for their exclusion are rarely recorded. As they have higher rates of smoking and nicotine dependence, it is crucial that they are adequately represented in clinical trials of established pharmacotherapy interventions for smoking cessation. This review aims to examine the practice of excluding smokers with MHDs and reasons for such exclusion in clinical trials evaluating pharmacotherapy treatments for smoking cessation.Data sourceThe Cochrane database of systematic reviews was searched until September 2020 for reviews on smoking cessation using pharmacotherapies.Study selectionRandomised controlled trials (RCTs) within the selected Cochrane reviews were included.Data extractionConducted by one author and independently verified by three authors.Data synthesisWe included 279 RCTs from 13 Cochrane reviews. Of all studies, 51 (18.3%) explicitly excluded participants with any MHDs, 152 (54.5%) conditionally excluded based on certain MHD criteria and 76 (27.2%) provided insufficient information to ascertain either inclusion or exclusion. Studies of antidepressant medications used for smoking cessation were found to be 3.33 times more likely (95% CI 1.38 to 8.01, p=0.007) to conditionally exclude smokers with MHDs than explicitly exclude compared with studies of nicotine replacement therapy.ConclusionSmokers with MHDs are not sufficiently represented in RCTs examining the safety and effectiveness of smoking cessation medications. Greater access to clinical trial participation needs to be facilitated for this group to better address access to appropriate pharmacotherapeutic interventions in this vulnerable population.

This narrative review provides a summary of the impact of tobacco smoking on the respiratory system and the benefits of smoking cessation. Tobacco smoking is one of the leading preventable causes of death world-wide and a major risk factor for lung cancer and chronic obstructive pulmonary disease. Smoking is also associated with an increased risk of respiratory infections and appears to be related to poorer outcomes among those with COVID-19. Non-smokers with second-hand smoke exposure also experience significant adverse respiratory effects. Smoking imposes enormous health- and non-health-related costs to societies. The benefits of smoking cessation, in both prevention and management of respiratory disease, have been known for decades and, to this day, cessation support remains one of the most important cost-effective interventions that health professionals can provide to people who smoke. Cessation at any age confers substantial health benefits, even in smokers with established morbidities. As other treatments for chronic respiratory disease advance and survival rates increase, smoking cessation treatment will become even more relevant. While smoking cessation interventions are available, the offer of these by clinicians and uptake by patients remain limited.

OBJECTIVE To estimate prevalence of vaping in pregnancy. Compare characteristics and attitudes between exclusive smokers and vapers, and between exclusive vapers and dual users (smoke and vape). DESIGN Cross-sectional survey. SETTING Hospitals across England and Scotland. POPULATION Pregnant women attending antenatal clinics in 2017. METHODS Women at 8-24 weeks' gestation completed screening questions about their smoking and vaping. Current or recent ex-smokers and/or vapers completed a full detailed survey about vaping and smoking. MAIN OUTCOME MEASURES The prevalence of vaping, characteristics and attitudes of women who vape and/or smoke. RESULTS Of 3360 pregnant women who completed screening questions, 515 (15.3%, 95% CI 14.1-16.6) were exclusive smokers, 44 (1.3%, 95% CI 1.0-1.8) exclusive vapers and 118 (3.5%, 95% CI 2.9-4.2) dual users. In total, 867 (25.8%) women completed the full survey; compared with smokers (n = 434), vapers (n = 140) were more likely to hold higher educational qualifications (odds ratio [OR) 1.51, 95% CI 1.01-2.25). Compared with exclusive vapers (n = 33), dual users (n = 107) were younger (OR 0.91 95% CI 0.85-0.98) and less likely to hold high qualifications (OR 0.43, 95% CI 0.20-0.96). Compared with smokers, dual users were more likely to be planning to quit smoking (OR 2.27, 95% CI 1.24-4.18). Compared with smokers, vapers were more likely to think vaping was safer than smoking (78.6% versus 36.4%). CONCLUSIONS One in 20 pregnant women report vaping, and most also smoke. Dual users are more motivated towards stopping smoking than smokers. Where women have tried but cannot stop smoking, clinicians could encourage them to consider vaping for smoking cessation. TWEETABLE EXTRACT One in 20 women report vaping during pregnancy but of those that do vape, most also smoke, despite having intentions to quit.

To examine factors associated with Quitline and pharmacotherapy utilisation in low socioeconomic status (low-SES) smokers enrolled in a smoking cessation trial.Baseline data was used from a large-scale smoking cessation randomised controlled trial (RCT). Logistic regression models were used to examine predictors of treatment utilisation prior to entering the RCT and perceived effectiveness of past and future use.A total of 1047 smokers consented and prior to enrolment 92% had previously tried to quit smoking, 86% had ever used quit support, 83% had used pharmacotherapy at least once and 38% had ever utilised Quitline. For those who had used pharmacotherapies, 71% used NRT, of which 21% had used dual NRT products. In the last 12-months, 27% utilised Quitline and 50% utilised NRT. Ever use of Quitline was negatively associated with self-efficacy to quit (OR: 0.80; 95% CI: 0.68, 0.94 p .01) and positively associated with being diagnosed with a mental health condition (OR: 1.50; 95% CI: 1.01, 2.25 p .05). Recent use of NRT was positively associated with mental health condition (OR: 1.39; 95% CI: 1.02, 1.90 p .05) and negatively associated with alcohol consumption (OR: 0.69; 95% CI: 0.52, 0.92 p .01).Past use of Quitline and pharmacotherapy treatment was associated with self-efficacy to quit, sociodemographic variables, mental health conditions and alcohol consumption. Community-based strategies that target smoking, mental health and drug and alcohol problems may overcome some of the barriers that prevent low-SES populations from engaging with smoking cessation support.

OBJECTIVETo assess the effectiveness of a 3.5h-training for general practitioners (GPs) in two different methods (ABC, 5As) of giving brief stop-smoking advice during routine consultations.DESIGNPragmatic two-arm cluster randomised controlled trial with pre-post-design for the primary outcome and cluster randomisation for secondary outcomes.SETTINGGeneral practices, North Rhine-Westphalia (German federal state), recruited 2017-2019.PARTICIPANTSPractices were randomised (1:1) to an ABC or 5As training. Tobacco smoking, adult patients, who consulted trained GPs in these practices in the 6 weeks prior to or following the training were eligible to participate. Ineligible were: non-smokers, patients who did not meet the GP in person, or could not provide informed consent.INTERVENTIONSTwo different standardised 3.5h-trainings (ABC or 5As) for GPs in delivering brief stop-smoking advice were carried out per study cycle (six cycles in total). Trainings were moderated by a senior researcher and an experienced GP, and included role-plays with professional actors.MAIN OUTCOME MEASURESPrimary outcome: patient-reported rates of GP-delivered stop-smoking advice prior and following the training, irrespective of the training method. Secondary outcomes: patient-reported receipt of recommendation/prescription of evidence-based smoking cessation treatment: including behavioural support, any pharmacotherapy (nicotine replacement therapy (NRT), varenicline, or bupropion), or a combination therapy; and the effectiveness of ABC versus 5As regarding all outcomes.RANDOMISATION AND MASKINGComputer-generated block randomisation or, if not feasible, randomisation based on the GPs’ temporal availability at training dates. GPs were not fully blinded. Patients were blinded to the nature of the study until data collection ended.RESULTS52 GP practices (27 ABC, 25 5As) with 69 GPs were included. Of 5,406 patients who provided informed consent, 1,937 (35.9%) were current smokers, of whom 1,039 were interviewed prior to and 898 following the training. GP-delivered stop-smoking advice increased from 13.1% (n=136/1,039) to 33.1% (n=297/898) following the training (adjusted odds ratio (aOR)=3.25, 95%CI=2.34 to 4.51). Recommendation/prescription rates of treatment were low (CONCLUSIONSIn GPs in Germany, a single session of training in stop-smoking advice was associated with a three-fold increase in rates of advice giving and a seven-fold increase in offer of support. The ABC method may lead to higher rates of GP-delivered stop-smoking advice during routine consultations. Approaches to further increase the delivery of such advice, and upscaling implementation strategies for the training in general practice, should be evaluated.TRIAL REGISTRATIONGerman Clinical Trials Register: DRKS00012786.WHAT IS ALREADY KNOWN ON THIS TOPICThe implementation of clinical guideline recommendations stating that general practitioners (GPs) should routinely deliver brief stop-smoking advice and offer evidence-based smoking cessation treatment is low in Germany, a country with a smoking prevalence of ∼28%.A strategy is needed to overcome barriers (e.g., lack in knowledge and skills) preventing GPs from routinely delivering stop-smoking advice. No experimental study has evaluated such a strategy in German general practice so far.Two different methods of delivering such advice are recommended in the national guidelines – ABC and 5As – but it is unclear which method can be more effectively implemented by trained GPs.WHAT THIS STUDY ADDSThis cluster randomised controlled trial evaluated the effectiveness of a 3.5h-training for GPs in delivering brief stop-smoking advice and compared two different methods (ABC vs. 5As) regarding the rates of delivery of such advice and recommendations of evidence-based cessation treatment in 1,937 smoking patients from 52 GP practices in Germany.The training, irrespective of the method, was associated with a three-fold increase in rates of advice giving and a seven-fold increase in the offer of support.The data indicate that training according to ABC may be more effective than 5As in increasing the rates of GP-delivered stop-smoking advice.

Context: Use of electronic cigarettes (ECs) is on the rise in most high-income countries. Smoking conventional cigarettes is a known risk factor for urologic malignancy incidence, progression, and mortality, as well as for other urologic health indicators. The potential impact of EC use on urologic health is therefore of clinical interest to the urology community. Objective: To review the available data on current EC use, including potential benefits in urologic patients, potential issues linked to toxicology of EC constituents, and how this might translate into urologic health risks. Evidence acquisition: A Medline search was carried out in August 2016 for studies reporting urologic health outcomes and EC use. Snowballing techniques were also used to identify relevant studies from recent systematic reviews. A narrative synthesis of data around EC health outcomes, toxicology, and potential use in smoking cessation and health policy was carried out. Evidence synthesis: We found no studies to date that have been specifically designed to prospectively assess urologic health risks, even in an observational setting. Generating such data would be an important contribution to the debate on the role of ECs in public health and clinical practice. There is evidence from a recent Cochrane review of RCTs that ECs can support smoking cessation. There are emerging data indicating that potentially harmful components of ECs such as tobacco-specific nitrosamines, polyaromatic hydrocarbons, and heavy metals could be linked to possible urologic health risks. Conclusions: ECs might be a useful tool to encourage cessation of conventional cigarette smoking. However, data collection around the specific impact of ECs on urologic health is needed to clarify the possible patient benefits, outcomes, and adverse events. Patient summary: While electronic cigarettes might help some people to stop smoking, their overall impact on urologic health is not clear. While electronic cigarettes might help some people to stop smoking, it is not clear if they may be bad for urologic health.

Introduction Little is known about effects of smoking cessation on alcohol consumption. Varenicline reduces enjoyment of smoking and cigarette consumption and may also reduce enjoyment and consumption of alcohol. We conducted the first prospective examination of the effects of stopping smoking on alcohol enjoyment and consumption and compared clients using varenicline and nicotine replacement treatment (NRT). Methods Audit of records from clients undergoing routine smoking cessation treatment in three stop-smoking services in London, United Kingdom. The sample comprised smokers who consume alcohol and underwent smoking cessation treatment with either varenicline (N = 230) or NRT (N = 62). Alcohol enjoyment and consumption were reported before and on the target quit day (TQD) and 1 and 4 weeks post-TQD. Results Participants reduced their alcohol consumption in week 1 of their quit attempt (15.0-12.7 units per/week, p = .001).In heavy drinkers, the change remained significant at 4 weeks (32.2-24.8 units per/week, p = .004). The type of medication used had no significant impact on the change. Smokers treated with varenicline versus NRT were more likely to report reduced enjoyment of alcohol on TQD (20% vs. 10%, respectively, p < .001) and at 4 weeks post-TQD (20% vs. 6%, respectively, p = .014). Results were similar for abstainers and those who did not manage to stop smoking. Conclusion Making a stop-smoking attempt is accompanied by a reduction in drinking. The finding has implications for policies concerned with effects of stopping smoking on alcohol use. Varenicline may affect enjoyment of drinking, but its potential to alter drinking behavior is small. Implications The finding that smokers making a quit attempt reduce their alcohol consumption has practical implications for treatment providers who are concerned about the possible effects of smoking cessation on alcohol drinking. Although varenicline may reduce alcohol enjoyment compared to NRT, it does not appear to have a significant impact on alcohol consumption.

The use of electronic cigarettes (EC) is increasing and the number of EC publications is rapidly growing. While some health organizations focus on the harmful effects of using EC (vaping), others promote the benefits of ECs as a less harmful alternative to smoking tobacco. There is concern that vaping might have adverse respiratory consequences for pediatric patients facing anesthesia and intensive care. This narrative review summarizes current knowledge and recommendations regarding the risks of EC relevant to the anesthesiologist and the use of ECs as a step-down option from tobacco. We provide guidance on the management of vaping patients in the perioperative period.

Background Mobile phone-based smoking cessation support (mCessation) offers the opportunity to provide behavioural support to those who cannot or do not want face-to-face support. In addition, mCessation can be automated and therefore provided affordably even in resource-poor settings. This is an update of a Cochrane Review first published in 2006, and previously updated in 2009 and 2012. Objectives To determine whether mobile phone-based smoking cessation interventions increase smoking cessation rates in people who smoke. Search methods For this update, we searched the Cochrane Tobacco Addiction Group's Specialised Register, along with clinicaltrials.gov and the ICTRP. The date of the most recent searches was 29 October 2018. Selection criteria Participants were smokers of any age. Eligible interventions were those testing any type of predominantly mobile phone-based programme (such as text messages (or smartphone app) for smoking cessation. We included randomised controlled trials with smoking cessation outcomes reported at at least six-month follow-up. Data collection and analysis We used standard methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We performed both study eligibility checks and data extraction in duplicate. We performed meta-analyses of the most stringent measures of abstinence at six months' follow-up or longer, using a Mantel-Haenszel random-effects method, pooling studies with similar interventions and similar comparators to calculate risk ratios (RR) and their corresponding 95% confidence intervals (CI). We conducted analyses including all randomised (with dropouts counted as still smoking) and complete cases only. Main results This review includes 26 studies (33,849 participants). Overall, we judged 13 studies to be at low risk of bias, three at high risk, and the remainder at unclear risk. Settings and recruitment procedures varied across studies, but most studies were conducted in high-income countries. There was moderate-certainty evidence, limited by inconsistency, that automated text messaging interventions were more effective than minimal smoking cessation support (RR 1.54, 95% CI 1.19 to 2.00; I2 = 71%; 13 studies, 14,133 participants). There was also moderate-certainty evidence, limited by imprecision, that text messaging added to other smoking cessation interventions was more effective than the other smoking cessation interventions alone (RR 1.59, 95% CI 1.09 to 2.33; I2 = 0%, 4 studies, 997 participants). Two studies comparing text messaging with other smoking cessation interventions, and three studies comparing high- and low-intensity messaging, did not show significant differences between groups (RR 0.92 95% CI 0.61 to 1.40; I2 = 27%; 2 studies, 2238 participants; and RR 1.00, 95% CI 0.95 to 1.06; I2 = 0%, 3 studies, 12,985 participants, respectively) but confidence intervals were wide in the former comparison. Five studies compared a smoking cessation smartphone app with lower-intensity smoking cessation support (either a lower-intensity app or non-app minimal support). We pooled the evidence and deemed it to be of very low certainty due to inconsistency and serious imprecision. It provided no evidence that smartphone apps improved the likelihood of smoking cessation (RR 1.00, 95% CI 0.66 to 1.52; I2 = 59%; 5 studies, 3079 participants). Other smartphone apps tested differed from the apps included in the analysis, as two used contingency management and one combined text messaging with an app, and so we did not pool them. Using complete case data as opposed to using data from all participants randomised did not substantially alter the findings. Authors' conclusions There is moderate-certainty evidence that automated text message-based smoking cessation interventions result in greater quit rates than minimal smoking cessation support. There is moderate-certainty evidence of the benefit of text messaging interventions in addition to other smoking cessation support in comparison with that smoking cessation support alone. The evidence comparing smartphone apps with less intensive support was of very low certainty, and more randomised controlled trials are needed to test these interventions.

BackgroundOver the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.ObjectiveThe objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.DesignA randomised controlled trial comparing e-cigarettes and NRT.SettingThree sites that provide local SSSs.ParticipantsThe participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.InterventionsThe NRT arm (n = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm (n = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.Main outcome measuresThe primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.ResultsThe 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58;p 2 = 161.4;p LimitationsThe results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.ConclusionsWithin the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.Future workThe efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.Trial registrationCurrent Controlled Trials ISRCTN60477608.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).

Background The German clinical guideline on tobacco addiction recommends that general practitioners (GPs) provide brief stop-smoking advice to their patients according to the “5A” or the much briefer “ABC” method, but its implementation is insufficient. A lack of training is one barrier for GPs to provide such advice. Moreover, the respective effectiveness of a 5A or ABC training regarding subsequent delivery of stop-smoking advice has not been investigated. We developed a training for GPs according to both methods, and conducted a pilot study with process evaluation to optimize the trainings according to the needs of GPs. This study aims at evaluating the effectiveness of both trainings. Methods A pragmatic 2-arm cluster randomised controlled trial with a pre-post data collection will be conducted in 48 GP practices in North Rhine-Westphalia (Germany). GPs will be randomised to receive a 3.5-h-training in delivering either 5A or ABC, including peer coaching and intensive role plays with professional actors. The patient-reported primary outcome (receipt of GP advice to quit: yes/no) and secondary outcomes (recommendation rates of smoking cessation treatments, group comparison (5A versus ABC): receipt of GP advice to quit) will be collected in smoking patients routinely consulting their GP within 4 weeks prior, and 4 weeks following the training. Additional secondary outcomes will be collected at 4, 12 and 26 weeks following the consultation: use of cessation treatments during the last quit attempt (if so) since the GP consultation, and point-prevalence abstinence rates. The primary data analysis will be conducted using a mixed-effects logistic regression model with random effects for the cluster variable. Discussion If the training increases the rates of delivery of stop-smoking advice, it would offer a low-threshold strategy for the guideline implementation in German primary care. Should one method prove superior, a more specific guideline recommendation can be proposed. Trial registration German Clinical Trials Register (DRKS00012786); registered on 22th August 2017, prior to the first patient in. Open-Access-Publikationsfonds 2019

Background: Hypnotherapy is widely promoted as a method for aiding smoking cessation. It is intended to act on underlying impulses to weaken the desire to smoke, or strengthen the will to stop. Objectives: To evaluate the effect and safety of hypnotherapy for smoking cessation. Search Methods: For this update we searched the Cochrane Tobacco Addiction Group Specialized Register, and trial registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform), using the terms "smoking cessation" and "hypnotherapy" or "hypnosis", with no restrictions on language or publication date. The most recent search was performed on 18 July 2018. Selection Criteria: We considered randomized controlled trials that recruited people who smoked and implemented a hypnotherapy intervention for smoking cessation compared with no treatment, or with any other therapeutic interventions. Trials were required to report smoking cessation rates at least six months after the beginning of treatment. Study eligibility was determined by at least two review authors, independently. Data Collection and Analysis: At least two review authors independently extracted data on participant characteristics, the type and duration of hypnotherapy, the nature of the control group, smoking status, method of randomization, and completeness of follow‐up. These authors also independently assessed the quality of the included studies. In undertaking this work, we used standard methodological procedures expected by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow‐up. We used the most rigorous definition of abstinence in each trial, and biochemically validated abstinence rates where available. Those lost to follow‐up were considered to still be smoking. We summarized effects as risk ratios (RRs) and 95% confidence intervals (CIs). Where possible, we performed meta‐analysis using a fixed‐effect model. We also noted any adverse events reported. Main Results: We included three new trials in this update, which brings the total to 14 included studies that compared hypnotherapy with 22 different control interventions. The studies included a total of 1926 participants. Studies were diverse and a single meta‐analysis was not possible. We judged only one study to be at low risk of bias overall; we judged 10 studies to be at high risk of bias and three at unclear risk. Studies did not provide reliable evidence of a greater benefit from hypnotherapy compared with other interventions or no treatment for smoking cessation. Most individual studies did not find statistically significant differences in quit rates after six months or longer, and studies that did detect differences typically had methodological limitations. Pooling small groups of relatively comparable studies did not provide reliable evidence for a specific effect of hypnotherapy relative to controls. There was low certainty evidence, limited by imprecision and risk of bias, that showed no statistically significant difference between hypnotherapy and attention‐matched behavioural treatments (RR 1.21, 95% CI 0.91 to 1.61; I2 = 36%; 6 studies, 957 participants). Results were similarly imprecise, and also limited by risk of bias, when comparing hypnotherapy to intensive behavioural interventions (not matched for contact time) (RR 0.93, 95% CI 0.47 to 1.82; I2 = 0%; 2 studies, 211 participants; very low certainty evidence). Results from one small study (40 participants) detected a statistically significant benefit of hypnotherapy compared to no intervention (RR 19.00, 95% CI 1.18 to 305.88), but this evidence was judged to be of very low certainty due to high risk of bias and imprecision. No significant differences were detected in comparisons of hypnotherapy with brief behavioural interventions (RR 0.98, 95% CI 0.57 to 1.69; I² = 0%; 2 studies, 269 participants), rapid/focused smoking (RR 1.00, 95% CI 0.43 to 2.33; I2 = 65%; 2 studies, 54 participants), and pharmacotherapies (RR 1.68, 95% CI 0.88 to 3.20; I2 = 5%; 2 studies, 197 participants). When hypnotherapy was evaluated as an adjunct to other treatments, the pooled result from five studies showed a statistically significant benefit in favour of hypnotherapy (RR 2.10, 95% CI 1.31 to 3.35; I² = 62%; 224 participants); however, this result should be interpreted with caution due to the high risk of bias across studies (four had a high risk or bias, one had an unclear risk), and substantial statistical heterogeneity. Most studies did not provide information on whether data specifically relating to adverse events were collected, and whether or not any adverse events occurred. One study that did collect such data did not find a statistically significant difference in the adverse event ‘index’ between hypnotherapy and relaxation. Authors' Conclusions: There is insufficient evidence to determine whether hypnotherapy is more effective for smoking cessation than other forms of behavioural support or unassisted quitting. If a benefit is present, current evidence suggests the benefit is small at most. There is very little evidence on whether hypnotherapy causes adverse effects, but the existing data show no evidence that it does. Further large, high‐quality randomized controlled trials, and more comprehensive assessments of safety, are needed on this topic.

We are grateful for the opportunity to reply to the commentary on our Cochrane review of electronic cigarettes (EC) for smoking cessation [1] posed by Pisinger and Vestbo [2] with subsequent commentary by McAlinden et al. [3]. Footnotes This manuscript has recently been accepted for publication in the European Respiratory Journal . It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article. Conflict of Interest: Caitlin Notley has nothing to disclose. Conflict of Interest: Ailsa Butler reports payments made to institution to fund her role on the living systematic review of e-cigarettes for smoking cessation from Cancer Research UK (CRUK). Conflict of Interest: Nicola Lindson reports that her salary is paid by the University of Oxford through a grant from the UK National Institute for Health Research (NIHR); she is co-PI on a grant to carry out a Living Systematic Cochrane Review of ‘Electronic Cigarettes for Smoking Cessation’ funded by CRUK (current); PI on a programme grant to carry out a systematic review and network meta-analysis to investigate the safety and efficacy of pharmalogical treatments and electronic cigarettes for smoking cessation funded by the NIHR (current); co-applicant on a grant to investigate youth uptake of electronic cigarettes funded by CRUK (current); co-applicant on an Infrastructure grant which funds the Cochrane Tobacco Addiction Group funded by NIHR (current); co-applicant on a grant to investigate the comparative effectiveness of behavioural smoking cessation treatments funded by NIHR (ended Jan 2021); and receives payment for teaching Cochrane Authors how to write Cochrane protocols on behalf of Cochrane UK (not for profit organisation) (current) funded by Oxford Universities NHS Foundation Trust. Conflict of Interest: Chris Bullen reports research grants paid to institution (University of Auckland) from Health Research Council of NZ; contract for smoking cessation guideline review, paid to institution from NZ Ministry of Health; Contract for smokefree plan, paid to institution from Auckland Council; contract for research, paid to institution from Pfizer; research grant paid to institution from Tencent; personal fees for consulting on new NRT product from Johnson & Johnson KK (Japan); lecture fees for Lecture at Ottawa Heart Institute Annual conference, and honoraria for Manuscript writing Simon Fraser University; is President of SRNT-Oceania (unpaid); and Tobacco expert advisory group member, Health Coalition Aotearoa (unpaid). Conflict of Interest: Annika Theodoulou has nothing to disclose. Conflict of Interest: Rachna Begh has nothing to disclose. Conflict of Interest: Hayden McRobbie reports grant payments made to institution from Health Research Council (NZ), NIHR (UK) and NHMRC (AUS), outside the submitted work; and received honoraria from Pfizer for speaking at smoking cessation educational events and an advisory board meeting in Oct 2018. Conflict of Interest: Peter Hajek reports honoraria from Pfizer for contributing to Pfizer Workshop at SRNT Conference. Conflict of Interest: Nancy Rigotti reports contract for clinical trial paid to institution from Achieve Life Sciences; personal royalties for review of e-cigarettes from UpToDate; personal consulting fee from Achieve Life Sciences. Conflict of Interest: Jamie Hartmann-Boyce reports grant funding, including to support the review which this letter refers to paid to institution from Cancer Research UK; grant funding unrelated to this work paid to institution from British Heart Foundation; grant funding, including to support the review which this letter refers to, paid to institution from NIHR.

BACKGROUND: E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments. METHODS: We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms. RESULTS: A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P

BackgroundNicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data.ObjectivesTo assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading.DesignOpen-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis.SettingNHS smoking cessation clinics.ParticipantsPeople seeking help to stop smoking.InterventionsNicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators.Main outcome measuresThe primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix®; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model.ResultsIn total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) –0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62;p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73;p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI –£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving.LimitationsThe open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified.ConclusionsUse of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication.Trial registrationCurrent Controlled Trials ISRCTN33031001.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.

ObjectivesStandard smoking cessation pharmacotherapy is recommended in the post-quit period, but may also facilitate abstinence if used prior to quitting. The objective was to examine the effectiveness and cost-effectiveness of nicotine patch worn for four weeks before a quit attempt.DesignRandomised controlled open-label trial.SettingPrimary care and smoking cessation clinics in England enrolled patients between 13/08/2012 and 10/03/2015.Participants1792 people, mainly middle-aged and of lower socioeconomic status, who were daily smokers with tobacco dependence.InterventionsParticipants were randomised 1:1, using concealed randomly permuted blocks stratified by centre, to either standard smoking cessation pharmacotherapy and behavioural support or the same treatment supplemented by four weeks of 21mg nicotine patch use prior to quitting: ‘preloading’. Main outcome measuresThe primary outcome was biochemically confirmed six-month prolonged abstinence and secondary outcomes were prolonged abstinence at four weeks and 12 months. Results899 people were allocated to the preloading arm and 893 to the control arm. Biochemically validated six-month abstinence, was achieved by 157/899 (17.5%) of the intervention arm and 129/893 (14.4%) of the control arm; difference (95% confidence interval) 3.0% (-0.4% to 6.4%), odds ratio (OR) 1.25 (0.97 to 1.62), p=0.08 in the primary analysis. There was an imbalance between arms in the frequency of use of varenicline for post-cessation medication and planned adjustment for this gave an odds ratio for the effect of pre-loading of 1.34 (1.03, 1.73), p=0.03, difference 3.8% (0.4% to 7.2%). At four weeks, the difference in prolonged abstinence unadjusted for varenicline use was OR 1.21 (1.00 to 1.48), difference 4.3% (0.0% to 8.7%), p=0.05 and adjusted for varenicline use it was OR 1.32 (1.08 to 1.62) p=0.007. At 12 months the OR was 1.28 (0.97 to 1.69), difference 2.7% (-0.4% to 5.8%), p=0.09 unadjusted for varenicline use and after adjustment was OR 1.36 (1.02 to 1.80) p=0.04. 5.9% of participants discontinued preloading because they could not tolerate it. Gastrointestinal symptoms, chiefly nausea, occurred in 4.0% (2.2 to 5.9) more people in the preloading than control arm. There were eight serious adverse events in the preloading arm and eight in the control arm, odds ratio OR of 0.99 (0.36 to 2.75). Conclusions In the primary analysis there was insufficient evidence to confidently demonstrate that nicotine preloading increases subsequent smoking abstinence. The beneficial effect appears to have been masked by a concurrent reduction in the use of varenicline in people using nicotine preloading and future studies should explore ways to mitigate this unintended effect.RegistrationCurrent Controlled Trials, ISRCTN33031001.

Background and aims Nicotine replacement therapy (NRT) may be more effective in aiding smoking cessation if higher doses of nicotine from it can be tolerated. We examined the responses to, and 4-week abstinence rates observed, when titrating the dose of transdermal nicotine patch up to 84 mg/day over 4 weeks prior to a target quit date and titrating down again over 4 weeks afterwards. Design Clinical cohort study. Setting Tobacco dependence clinic, Mar del Plata, Argentina. Participants Fifty smokers seeking help with stopping smoking. Intervention Participants started on one 21-mg/24-hour patch 4 weeks prior to their target quit day (TQD). The dose was increased weekly by adding a 21-mg patch unless participants reported adverse effects and/or did not wish to increase the dose. The dose was reduced by 21 mg/day each week from 1 week post-TQD, until it reverted to the standard dose (21 mg/day) at 4 weeks post-TQD. Participants received weekly behavioural support and could also use oral NRT from the TQD. Participants were advised to smoke ad libitum during the pre-quit period. Measurements Proportion of participants progressing through each stage of dosing, adherence, adverse effects, changes in cigarette consumption, smoke intake and enjoyment of smoking during the pre-quit period; withdrawal symptoms; carbon monoxide-validated abstinence during 4 weeks post-TQD. Findings Of the 50 participants, 72.0% (n = 36) progressed to the 84-mg nicotine dose and 94.0% (n = 47) completed the trial. Adverse effects consisted primarily of nausea and were mild and well tolerated. Cigarette consumption, smoke intake and enjoyment of smoking declined significantly during the pre-quit period. Forty-one (82%) participants achieved 4 weeks validated abstinence. Abstainers experienced no detectable cigarette withdrawal symptoms. Conclusions Most smokers seeking help with stopping appear to be able to tolerate doses of transdermal nicotine patch up to 84 mg/day during a 4-week pre-quit up-titration period with minimal side effects.

Background The social gradient in smoking rates persist with an overrepresentation of smoking and its associated harms concentrated within lower socioeconomic status (SES) populations. Low-SES smokers are motivated to quit but face multiple barriers when engaging a quit attempt. An understanding of the current treatment service model from the perspectives of treatment-seeking low-SES smokers is needed to inform the design of alternative smoking cessation support services tailored to the needs of low-SES populations. This qualitative study aimed to: i) explore low-SES smokers’ recent quitting experiences; ii) assess factors that impact treatment engagement; and iii) determine the acceptability and feasibility of alternative approaches to smoking cessation. Method Low-SES participants (n = 24) previously enrolled in a smoking cessation RCT participated in either a semi-structured focus group or in-depth telephone interview. Data was obtained and analysed using thematic analysis from October 2015 to June 2016. Analysis was deductive from the interview guide and supplemented inductively. Results Participants expressed feelings of guilt and shame around their smoking behaviour and experienced stigmatisation for their smoking. Guilt, shame, and stigmatisation negatively impacted treatment seeking behaviours with most avoiding current quit services. Costs of pharmacotherapy and treatment adherence were commonly cited barriers to treatment success. Electronic-cigarettes were perceived to be unsafe due to uncertainty on their legal status and regulatory restrictions. Technology-based text-messaging quit support was endorsed as a more favourable alternative compared to existing behavioural treatment services. Conclusion Stigmatisation was commonly endorsed and acted as an impediment to current treatment utilisation. Electronic-cigarettes may present a viable harm reduction alternative, but their likely uptake in socioeconomically disadvantaged groups in Australia is limited by smokers’ uncertainty about their regulation and legality. Mobile phone based cessation support may provide an alternative to telephone counselling and overcome the stigmatisation low-SES smokers face while trying to quit.

Aims Little is known about features of e-cigarettes (EC) that facilitate or hinder the switch from smoking to vaping. We tested eight brands of EC to determine how nicotine delivery and other product characteristics influence user’s initial reactions. Methods Fifteen vapers tested each product after overnight abstinence from both smoking and vaping. At each session, participant’s vaped ad lib for 5 min. Blood samples were taken at baseline and at 2, 4, 6, 8, 10 and 30 min after starting vaping. Participants rated the products on a range of characteristics. The products tested included six ‘cig-a-like’ and two refillable products, one with variable voltage. We also tested participants’ own EC. Results All products significantly reduced urges to smoke. Refillable products delivered more nicotine and received generally superior ratings in terms of craving relief, subjective nicotine delivery, throat hit and vapour production but in overall ratings, they were joined by a cig-a-like, Blu. Participants puffed more on low nicotine delivery products. Participants’ estimates of nicotine delivery from different EC were closely linked to ‘throat hit’. Nicotine delivery was less important in the initial product ratings than draw resistance, mouthpiece comfort and effects on reducing urge to smoke. Conclusions All EC products reduced urges to smoke. Refillable products received generally more favourable ratings than ‘cig-a-likes’ with similar nicotine content. Perception of nicotine delivery was guided by throat sensations. Lower nicotine delivery was associated with more frequent puffing. The first impressions of EC products are guided less by nicotine delivery than by sensory signals.

Introduction In the Fit2Quit randomised controlled trial, insufficiently-active adult cigarette smokers who contacted Quitline for support to quit smoking were randomised to usual Quitline support or to also receive ≤10 face-to-face and telephone exercise-support sessions delivered by trained exercise facilitators over the 24-week trial. This paper aims to determine the cost-effectiveness of an exercise-counselling intervention added to Quitline compared to Quitline alone in the Fit2Quit trial. Material and Methods Within-trial and lifetime cost-effectiveness were assessed. A published Markov model was adapted, with smokers facing increased risks of lung cancer and cardiovascular disease. Results Over 24 weeks, the incremental programme cost per participant in the intervention was NZ$428 (US$289 or €226; purchasing power parity-adjusted [PPP]). The incremental cost-effectiveness ratio (ICER) for seven-day point prevalence measured at 24-week follow-up was NZ$31,733 (US$21,432 or €16,737 PPP-adjusted) per smoker abstaining. However, for the 52% who adhered to the intervention (≥7 contacts), the ICER for point prevalence was NZ$3,991 (US$2,695 or €2,105 PPP-adjusted). In this adherent subgroup, the Markov model estimated 0.057 and 0.068 discounted quality-adjusted life-year gains over the lifetime of 40-year-old males (ICER: NZ$4,431; US$2,993 or €2,337 PPP-adjusted) and females (ICER: NZ$2,909; US$1,965 or €1,534 PPP-adjusted). Conclusions The exercise-counselling intervention will only be cost-effective if adherence is a minimum of ≥7 intervention calls, which in turn leads to a sufficient number of quitters for health gains. Trial registration Australasian Clinical Trials Registry Number ACTRN12609000637246

BackgroundPlacebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, almost doubles the chances of quitting at 6 months. We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit. MethodsWe conducted a pragmatic, open-label, noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks. Cytisine was provided by mail, free of charge, and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges. Low-intensity, telephone-delivered behavioral support was provided to both groups through the quitline. The primary outcome was self-reported continuous abstinence at 1 month. ResultsAt 1 month, continuous abstinence from smoking was repor...

Aims We reviewed available research on the use, content and safety of electronic cigarettes (EC), and on their effects on users, to assess their potential for harm or benefit and to extract evidence that can guide future policy. Methods Studies were identified by systematic database searches and screening references to February 2014. Results EC aerosol can contain some of the toxicants present in tobacco smoke, but at levels which are much lower. Long-term health effects of EC use are unknown but compared with cigarettes, EC are likely to be much less, if at all, harmful to users or bystanders. EC are increasingly popular among smokers, but to date there is no evidence of regular use by never-smokers or by non-smoking children. EC enable some users to reduce or quit smoking. Conclusions Allowing EC to compete with cigarettes in the market-place might decrease smoking-related morbidity and mortality. Regulating EC as strictly as cigarettes, or even more strictly as some regulators propose, is not warranted on current evidence. Health professionals may consider advising smokers unable or unwilling to quit through other routes to switch to EC as a safer alternative to smoking and a possible pathway to complete cessation of nicotine use.

Tobacco smoking is common among people with mental illnesses, and they carry a higher burden of smoking-related illnesses. Despite this, smoke-free policies and systems for supporting cessation have proved difficult to introduce in mental health and drug and alcohol services (MHDAS). This paper examines the barriers to becoming smoke free within New Zealand services. Key informants, including staff, smoke-free coordinators, and cessation specialists were interviewed. Of the 142 invited informants 61 agreed (42%) to participate in a telephone interview, and 56 provided useable data. Organizations had a permissive or transitioning smoking culture, or were smoke free, defined by smoke-free environments, smoke-free-promoting attitudes and behaviours of management and staff, and cessation support. Most organizations were on a continuum between permissive and transitional cultures. Only eight services had a fully smoke-free culture. MHDAS face many challenges in the transition to a smoke-free culture. They are not helped by exemptions in smoke-free policies for mental health services, staff smoking, negative staff attitudes to becoming smoke free, poor knowledge of nicotine dependence, smoking-related harm and comorbidities, and poor knowledge and skills regarding cessation-support options. Health inequalities will continue across both service and socioeconomic divides without a concerted effort to address smoking.

It is widely believed that nicotine withdrawal symptoms appear within a few hours of stopping smoking, but few data exist documenting their emergence in naturalistic settings. In several countries, nicotine replacement products are licensed for relief of withdrawal symptoms during temporary abstinence, but again, there are no data supporting this from naturalistic settings. To examine the emergence of cigarette craving and withdrawal symptoms during temporary abstinence in a naturalistic setting while using either nicotine or placebo gum. Double-blind, randomised, placebo-controlled study in which 132 dependent smokers abstained for 6 h with the assistance of either nicotine (2 mg, n = 42 or 4 mg, n = 24) or placebo (n = 66) gum while travelling on a non-smoking train. Outcome measures were ratings of craving and mood withdrawal symptoms prior to treatment and at regular intervals during abstinence. In a multivariate analysis of all symptoms, there was no interaction between treatment and time [F(21,110) = 1.28, p = 0.20, $$ \eta_{\mathrm{p}}^2 $$ = 0.20] nor an effect of treatment [F(7,124) = 0.45, p = 0.87, $$ \eta_{\mathrm{p}}^2 $$ = 0.03]. There was an effect of time [F(21,110) = 11.59, p

Background A recent rigorous study has shown that cytisine, a low-cost drug, is effective for smoking cessation. A number of earlier studies exist, mostly from former communist countries where cytisine has been used since the 1960s. The key question now is whether there is sufficient evidence to warrant licensing cytisine or whether more work is needed. A systematic review was undertaken to assess the efficacy of cytisine in smoking cessation. Methods The Cochrane Library, CINAHL, Embase, Medline and PsycINFO databases were searched for relevant data. Data from controlled trials were entered into two separate meta-analyses. The first considered the strictest definition of outcome and longest follow-up from all available studies and the second pooled outcomes from studies with biochemically validated abstinence and follow-up of 6 months or longer. Results Eight controlled trials were identified. Seven trials provided extractable data and, when pooled (first meta-analysis), produced a risk ratio (RR) of 1.57 (95% CI 1.42 to 1.74). Data from two high-quality studies (second meta-analysis) produced a pooled RR of 3.29 (95% CI 1.84 to 5.90). Patients on cytisine reported more gastrointestinal symptoms than patients on placebo (RR=1.76, 95% CI 1.28 to 2.42). There was no difference in overall reports of adverse events and no specific safety concerns emerged. Conclusions Cytisine is an effective treatment for smoking cessation with efficacy comparable to that of other currently licensed treatments. Given its low cost and potential for public health benefit, expedited licensing of cytisine for smoking cessation is warranted.

The UK is a global leader in stop-smoking support—providing free behavioral support and cessation medication via stop smoking services (SSS) without charge to smokers. This study aimed to explore the client and service characteristics associated with abstinence 52 weeks after quitting. A prospective cohort study of 3057 SSS clients in nine different areas of England who began their quit attempt between March 2012 and March 2013 was conducted. Important determinants of long-term quitting were assessed through quit rates and multivariable logistic regression. Our results showed that the overall weighted carbon monoxide validated quit rate for clients at 52 weeks was 7.7% (95% confidence interval (CI) 6.6–9.0). The clients of advisors, whose main role was providing stop-smoking support, were more likely to quit long-term than advisors who had a generalist role in pharmacies or general practices (odds ratio (OR) 2.3 (95% CI 1.2–4.6)). Clients were more likely to achieve abstinence through group support than one-to-one support (OR 3.4 (95% CI 1.7–6.7)). Overall, one in thirteen people who set a quit date with the National Health Service (NHS) Stop-Smoking Service maintain abstinence for a year. Improving abstinence is likely to require a greater emphasis on providing specialist smoking cessation support. Results from this study suggest that over 18,000 premature deaths were prevented through longer-term smoking cessation achieved by smokers who accessed SSS in England from March 2012 to April 2013, but outcomes varied by client characteristic and the type of support provided.

To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups.Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer.Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01).Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups.This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups.

© 2014 The Cochrane Collaboration. Background: Electronic cigarettes (ECs) are electronic devices that heat a liquid - usually comprising propylene glycol and glycerol, with or without nicotine and flavours, stored in disposable or refillable cartridges or a reservoir - into an aerosol for inhalation. Since ECs appeared on the market in 2006 there has been a steady growth in sales. Smokers report using ECs to reduce risks of smoking, but some healthcare organisations have been reluctant to encourage smokers to switch to ECs, citing lack of evidence of efficacy and safety. Smokers, healthcare providers and regulators are interested to know if these devices can reduce the harms associated with smoking. In particular, healthcare providers have an urgent need to know what advice they should give to smokers enquiring about ECs. Objectives: To examine the efficacy of ECs in helping people who smoke to achieve long-term abstinence; to examine the efficacy of ECs in helping people reduce cigarette consumption by at least 50% of baseline levels; and to assess the occurrence of adverse events associated with EC use. Search methods: We searched the Cochrane Tobacco Addiction Groups Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two other databases for relevant records from 2004 to July 2014, together with reference checking and contact with study authors. Selection criteria: We included randomized controlled trials (RCTs) in which current smokers (motivated or unmotivated to quit) were randomized to EC or a control condition, and which measured abstinence rates or changes in cigarette consumption at six months or longer. As the field of EC research is new, we also included cohort follow-up studies with at least six months follow-up. We included randomized cross-over trials and cohort follow-up studies that included at least one week of EC use for assessment of adverse events. Data collection and analysis: One review author extracted data from the included studies and another checked them. Our main outcome measure was abstinence from smoking after at least six months follow-up, and we used the most rigorous definition available (continuous, biochemically validated, longest follow-up). For reduction we used a dichotomous approach (no change/reduction < 50% versus reduction by 50% or more of baseline cigarette consumption). We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for each study, and where appropriate we pooled data from these studies in meta-analyses. Main results: Our search identified almost 600 records, from which we include 29 representing 13 completed studies (two RCTs, 11 cohort). We identified nine ongoing trials. Two RCTs compared EC with placebo (non-nicotine) EC, with a combined sample size of 662 participants. One trial included minimal telephone support and one recruited smokers not intending to quit, and both used early EC models with low nicotine content. We judged the RCTs to be at low risk of bias, but under the GRADE system the overall quality of the evidence for our outcomes was rated 'low' or 'very low' because of imprecision due to the small number of trials. A 'low' grade means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. A 'very low' grade means we are very uncertain about the estimate. Participants using an EC were more likely to have abstained from smoking for at least six months compared with participants using placebo EC (RR 2.29, 95% CI 1.05 to 4.96; placebo 4% versus EC 9%; 2 studies; GRADE: low). The one study that compared EC to nicotine patch found no significant difference in six-month abstinence rates, but the confidence intervals do not rule out a clinically important difference (RR 1.26, 95% CI: 0.68 to 2.34; GRADE: very low). A higher number of people were able to reduce cigarette consumption by at least half with ECs compared with placebo ECs (RR 1.31, 95% CI 1.02 to 1.68, 2 studies; placebo: 27% versus EC: 36%; GRADE: low) and compared with patch (RR 1.41, 95% CI 1.20 to 1.67, 1 study; patch: 44% versus EC: 61%; GRADE: very low). Unlike smoking cessation outcomes, reduction results were not biochemically verified. None of the RCTs or cohort studies reported any serious adverse events (SAEs) that were considered to be plausibly related to EC use. One RCT provided data on the proportion of participants experiencing any adverse events. Although the proportion of participants in the study arms experiencing adverse events was similar, the confidence intervals are wide (ECs vs placebo EC RR 0.97, 95% CI 0.71 to 1.34; ECs vs patch RR 0.99, 95% CI 0.81 to 1.22). The other RCT reported no statistically significant difference in the frequency of AEs at three- or 12-month follow-up between the EC and placebo EC groups, and showed that in all groups the frequency of AEs (with the exception of throat irritation) decreased significantly over time. Authors' conclusions: There is evidence from two trials that ECs help smokers to stop smoking long-term compared with placebo ECs. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low' by GRADE standards. The lack of difference between the effect of ECs compared with nicotine patches found in one trial is uncertain for similar reasons. ECs appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo ECs and nicotine patches, but the above limitations also affect certainty in this finding. In addition, lack of biochemical assessment of the actual reduction in smoke intake further limits this evidence. No evidence emerged that short-term EC use is associated with health risk.

Aims The NHS Stop Smoking Service (NHS-SSS) helps approximately half its clients to quit for 4 weeks. However, most initially successful quitters relapse within 6 months. Short message service (SMS) texting has been shown to facilitate stopping smoking. We describe the development, implementation and subsequent evaluation, in terms of practicability and client response, of an SMS text-based relapse prevention intervention (RPI) delivered within routine community and specialist National Health Service (NHS) Stop Smoking Service (SSS) provision in four Primary Care Trusts. Design Text messages aimed at motivation to remain abstinent, preventing careless lapses and continuing the full course of medicine for smoking cessation were developed and sent weekly to clients' mobile phones for 12 weeks and fortnightly for 6 months. They were asked to respond to some of the texts and contact the NHS SSS if they lapsed. They were also offered free nicotine mini lozenges to be sent via the mail on three occasions. Setting NHS SSS. Participants 202 clients who had been abstinent for 4 weeks. Measurements Feasibility of introducing RPI into routine care; response to interactive messages and requests for the medication; rating of the helpfulness of RPI; self-reported and carbon monoxide (CO)-validated smoking status for up to 26 weeks. Findings A text-based RPI was easy to implement within the NHS SSS provided by specialist advisers, but enrolment of clients from services provided by a network of pharmacists was difficult because client contact details were often lacking. Where records of the number of people invited to RPI were available, 94% of eligible participants enrolled. The RPI was well received by both SSS clients and staff, with 70% (n = 63) of clients who completed follow-up considering the intervention helpful. Eighty-five per cent (n = 172) of clients responded to at least one of the nine interactive text messages. Sixty-four clients (32% of the total, 47% of those we managed to contact) reported continuous abstinence at 6 months. Eighteen (9%) clients who relapsed to smoking used the RPI to re-engage with the NHS SSS and 10 (5%) successfully re-established abstinence. Conclusions In smokers attending National Health Service Stop Smoking Services who are abstinent 4 weeks after their quit date, a relapse prevention intervention based on SMS text messaging was well received, and can be implemented economically and rapidly. A controlled trial is needed to establish whether it has a significant impact on relapse.

Aim To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit. Design Single-blind, parallel randomized trial. Setting New Zealand. Participants Smokers who called the Quitline for quitting support were randomized to either VLNC cigarettes to use whenever they had an urge to smoke for up to 6 weeks after their quit date, in combination with usual Quitline care (8 weeks of NRT patches and/or gum or lozenges, plus behavioural support) or to usual Quitline care alone. Measurements The primary outcome was 7-day point-prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, self-efficacy, alcohol use, serious adverse events and views on the use of the VLNC cigarettes at 3 and 6 weeks and 3 and 6 months. Findings A total of 1410 participants were randomized (705 in each arm), with a 24% loss to follow-up at 6 months. Participants in the intervention group were more likely to have quit smoking at 6 months compared to the usual care group [7-day point-prevalence abstinence 33 versus 28%, relative risk (RR) = 1.18, 95% confidence interval (CI): 1.01, 1.39, P = 0.037; continuous abstinence 23 versus 15%, RR = 1.50, 95% CI: 1.20, 1.87, P = 0.0003]. The median time to relapse in the intervention group was 2 months compared to 2 weeks in the usual care group (P

Current treatments for smoking cessation such as nicotine replacement therapy or varenicline address the primary reinforcer of smoking (nicotine), but sensorimotor stimuli (e.g. smell/taste of smoke, inhaling/exhaling, airway sensations, holding the cigarette) may act as secondary reinforcers and also contribute to smoking reward. Addressing both these aspects of smoking may help to enhance smoking cessation treatment. The aim of this review was to examine whether sensorimotor replacement can help to alleviate craving and aid smoking cessation. Three sensorimotor replacement products were examined: non-nicotine inhalators/aerosols, de-nicotinised cigarettes and electronic cigarettes. The current research suggests that sensorimotor replacement may enhance the efficacy of nicotine replacement therapy, but is unlikely to be useful if used alone. Electronic cigarettes may be the most promising approach, due to the combination of nicotine delivery and sensorimotor input.

Individual differences in the rate of nicotine metabolism (RNM) could be related to dependence and success in stopping smoking. A range of studies have examined RNM measured by the ratio of trans-3′-hydroxycotinine and cotinine in body fluids (the ratio). A systematic review of this literature is needed to draw conclusions and identify gaps in evidence. The aim of this study is to review evidence on the association of the ratio to cigarette dependence and its role in individual tailoring of smoking cessation pharmacotherapy. We reviewed 27 studies of the ratio related to its reliability, validity, and relationship to dependence. The ratio is a reasonably accurate proxy for RNM. There is little evidence that the ratio is related to questionnaire measures of dependence, though the existing data are limited and the ratio has been linked to smoking at night and to some aspects of smoking topography. The ratio is also only weakly associated with cigarette consumption. Its relationship to the severity of withdrawal symptoms seems also weak at best, but limited data exist. One study suggests the ratio predicts outcome of unaided quitting. Importantly, the ratio seems to predict responses both to NRT and bupropion, and thus could guide pharmacotherapy. The evidence that the ratio is related to smoking behaviours and to cigarette dependence is limited, but the ratio seems to influence treatment response to two stop smoking medications. Further studies of the relationship between the ratio and cigarette dependence and trials of ratio-guided pharmacotherapy are needed.

Aims To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Design Single-blind, random- ized controlled trial. Setting New Zealand. Participants A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. Measurements The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. Findings No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allo- cated to the intervention group were more likely to have quit smoking at 3 months (self-reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03), had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). Conclusions In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period.

Background Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Māori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

Aims Many smokers believe that smoking helps them to cope with stress, and that stopping smoking would deprive them of an effective stress management tool. Changes in stress levels following long-term smoking cessation are not wellmapped.Thislongitudinalprojectwasdesignedtoprovidemorerobustdataonpost-cessationchangesinperceived stress levels by following a cohort of smokers admitted to hospital after myocardial infarction (MI) or for coronary artery bypass (CAB) surgery, as such patients typically achieve higher continuous abstinence rates than other comparablesamples.Design Atotalof 469smokershospitalizedafterMIorCABsurgeryandwantingtostopsmokingwere seeninthehospitalandcompleted1-yearfollow-ups.Ratingsof helpfulnessof smokinginmanagingstressatbaseline, smoking status (validated by salivary cotinine concentration) and ratings of perceived stress at baseline and at 1-year follow-upwerecollected.Findings Of thepatients,41%(n = 194)maintainedabstinencefor1year.Futureabstainers and future smokers did not differ in baseline stress levels or in their perception of coping properties of smoking. However,abstainersrecordedasignificantlylargerdecreaseinperceivedstressthancontinuingsmokers,andtheresult held when possible confounding factors were controlled for (P < 0.001). Conclusions In highly dependent smokers whoreportthatsmokinghelpsthemcopewithstress,smokingcessationisassociatedwithloweringof stress.Whatever

To measure the short-term effects of an electronic nicotine delivery device ("e cigarette", ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects.Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD.University research centre in Auckland, New Zealand.40 adult dependent smokers of 10 or more cigarettes per day.Participants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product.The primary outcome was change in desire to smoke, measured as "area under the curve" on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured.Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min.The 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed. Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register.

Aims To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence. Design In a within-subject, cross-over trial participants were randomly assigned Zonnic® nicotine mouth spray (1 mg/spray), Zonnic® nicotine lozenge (2.5 mg), Nicorette® gum (4 mg) and placebo lozenge on each of four study days. Setting University research unit. Participants Forty-seven dependent adult smokers. Measurements Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis. Findings All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of −14.5 (95% CI: −23.0 to −6.0) and −10.6 (95% CI: −19.1 to −2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated. Conclusions The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief.

This study investigated smokers' ratings of putative smoking motives and how these relate to smoking patterns, withdrawal symptoms, and short-term abstinence in clients attending smokers' clinics. Data were collected from 2,727 clients from two London Stop Smoking Services that offered behavioral support combined with pharmacotherapy. On a scale of 1 to 5, stress relief (M = 3.9), boredom relief (3.7), and enjoyment (3.6) were rated highest. Uses as an aid to concentration (2.9), for relief of withdrawal discomfort (2.8), and as an aid to socialization (2.8) received moderate ratings. Weight control was rated low (2.0). These ratings were found to be largely independent of each other. Ratings of enjoyment, boredom relief, improvement in concentration, and relief of withdrawal discomfort were positively correlated with daily cigarette consumption (p