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Abstract: Background and aims: This narrative review aimed to provide a brief overview of five key research ‘classics’ produced by the innovative and radical thought leader, Professor Michael Anthony Hamilton Russell (1932–2009), drawing upon his other work wherever feasible. Methods: Narrative review. From more than 250 publications, we selected papers we considered seminal texts, published in 1971, 1976, 1978, 1979 and 1991. Results: Russell was among the first researchers to explain that smoking was a dependence disorder caused by the drug nicotine decades before this was recognized formally. He therefore saw quickly the importance of delivering nicotine in a less harmful format as a way of controlling nicotine withdrawal when stopping smoking, first studying nicotine gum. In addition to pharmacotherapies, Russell's research also explored the role of behavioural support, particularly the role of general practitioners (GPs), alone as well as supported by specialist clinics; this research underpinned initiatives in England to reimburse doctors for giving advice to smokers, and to provide a national network of smoking cessation services. Research on nicotine uptake from other delivery systems and routes led Russell to theorize that the speed and dose of delivery impacted upon the effectiveness of a product to act as a substitute for smoking. He commented on the addictiveness of the high nicotine boli delivered in quick succession when smoking cigarettes and argued that alternative recreational nicotine delivery systems would need to be promoted actively to smokers in order for them to compete with cigarettes, a forerunner for contemporary debates on electronic cigarettes. Conclusions: The legacy of Russell's landmark research is seen in present‐day nicotine science, policy and discourse. [ABSTRACT FROM AUTHOR]

Background and Aims Despite decades of research on co-occurring smoking and depression, cessation rates remain consistently lower for depressed smokers than for smokers in the general population, highlighting the need for theory-driven models of smoking and depression. This paper provides a systematic review with a particular focus upon psychological states that disproportionately motivate smoking in depression, and frame an incentive learning theory account of smoking-depression co-occurrence. Methods We searched PubMed, Scopus, PsychINFO and CINAHL to December 2014, which yielded 852 papers. Using pre-established eligibility criteria, we identified papers focused on clinical issues and motivational mechanisms underlying smoking in established, adult smokers (i.e. maintenance, quit attempts and cessation/relapse) with elevated symptoms of depression. Two reviewers determined independently whether papers met review criteria. We included 297 papers in qualitative synthesis. Results Our review identified three primary mechanisms that underlie persistent smoking among depressed smokers: low positive affect, high negative affect and cognitive impairment. We propose a novel application of incentive learning theory which posits that depressed smokers experience greater increases in the expected value of smoking in the face of these three motivational states, which promotes goal-directed choice of smoking behavior over alternative actions. Conclusions The incentive learning theory accounts for current evidence on how depression primes smoking behavior and provides a unique framework for conceptualizing psychological mechanisms of smoking maintenance among depressed smokers. Treatment should focus upon correcting adverse internal states and beliefs about the high value of smoking in those states to improve cessation outcomes for depressed smokers. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Although smoking cessation medications have shown effectiveness in increasing abstinence in randomized controlled trials (RCTs), it is unclear to what extent benefits persist over time. This paper assesses whether the benefits of smoking cessation medications decline over the first year. Methods: We selected studies from three systematic reviews published by the Cochrane Collaboration. RCTs of first‐line smoking cessation medications, with 6‐ and 12‐month follow‐up, were eligible for inclusion. Meta‐analysis was used to synthesize information on sustained abstinence (SA) at 6 versus 12 months and 3 versus 6 months, using the risk difference (RD) (‘net benefit’) between intervention and control group quit rates, the relative risk (RR) and the odds ratio (OR). Results: Sixty‐one studies (27 647 participants) were included. Fewer than 40% of intervention group participants were sustained abstinent at 3 months (bupropion: 37.1%; nicotine replacement therapy (NRT): 34.8%; varenicline: 39.3%); approximately a quarter were sustained abstinent at 6 months (bupropion: 25.9%; NRT: 26.6%; varenicline: 25.4%), and approximately a fifth were sustained abstinent at 12 months (bupropion: 19.9%; NRT: 19.8%%; varenicline: 18.7%). There was only a small decline in RR (3 months: 1.95 [95% confidence interval (CI) = 1.74–2.18, P < 0.0001]; 6 months: 1.87 (95% CI = 1.67–2.08 P < 0.0001); 12 months: 1.75 (95% CI = 1.56–1.95, P < 0.0001) between intervention and control groups over time, but a substantial decline in net benefit [3 months: RD = 17.3% (14.5–20.1%); 6 months: RD = 11.8% (10.0–13.7%); 12 months: RD = 8.2% (6.8–9.6%)]. The decline in net benefit was statistically significant between 3 and 6 [RD = 4.95% (95% CI = 3.49–6.41%), P < 0.0001] and 6 and 12 months [RD = 3.00% (95% CI = 2.36%–3.64%), P < 0.0001)] for medications combined and individual medications. Conclusions: The proportion of smokers who use smoking cessation medications who benefit from doing so decreases during the course of the first year, but a net benefit still remains at 12 months. [ABSTRACT FROM AUTHOR]

Aims This paper provides a concise review of the efficacy, effectiveness and affordability of health-care interventions to promote and assist tobacco cessation, in order to inform national guideline development and assist countries in planning their provision of tobacco cessation support. Methods Cochrane reviews of randomized controlled trials (RCTs) of major health-care tobacco cessation interventions were used to derive efficacy estimates in terms of percentage-point increases relative to comparison conditions in 6-12-month continuous abstinence rates. This was combined with analysis and evidence from 'real world' studies to form a judgement on the probable effectiveness of each intervention in different settings. The affordability of each intervention was assessed for exemplar countries in each World Bank income category (low, lower middle, upper middle, high). Based on World Health Organization (WHO) criteria, an intervention was judged as affordable for a given income category if the estimated extra cost of saving a life-year was less than or equal to the per-capita gross domestic product for that category of country. Results Brief advice from a health-care worker given opportunistically to smokers attending health-care services can promote smoking cessation, and is affordable for countries in all World Bank income categories (i.e. globally). Proactive telephone support, automated text messaging programmes and printed self-help materials can assist smokers wanting help with a quit attempt and are affordable globally. Multi-session, face-to-face behavioural support can increase quit success for cigarettes and smokeless tobacco and is affordable in middle- and high-income countries. Nicotine replacement therapy, bupropion, nortriptyline, varenicline and cytisine can all aid quitting smoking when given with at least some behavioural support; of these, cytisine and nortriptyline are affordable globally. Conclusions Brief advice from a health-care worker, telephone helplines, automated text messaging, printed self-help materials, cytisine and nortriptyline are globally affordable health-care interventions to promote and assist smoking cessation. Evidence on smokeless tobacco cessation suggests that face-to-face behavioural support and varenicline can promote cessation. [ABSTRACT FROM AUTHOR]

Aims The Cochrane Collaboration is an international not-for profit organization which produces and disseminates systematic reviews. This paper is the second in a series of annual updates of Cochrane reviews on tobacco addiction interventions, covering new and updated reviews from 2013. Methods In 2013, the Group published two new reviews and updated 11 others. This update summarizes and comments on these reviews as well as on a review of psychosocial interventions for smoking cessation in pregnant women, and presents pooled results from reviews of cessation interventions. Results New reviews in 2013 found: low-quality evidence that behavioural interventions with mood management components could significantly increase long-term quit rates in people with current [risk ratio (RR) = 1.47, 95% confidence interval (CI) = 1.13–1.92) and past (RR = 1.41, 95% CI = 1.13–1.77] depression; evidence from network meta-analysis that varenicline and combined forms of nicotine replacement therapy (NRT) are associated with higher quit rates than bupropion or single-form NRT (varenicline versus single-form NRT odds ratio (OR) = 1.57, 95% credibility interval (CredI) = 1.29–1.91; versus bupropion OR = 1.59, 95% CredI = 1.29–1.96); and no evidence of a significant increase in serious adverse events in trial participants randomized to varenicline or bupropion when compared to placebo controls. New evidence emerging from updated reviews suggests that counselling interventions can increase quit rates in pregnant women and that school-based smoking programmes with social competence curricula can lead to a significant reduction in uptake of smoking at more than a year. Updated reviews also suggested that naltrexone, selective serotonin re-uptake inhibitors and St John’s wort do not have a significant effect on long-term smoking cessation. Conclusions Cochrane systematic review evidence from 2013 suggests that adding mood management to behavioural support may improve cessation outcomes in smokers with current or past depression and strengthens evidence for previous conclusions, including the safety of varenicline and bupropion and the benefits of behavioural support for smoking cessation in pregnancy. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims There is a growing interest in very low rate [fewer than one cigarette per day (CPD)] and light (one to nine CPD) smokers and in some parts of the world their numbers appear to be increasing. This paper examined changes in prevalence over the past 5 years, cessation patterns, and smoking and demographic characteristics of very low rate, light and moderate-to-heavy (10+ CPD) smokers in England. Design Cross-sectional and longitudinal data from aggregated monthly waves of a household survey: the Smoking Toolkit Study. Setting England. Participants A total of 23 245 smokers interviewed between November 2006 and May 2011 and 4147 who provided data at 6-month follow-up. Measurements We compared the demographic and smoking characteristics between the three groups of smokers at baseline, and the rate of attempts to quit, use of aids to cessation and success of quit attempts at follow-up. Findings Very low rate smoking remained extremely rare (1.9% of smokers in 2006 to 2.8% in 2011), but light smoking became increasingly common (23.9-32.8%). Compared with moderate-to-heavy smokers, very low rate and light smokers were younger, more often female and from a higher socio-economic background. They were more motivated to quit and enjoyed smoking less. During the 6-month follow-up period, light smokers, but not very low rate smokers, were more likely to attempt to quit than moderate-to-heavy smokers. When they tried to quit, very low rate and light smokers used aids to cessation less than moderate-to-heavy smokers but still used them to a substantial degree: 18%, 31% and 44% used over-the-counter nicotine replacement therapy in their most recent quit attempt for the three types of smoker, respectively. Even very low rate smokers had a substantial failure rate: 65% failed in their most recent quit attempt within 6 months. Conclusions Very low rate (fewer than one cigarette per day) and light (one to nine cigarettes per day) smokers in England are at least as motivated to quit as heavier smokers. Although they use cessation medication less than heavier smokers and are more likely to succeed, they still use such medication and fail in quit attempts to a substantial degree. [ABSTRACT FROM AUTHOR]

Prescribing nicotine replacement therapy (NRT) or bupropion for smoking cessation is of considerable importance to public health but little is known about prescribing practices. This paper examines general practitioners’ (GPs’) prescribing patterns in Britain where these drugs are reimbursed. The results have implications for other health-care systems considering introducing reimbursement.Postal survey conducted in 2002 of a random sample of 1088 GPs in England and Wales, of whom 642 (59%) responded.Number of requests GPs reported having received from patients for NRT and bupropion over the past month, the number of prescriptions they reported issuing and ratings of attitudes to these medications.GPs reported receiving an average of 4.3 requests for NRT and 1.9 for bupropion in the previous month. They reported issuing 3.5 prescriptions for NRT and 1.2 for bupropion. Almost all GPs accepted that NRT (95%) and bupropion (97%) should be reimbursable on National Health Service (NHS) prescription. However, a significant minority of those who received requests for prescriptions did not issue any (8% for NRT and 26% for bupropion). This was related to whether they thought these products should be available on NHS prescription for both NRT and bupropion (OR = 0.66,P < 0.05), which in turn was related to beliefs about whether smokers should have to pay for treatment themselves, the cost-effectiveness of NRT/bupropion and the low priority they would give NRT/bupropion in the drug budget. For bupropion, concern about side-effects independently predicted not prescribing[odds ratio (OR) = 1.46,P < 0.03].In the British health-care system, which has a well-established system for technology assessment and professionally endorsed guidelines, a significant minority of GPs decline all patient requests for stop-smoking medicines. [ABSTRACT FROM AUTHOR]

Background and aims: Non‐daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non‐daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations. Design Within a 6‐week randomized, placebo‐controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used. Setting: Smoking cessation research clinic in Pittsburgh, PA, USA. Participants: A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation. Intervention: Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as‐needed dosing instructions. Measurements Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable. Findings Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22–0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78–3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06). Conclusions: When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non‐daily smokers. [ABSTRACT FROM AUTHOR]

Background and Aims: Understanding whether and how far smokers' characteristics influence the effectiveness of treatment may be important for tailoring recommendations on cessation aids to those most likely to help the user achieve abstinence. This study aimed to estimate the effectiveness of commonly used smoking cessation aids and test whether their effectiveness differs according to cigarette addiction, socio‐economic status, age or sex. Design Correlational design using cross‐sectional survey data collected monthly between 2006 and 2018. Setting: England. Participants: A total of 18 929 adults (aged ≥ 16 years, 52.0% female) who had smoked within the previous 12 months and had made at least one quit attempt during that period. Measurements The outcome was self‐reported abstinence from quit date to survey. Independent variables were self‐reported use during the most recent quit attempt of: prescription nicotine replacement therapy (NRT), NRT over‐the‐counter, varenicline, bupropion, e‐cigarettes, face‐to‐face behavioural support, telephone support, written self‐help materials, websites and hypnotherapy. Moderators were cigarette addiction, social grade, age and sex. Findings After adjustment for covariates and use of other cessation aids, users of e‐cigarettes [odds ratio (OR) = 1.95, 95% confidence interval (CI) = 1.69–2.24] and varenicline (OR = 1.82, 95% CI = 1.51–2.21) had significantly higher odds of reporting abstinence than those who did not report use of these cessation aids. Use of prescription NRT was associated with increased abstinence in older (≥ 45 years) (OR = 1.58, 95% CI = 1.25–2.00) but not younger (< 45 years) smokers (OR = 1.09, 95% CI = 0.85–1.42). Use of websites was associated with increased abstinence in smokers from lower (OR = 2.20, 95% CI = 1.22–3.98) but not higher social grades (OR = 0.74, 95% CI = 0.40–1.38). There was little evidence of benefits of using other cessation aids. Conclusions: Use of e‐cigarettes and varenicline are associated with higher abstinence rates following a quit attempt in England. Use of prescription of nicotine replacement therapy is also associated with higher abstinence rates, but only in older smokers, and use of websites only in smokers from lower socio‐economic status. [ABSTRACT FROM AUTHOR]

Background and aims: Cost‐effectiveness studies in randomized clinical trials have shown that tobacco cessation pharmacotherapy is among the most cost‐effective of health‐care interventions. Clinical trial eligibility criteria and treatment protocols may not be followed in actual practice. This study aimed to determine whether tobacco cessation pharmacotherapy is cost‐effective in real‐world settings. Design A retrospective analysis of costs and outcomes. Setting: Hospitals and clinics of the US Veterans Health Administration, USA. Participants: A total of 589 862 US veterans who screened positive for tobacco use in 2011. Intervention and comparator: Tobacco users who initiated smoking cessation pharmacotherapy in the 6 months after screening were compared with those who did not use pharmacotherapy in this period. Pharmacotherapy included nicotine replacement therapy, bupropion (if prescribed at 300 mg per day or specifically for tobacco cessation) or varenicline. Measures: Effectiveness was determined from responses to a subsequent tobacco screening conducted between 7 and 18 months after the treatment observation period. Cost of medications and prescribing health‐care encounters was determined for the period between initial and follow‐up tobacco use screening. Multivariate fixed‐effects regression was used to assess the effect of initial treatment status on cost and outcome while controlling for differences in case‐mix with propensity weighting to adjust for confounding by indication. Findings Thirteen per cent of participants received tobacco cessation pharmacotherapy within 6 months of initial screening. After an average of an additional 218.1 days' follow‐up, those who initially received pharmacotherapy incurred $143.79 in additional treatment cost and had a 3.1% absolute increase in tobacco quit rates compared with those who were not initially treated. This represents an incremental cost‐effectiveness ratio of $4705 per quit. The upper limit of the 99.9% confidence region was $5600 per quit. Without propensity adjustment, the cost‐effectiveness ratio was $7144 per quit, with the upper limit of the 99.9% confidence region $9500/quit. Conclusions: Tobacco cessation pharmacotherapy provided by the US Veterans Health Administration in 2011/12 was cost‐effective in this real‐world setting, with an incremental cost‐effectiveness ratio of $4705 per quit. [ABSTRACT FROM AUTHOR]

Background and aim: It is useful, for theoretical and practical reasons, to be able to specify functions for continuous abstinence over time in smoking cessation attempts. This study aimed to find the best‐fitting models of mean proportion abstinent with different smoking cessation pharmacotherapies up to 52 weeks from the quit date. Methods: We searched the Cochrane Database of Systematic Reviews to identify randomized controlled trials (RCTs) of pharmacological treatments to aid smoking cessation. For comparability, we selected trials that provided 12 weeks of treatment. Continuous abstinence rates for each treatment at each follow‐up point in trials were extracted along with methodological details of the trial. Data points for each pharmacotherapy at each follow‐up point were aggregated where the total across contributing studies included at least 1000 participants per data point. Continuous abstinence curves were modelled using a range of different functions from the quit date to 52‐week follow‐up. Models were compared for fit using R2 and Bayesian information criterion (BIC). Results: Studies meeting our selection criteria covered three pharmacotherapies [varenicline, nicotine replacement therapy (NRT) and bupropion] and placebo. Power functions provided the best fit (R2 > 0.99, BIC < 17.0) to continuous abstinence curves from the target quit date in all cases except for varenicline, where a logarithmic function described the curve best (R2 = 0.99, BIC = 21.2). At 52 weeks, abstinence rates were 22.5% (23.0% modelled) for varenicline, 16.7% (16.0% modelled) for bupropion, 13.0% (12.4% modelled) for NRT and 8.3% (8.9% modelled) for placebo. For varenicline, bupropion, NRT and placebo, respectively, 55.9, 65.0, 62.3 and 56.5% of participants who were abstinent at the end of treatment were still abstinent at 52 weeks. Conclusions: Mean continuous abstinence rates up to 52 weeks from initiation of smoking cessation attempts in clinical trials can be modelled using simple power functions for placebo, nicotine replacement therapy and bupropion and a logarithmic function for varenicline. This allows accurate prediction of abstinence rates from any time point to any other time point up to 52 weeks. [ABSTRACT FROM AUTHOR]

Background and Aims: Waterpipe tobacco smoking is a growing public health concern. There is limited research using pharmacotherapy and no research using varenicline (established treatment for smoking cessation) in waterpipe smokers. We tested the efficacy of varenicline in achieving abstinence from all tobacco use among waterpipe smokers. Design Two‐arm, parallel group, placebo‐controlled, double‐blind, multi‐centre (n = 4), individually randomized trial with follow‐up to 25 weeks. Settings District general hospitals and catchment communities within four districts of Punjab, Pakistan. Participants: Adult daily waterpipe smokers (n = 510; 253 in varenicline and 257 in placebo arms), who were interested in quitting, were recruited and analysed between March and November 2016. Of these, 220 (87%) in the varenicline and 239 (93%) in the placebo arms completed all follow‐ups. Participants were on average aged 49 [standard deviation (SD) = 15.2] years, daily smokers and smoked for the last 27 (SD = 15.9) years. More than half (261, 51.2%) also smoked cigarettes. Intervention and comparator: All trial participants received two structured sessions of behavioural support (of 30 and 10 minutes) one at the time of registration and the other 1 week later. Participants were randomized to varenicline (active arm) and placebo (control arm) stratified on district, sex and concomitant cigarette smoking. Varenicline and placebo were dispensed as identical unlabelled tablets for 12 weeks: 0.5 mg for 1 week (once on days 1–3, twice on days 4–7) and 1 mg for the subsequent 11 weeks (twice daily). Measurements The trial participants were followed‐up for a period of 25 weeks post‐randomization. The primary outcome was 7‐day repeated point prevalence abstinence from all forms of tobacco, self‐reported at each of weeks 5, 12 and 25, verified by carbon‐monoxide cut‐off < 10 parts per million. Findings No evidence of statistically significant difference in repeated point prevalence abstinence between the varenicline (12 of 253; 4.7%) and placebo (11 of 257; 4.3%) arms (relative risk = 1.11, 95% confidence interval = 0.50–2.47, P = 0.80) was observed (Bayes factor = 0.048). Adverse events reported in 27 participants were 34 (15 in varenicline and 19 in placebo); none was serious. Conclusions: Varenicline was not more effective than placebo in aiding cessation of tobacco use in long‐term daily waterpipe smokers. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To assess (1) how far the efficacies of front‐line smoking cessation pharmacotherapies vary as a function of smoker characteristics and (2) associations between these characteristics and success of smoking cessation attempts. Design: Prospective correlational study in the context of a double‐blind randomized trial. The outcome was regressed individually onto each covariate after adjusting for treatment, and then a forward stepwise model constructed. Treatment moderator effects of covariates were tested by treatment × covariate interactions. Setting: Health service facilities in multiple countries. Participants: Data came from 8120 smokers willing to make a quit attempt, randomized to varenicline, bupropion, nicotine replacement therapy (NRT) or placebo in Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) between 30 November 2011 and 13 January 2015. Measurements: Smoker characteristics measured at baseline were country, psychiatric history, sex, age, body mass index (BMI), ethnic group, life‐time suicidal ideation/behaviour, anxiety, depression, aggression, psychotropic medication, history of alcohol/substance use disorder, age of starting smoking, cigarette dependence [Fagerström Test for Cigarette Dependence (FTCD)] and prior use of study medicines. Outcome was biochemically confirmed continuous abstinence at weeks 9–24 from start of treatment. Findings: No statistically significant treatment × covariate interactions were found. Odds of success were associated independently positively with age [odds ratio (OR) = 1.01; 95% confidence interval (CI) = 1.00, 1.01], BMI (1.01; 95% CI = 1.00, 1.02) and age of starting smoking (1.03; 95% CI = 1.02, 1.04). Odds were associated independently negatively with US (versus non‐US) study site (0.53; 95% CI = 0.46, 0.61), black (versus white) ethnic group (0.57; 95% CI = 0.45, 0.72), mood disorder (0.85; 95% CI = 0.73, 0.99), anxiety disorder (0.71; 95% CI = 0.55, 0.90) and psychotic disorder (0.73; 95% CI = 0.50, 1.07), taking psychotropic medication (0.81; 95% CI = 0.68, 0.95), FTCD (0.89; 95% CI = 0.87, 0.92) and previous use of NRT (0.78; 95% CI = 0.67, 0.91). Conclusions: While a range of smoker characteristics—including psychiatric history, cigarette dependence and prior use of nicotine replacement therapy (NRT)—are associated with lower cessation rates, they do not substantially influence the efficacy of varenicline, bupropion or NRT. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To investigate whether smokers prescribed varenicline had lower risks of serious ill‐health during the 4 years following treatment compared with those prescribed nicotine replacement therapy (NRT). Design: Observational cohort study of electronic medical records. Setting: A total of 370 UK general practices sampled from the Clinical Practice Research Datalink. Participants: A total of 126 718 patients aged 18 and over who were issued smoking cessation prescriptions between 1 September 2006 and 31 March 2014. Measurements: Our primary outcome was all‐cause mortality within 2 years of first prescription as indicated by linked Office of National Statistics data. Our secondary outcomes were cause‐specific mortality, all‐cause, cause‐specific hospitalization, primary care diagnosis of myocardial infarction or chronic obstructive pulmonary disease (COPD), body mass index and attendance rate to primary care within 2 years of first prescription. Risk differences and 95% confidence intervals were estimated by multivariable adjusted regression and propensity score matched regression. We used instrumental variable analysis to overcome residual confounding. Findings: People prescribed varenicline were healthier at baseline than those prescribed NRT in almost all characteristics, highlighting the potential for residual confounding. Our instrumental variable analysis results found that people prescribed varenicline had a similar risk of mortality at 2 years [risk difference per 100 patients treated = 0.67, 95% confidence interval (CI) = ‐0.11 to 1.46)] to those prescribed NRT, and there were similar rates of all‐cause hospitalization, incident primary‐care diagnoses of myocardial infarction and COPD. People prescribed varenicline subsequently attended primary care less frequently. Conclusions: Smokers prescribed varenicline in primary care in the United Kingdom do not appear to be less likely to die, be hospitalized or experience a myocardial infarction or chronic obstructive pulmonary disease during the following 2 years compared with smokers prescribed nicotine replacement therapy, but they gain more weight and attend primary care less frequently. [ABSTRACT FROM AUTHOR]

Aims To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site ( n = 10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) ( n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% ( n = 48) versus 39.0% [ n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% ( n = 38) versus 28.8% ( n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. [ABSTRACT FROM AUTHOR]

Aims Varenicline was compared with transdermal nicotine (NRT) for smokers with current substance use disorders (SUD) for effects on 3-month smoking abstinence (primary outcome) and, secondarily, on 3- and 6 month abstinence while adjusting for medication adherence, and on additional smoking and substance use outcomes. Moderation by major depressive disorder history (MDD) and adherence were investigated. Design Double-blind double-placebo-controlled randomized design, stratifying by MDD, gender and nicotine dependence, with 3 and 6 months follow-up. Setting University offices in Rhode Island, USA. Participants Adult smokers ( n = 137), in SUD treatment, substance abstinent <12 months ( n = 77 varenicline, 60 NRT). Intervention and comparator Twelve weeks of varenicline (2 mg/day, after 1-week dose run-up) or NRT (21 mg/day decreasing to 7 mg/day). Measurements Primary: point-prevalence smoking abstinence (7-day, confirmed) at 3 months. Secondary: point-prevalence abstinence at 6 months, quantity and frequency of smoking and substance use at 3 and 6 months, and within-treatment abstinence, medication adherence and depressive symptoms. Smoking outcome analyses were repeated controlling for adherence and investigating adherence as a moderator. Findings Effects on 3-month abstinence were P < 0.065 without a covariate (Bayes factor 3.35, supporting the effect strongly) and differed significantly when controlling for baseline smoking [varenicline: 13%, NRT: 3%; odds ratio (OR) = 4.81, 95% confidence interval (CI) 1.00, 23.13, P < 0.05]. The threefold difference at 6 months was not significant. Medication effect on abstinence across time was significant ( P < 0.05) covarying adherence and baseline smoking (OR = 6.40, 95% CI = 1.00, 40.93). Medication differences in 3-month abstinence occurred among participants with ≥ 77% adherence ( P < 0.02). No significant medication effects on heavy drinking, drug use or depressive symptoms were found. Conclusions Varenicline appears to improve the chances of achieving at least 3 months of smoking abstinence in smokers with substance use disorders trying to stop, compared with transdermal nicotine patches, the effect being independent of history of depressive disorder. [ABSTRACT FROM AUTHOR]

Aims Varenicline is used in smoking cessation. The aims of the trial were to test for differences between standard 1- and 0.5-mg doses (both twice daily during 8 weeks) in (1) abstinence, (2) adherence and (3) side effects. Design Open-label randomized parallel-group controlled trial with 1-year follow-up. All those randomized were included in the final sample using an intention-to-treat (ITT) approach. Setting Stop-Smoking Clinic of the Virgen Macarena University Hospital in Seville, Spain. Participants The study comprised smokers ( n = 484), 59.5% of whom were men with a mean age of 50.67 years and a smoking history of 37.5 pack-years. Intervention and comparator Participants were randomized to 1 mg ( n = 245) versus 0.5 mg ( n = 239) and received behavioural support, which consisted of a baseline visit and six follow-ups during 1 year. Measurements The primary outcome was continuous self-reported abstinence during 1 year, with biochemical verification. The secondary outcomes were adherence and side effects. Also measured were baseline demographics, medical history and smoking characteristics. Findings Abstinence rates at 1 year were 46.5% with 1 mg versus 46.4% with 0.5 mg [odds ratio (OR) = 0.997; 95% confidence interval (CI) = 0.7-1.43; P = 1.0]; Bayes factor in favour of H0 = 238.507, Bayes factor against H0 = 0.004. Treatment adherence was similar in both regimens (OR = 1.16; 95% CI = 0.8-1.7; P = 0.44). Side effects were reported in 19.3% of cases with 1 mg versus 12.1% with 0.5 mg, although with no significant differences between regimens (OR = 1.73; 95% CI = 0.94-3.18; P = 0.093). Conclusions There appears to be no difference in smoking cessation effectiveness between 1 mg and 0.5 mg varenicline, both administered twice daily for 8 weeks, with similar rates of abstinence (46.5% versus 46.4%), adherence and side effects. [ABSTRACT FROM AUTHOR]

Aim To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking. Design Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT ( n = 111) or extended CBT ( n = 112) following a 26-week open-label treatment. Setting Community clinic in the United States. Participants A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18). Intervention All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions). Measurements The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat. Findings PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40). Conclusion Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Background and Aims To assess the efficacy and tolerability of adjunctive pharmacotherapy for smoking cessation in adults with serious mental illness (SMI) by means of a systematic review and network meta-analysis. Method We searched Embase, Medline, PsychINFO and the Cochrane Central Register of Controlled Trials from database inception to 1 December 2014 for randomized controlled trials (RCTs) published in English. We included all studies of smokers with SMI (including schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder and depressive psychoses) who were motivated to quit smoking. Pharmacotherapies included nicotine replacement therapy (NRT), bupropion and varenicline delivered as monotherapy or in combination compared with each other or placebo. The efficacy outcome was self-reported sustained smoking cessation, verified biochemically at the longest reported time-point. The tolerability outcome was number of patients discontinuing the trial due to any adverse event. Results Seventeen study reports were included, which represented 14 individual RCTs. No trials were found in patients with depressive psychoses, delusional disorder or that compared NRT monotherapy with placebo. A total of 356 and 423 participants were included in the efficacy and tolerability analyses, respectively. From the network meta-analysis, both bupropion and varenicline were more effective than placebo [odds ratio (OR) = 4.51, 95% credible interval (CrI) = 1.45-14.04 and OR = 5.17, 95% CrI = 1.78-15.06, respectively]. Data were insensitive to an assessment of varenicline versus bupropion (OR = 1.15, 95% CrI = 0.24-5.45). There were no significant differences in tolerability. All outcomes were rated by GRADE criteria as very low quality. Conclusions The limited evidence available to date suggests that bupropion and varenicline are effective and tolerable for smoking cessation in adults with serious mental illnesses. [ABSTRACT FROM AUTHOR]

Aim s To identify promising intervention components intended to help smokers to attain and maintain abstinence in their quit smoking attempts. Design A fully crossed, six-factor randomized fractional factorial experiment. Setting Eleven primary care clinics in southern Wisconsin, USA. Participants A total of 637 adult smokers (55% women, 88% white) motivated to quit smoking who visited primary care clinics. Interventions Six intervention components designed to prepare smokers to quit, and achieve and maintain abstinence (i.e. for the preparation, cessation and maintenance phases of smoking treatment): (1) preparation nicotine patch versus none; (2) preparation nicotine gum versus none; (3) preparation counseling versus none; (4) intensive cessation in-person counseling versus minimal; (5) intensive cessation telephone counseling versus minimal; and (6) 16 versus 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine gum). Measurements Seven-day self-reported point-prevalence abstinence at 16 weeks. Findings Preparation counseling significantly improved week 16 abstinence rates ( P = .04), while both forms of preparation nicotine replacement therapy interacted synergistically with intensive cessation in-person counseling ( P < 0.05). Conversely, intensive cessation phone counseling and intensive cessation in-person counseling interacted antagonistically ( P < 0.05)-these components produced higher abstinence rates by themselves than in combination. Conclusions Preparation counseling and the combination of intensive cessation in-person counseling with preparation nicotine gum or patch are promising intervention components for smoking and should be evaluated as an integrated treatment package. [ABSTRACT FROM AUTHOR]

Background and aims Varenicline increases the likelihood of long-term abstinence following a quit attempt. It has been suggested that (1) part of its benefit arises from 'recruiting into abstinence' smokers who are not able to stop on the target quit date and (2) there may be a higher rate of relapse after treatment. This study addressed these issues. Methods Meta-analyses of data from randomized controlled trials (RCTs) of varenicline identified from the 2012 Cochrane review of nicotine receptor partial agonists for smoking cessation were used to compare the abstinence and relapse patterns on active drug and placebo. Studies of varenicline compared with placebo in adult daily smokers with longest follow-up at either 6 or 12 months and with at least three follow-ups in the first month were included. Biochemically verified abstinence rates at each of six follow-up time-points (2, 3, 4, 12, 24 and 52 weeks) were pooled for studies reporting point prevalence abstinence. Biochemically verified abstinence rates at three follow-up time-periods (9-12 weeks, 9-24 weeks and 9-52 weeks) were pooled for studies reporting continuous abstinence. Random effects meta-analysis was used to estimate pooled proportions with 95% confidence intervals. Results Nineteen RCTs were included. In varenicline-treated participants, point-prevalence abstinence increased by 22 percentage points from week 2 [32%: 95% confidence interval (CI) = 25-40%] to week 12 (54%: 95% CI = 48-61%). The increase was 8 percentage points in the placebo group: 16% (95% CI = 11-21%) to 24% (95% CI = 17-33%). In varenicline-treated participants the relapse from weeks 9-12 to week 52 was 55%: 49% abstinent in weeks 9-12 (95% CI = 45-53%) versus 22% at week 52 (95% CI = 19-25%). In placebo-treated participants it was 53%: 17% (95% CI = 13-25%) in weeks 9-12 versus 8% (95% CI = 6-12%) at week 52. Conclusions Varenicline recruits smokers into abstinence following the target quit date to a greater extent than placebo. Relapse rates from end of treatment to 52 weeks are similar in varenicline- and placebo-treated smokers. [ABSTRACT FROM AUTHOR]

Background and Aims Modelling the population impact and cost-effectiveness of smoking cessation aids is limited by lack of knowledge about how the use of aids changes across quit attempts. Here we test whether the quit method used in a previous attempt influences (i) future decisions to quit and/or (ii) treatment/s used during subsequent attempts. Design and Setting Data came from the Smoking Toolkit Study, a United Kingdom national household survey. Participants and Measures Smokers ( n = 5489) who completed a baseline and 6-month follow-up questionnaire. Respondents were asked what treatment/s, grouped as: prescription medication/s [bupropion, varenicline or nicotine replacement therapy (NRT)], over-the-counter NRT or unaided that they had used in their most recent quit attempt (at baseline), and any use of treatment/s for a quit attempt in the last 3 months at follow-up. Results Smokers who had tried to quit at baseline were more likely to report having tried to quit again prior to follow-up [all odds ratios ≥ 2.19 relative to no attempt at baseline, P < 0.001]. Smokers who tried to quit using pharmacological aids were more likely to try to quit again at follow-up (all ORs ≥ 2.19 relative to no attempt at baseline, P < 0.001). Smokers tended to re-try aids used in baseline attempts in future attempts (all ORs ≥ 1.48 relative to no attempt at baseline, P < 0.01). Conclusions Smokers who have tried to quit in the past year are more likely to try to quit again within 6 months regardless of whether they used a pharmacological aid, and they are more likely to re-try aids they had used previously. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Background and aims There is a need for more evidence on the 'real-world' effectiveness of commonly used aids to smoking cessation from population-level studies. This study assessed the association between abstinence and use of different smoking cessation treatments after adjusting for key potential confounding factors. Design Cross-sectional data from aggregated monthly waves of a household survey: the Smoking Toolkit Study. Setting England. Participants A total of 10 335 adults who smoked within the previous 12 months and had made at least one quit attempt during that time. Measurements Participants were classified according to their use of cessation aids in their most recent quit attempt: (i) medication (nicotine replacement therapy, bupropion or varenicline) in combination with specialist behavioural support delivered by a National Health Service Stop Smoking Service; (ii) medication provided by the prescribing health-care professional without specialist behavioural support; (iii) nicotine replacement therapy ( NRT) bought over the counter; and (iv) none of these. The main outcome measure was self-reported abstinence up to the time of the survey, adjusted for key potential confounders including tobacco dependence. Findings Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the survey were 3.25 [95% confidence interval ( CI) = 2.05-5.15] greater in users of prescription medication in combination with specialist behavioural support, 1.61 (95% CI = 1.33-1.94) greater in users of prescription medication combined with brief advice and 0.96 (95% CI = 0.81-1.13) in users of NRT bought over the counter. Conclusions After adjusting for major confounding variables such as tobacco dependence, smokers in England who use a combination of behavioural support and pharmacotherapy in their quit attempts have almost three times the odds of success than those who use neither pharmacotherapy nor behavioural support. Smokers who buy nicotine replacement therapy over the counter with no behavioural support have similar odds of success in stopping as those who stop without any aid. [ABSTRACT FROM AUTHOR]

Aim To evaluate the population effectiveness of stop-smoking medications while accounting for potential recall bias by controlling for quit attempt recency. Design Prospective cohort survey. Setting United Kingdom, Canada, Australia and the United States. Participants A total of 7436 adult smokers (18+ years) selected via random digit dialling and interviewed as part of the International Tobacco Control Four Country Survey ( ITC-4) between 2002 and 2009. Primary analyses utilized the subset of respondents who participated in 2006 or later ( n = 2550). Measurements Continuous abstinence from smoking for 1 month/6 months. Findings Among participants who recalled making a quit attempt within 1 month of interview, those who reported using varenicline, bupropion or nicotine patch were more likely to maintain 6-month continuous abstinence from smoking compared to those who attempted to quit without medication [adjusted odds ratio ( OR) 5.84, 95% confidence interval ( CI) (2.12-16.12), 3.94 (0.87-17.80), 4.09 (1.72-9.74), respectively]; there were no clear effects for oral NRT use. Those who did not use any medication when attempting to quit tended to be younger, to be racial/ethnic minorities, to have lower incomes and to believe that medications do not make quitting easier. Conclusions Consistent with evidence from randomized controlled trials, smokers in the United Kingdom, Canada, Australia and the United States are more likely to succeed in quit attempts if they use varenicline, bupropion or nicotine patch. Previous population studies that failed to find an effect failed to control adequately for important sources of bias. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To examine the association of person-specific trajectories of withdrawal symptoms of urge-to-smoke, negative affect, physical symptoms and hunger during the first 7 days after smoking cessation with abstinence at end of treatment (EOT) and at 6 months. Design Hierarchical linear modeling (HLM) was used to model person-specific trajectory parameters (level, slope, curvature and volatility) for withdrawal symptoms. Setting University-based smoking cessation trials. Participants Treatment-seeking smokers in clinical trials of transdermal nicotine versus nicotine spray ( n = 514) and bupropion versus placebo ( n = 421). Measurements Self-reported withdrawal symptoms for 7 days after the planned quit date, and 7-day point prevalence and continuous abstinence at EOT and 6 months. Findings In regressions that included trajectory parameters for one group of withdrawal symptoms, both urge-to-smoke and negative affect were predictive of abstinence while physical symptoms and hunger were generally not predictive. In stepwise regressions that included the complete set of trajectory parameters across withdrawal symptoms (for urge-to-smoke, negative affect, physical symptoms and hunger), with a single exception only the trajectory parameters for urge-to-smoke were predictive. Area under the receiver operator characteristic curve was 0.594 for covariates alone, and 0.670 for covariates plus urge-to-smoke trajectory parameters. Conclusions Among a number of different withdrawal symptoms (urge-to-smoke, negative affect, physical symptoms and hunger) urge-to-smoke trajectory parameters (level, slope and volatility) over the first 7 days of smoking cessation show the strongest prediction of both short- and long-term relapse. Other withdrawal symptoms increase the predictive ability by negligible amounts. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study aimed to assess the effects of opportunistic brief physician advice to stop smoking and offer of assistance on incidence of attempts to stop and quit success in smokers not selected by motivation to quit. Methods We included relevant trials from the Cochrane Reviews of physician advice for smoking cessation, nicotine replacement therapy (NRT), varenicline and bupropion. We extracted data on quit attempts and quit success. Estimates were combined using the Mantel-Haentszel method and heterogeneity assessed with the I2 statistic. Study quality was assessed by method of randomization, allocation concealment and follow-up blind to allocation. Results Thirteen studies were included. Compared to no intervention, advice to quit on medical grounds increased the frequency of quit attempts [risk ratio (RR) 1.24, 95% confidence interval (CI): 1.16-1.33], but not as much as behavioural support for cessation (RR 2.17, 95% CI 1.52-3.11) or offering NRT (RR 1.68, 95% CI: 1.48-1.89). In a direct comparison, offering assistance generated more quit attempts than giving advice to quit on medical grounds (RR 1.69, 95% CI: 1.24-2.31 for behavioural support and 1.39, 95% CI: 1.25-1.54 for offering medication). There was evidence that medical advice increased the success of quit attempts and inconclusive evidence that offering assistance increased their success. Conclusions Physicians may be more effective in promoting attempts to stop smoking by offering assistance to all smokers than by advising smokers to quit and offering assistance only to those who express an interest in doing so. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smoking cessation trials generally record information on daily smoking behavior, but base analyses on measures of smoking status at the end of treatment (EOT). We present an alternative approach that analyzes the entire sequence of daily smoking status observations. Methods We analyzed daily abstinence data from a smoking cessation trial, using two longitudinal logistic regression methods: a mixed-effects (ME) model and a generalized estimating equations (GEE) model. We compared results to a standard analysis that takes abstinence status at EOT as outcome. We evaluated time-varying covariates (smoking history and time-varying drug effect) in the longitudinal analysis and compared ME and GEE approaches. Results We observed some differences in the estimated treatment effect odds ratios across models, with narrower confidence intervals under the longitudinal models. GEE yields similar results to ME when only baseline factors appear in the model, but gives biased results when one includes time-varying covariates. The longitudinal models indicate that the quit probability declines and the drug effect varies over time. Both the previous day's smoking status and recent smoking history predict quit probability, independently of the drug effect. Conclusion When analysing outcomes of studies from smoking cessation interventions, longitudinal models with multiple outcome data points, rather than just end of treatment, can makes efficient use of the data and incorporate time-varying covariates. The generalized estimating equations approach should be avoided when using time-varying predictors. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To examine person-specific urge-to-smoke trajectories during the first 7 days of abstinence and the relationship of trajectory parameters to continuous abstinence, demographics, medication and smoking history. Design Hierarchical linear modeling was used to model person-specific trajectories for urge-to-smoke. Setting Two university-based smoking cessation trials. Participants Treatment-seeking smokers in a clinical trial of transdermal nicotine ( n = 275) versus nicotine spray ( n = 239) and of bupropion ( n = 223) versus placebo ( n = 198). Measurements Self-reported urge-to-smoke for 7 days after the planned quit date, and 7-day point prevalence and continuous abstinence at end of treatment (EOT) and 6 months. Findings Urge-to-smoke trajectory parameters (average level, slope, curvature and volatility) varied substantially among individuals, had modest intercorrelations and predicted continuous and point prevalence abstinence at EOT and at 6 months. Higher trajectory level, slope and volatility were all significantly ( P ≤ 0.001) associated with a reduced likelihood of abstinence at EOT (odds ratios 0.44-0.75) and at 6-month follow-up (odds ratios from 0.63 to 0.78), controlling for demographic, medication and smoking use variables. Conclusion Higher urge-to-smoke trajectory parameters of level, slope and volatility (measured over 7 days) predict continuous and 7-day point prevalence at EOT and 6 months. Although there were some associations of trajectory parameters with demographics and smoking history, the associations of trajectory parameters with relapse were relatively uninfluenced by demographics and smoking history. [ABSTRACT FROM AUTHOR]

Despite the many similarities between nicotine dependence and other drug dependences, national guidelines for their treatment differ in several respects. The recent national guideline for the treatment of nicotine dependence has (i) less emphasis on detailed assessment; (ii) less emphasis on treatment of psychiatric comorbidity; (iii) less acceptance of reduction of use as an initial treatment goal; (iv) greater emphasis on pharmacological interventions; and (v) less emphasis on psychosocial treatment than national guidelines for non-nicotine dependences. These treatment differences may occur because (i) nicotine does not cause behavioral intoxication; (ii) psychiatric comorbidity is less problematic with nicotine dependence; (iii) psychosocial problems are less severe with nicotine dependence; and (iv) available pharmacotherapies for nicotine dependence are safer, more numerous and more easily available. However, it is unclear whether these treatment differences are, in fact, justifiable because of the scarcity of empirical tests. We suggest several possible empirical tests. [ABSTRACT FROM AUTHOR]

Aim Nicotine replacement therapy (NRT) is effective for smoking cessation, but most smokers try to quit without using it. We examined the impact of misperceptions of NRT safety and efficacy on its use. Design and participants A total of 3203 current and former US smokers completed a national mail-out survey of issues and attitudes related to smoking cessation. Findings Two-thirds (66%) of respondents either agreed that ‘Stop-smoking products with nicotine are just as harmful as cigarettes’ or were unsure whether the statement was true. These respondents were less likely to have used NRT in the past [30% versus 49%; odds ratio (OR) = 0.45, 95% confidence interval (CI): 0.39–0.53] and less likely to consider using NRT during future quit attempts (40% versus 53%; OR = 0.60, 95% CI = 0.51–0.71). Additionally, of the respondents who had used nicotine gum in the past 12 months ( n = 407), those who had concerns about the safety of NRT reported using fewer pieces of gum per day during treatment (six versus eight pieces/day; P < 0.05), and were less likely to report that they used the gum for greater than 4 weeks (28.5% versus 46.8%; OR = 0.45, 95% CI: 0.27–0.76). A large proportion of the respondents also stated that they did not believe NRT to be efficacious. Conclusions The findings suggest that many smokers are misinformed about the health risks of NRT and that these misperceptions impede not only the adoption of NRT but also compliance during treatment. Misperception of NRT safety is one barrier to effective use of NRT and probably reduces success in quitting. [ABSTRACT FROM AUTHOR]

Primary aim Examine the effectiveness of extended cognitive behavior therapy (CBT) in promoting longer-term smoking abstinence. Design Open-label treatment phase followed by extended treatment phase. Randomization conducted prior to entry into open-label treatment phase; analysis based on intention-to-treat to avoid threat of selection bias. Setting Community smoking cessation clinic. Participants A total of 304 adult smokers (≥18 years of age; ≥10 cigarettes/day). Intervention Open-label (8 weeks): all participants received bupropion SR, nicotine patch, CBT. Extended treatment (12 weeks): participants received either CBT + voicemail monitoring and telephone counseling or telephone-based general support. Measurements Seven-day point prevalence abstinence, expired-air carbon monoxide. Results At week 20 follow-up, CBT produced a higher 7-day point prevalence abstinence rate: 45% versus 29%, P = 0.006; at 52 weeks the difference in abstinence rates (31% versus 27%) was not significant. History of depression was a moderator of treatment. Those with a positive history had a better treatment response at 20 weeks when assigned to the less intensive telephone support therapy ( P < 0.05). Conclusion The superiority of CBT to 20 weeks suggests that continued emphasis on the development of cognitive and behavioral strategies for maintaining non-smoking during an extended treatment phase may help smokers to maintain abstinence in the longer term. At present, the minimum duration of therapy is unknown. [ABSTRACT FROM AUTHOR]

Aim To evaluate the incremental efficacy of starting nicotine patch treatment prior to quitting compared to the current regimen of starting patch treatment on the target quit day. Design and measurements Meta-analysis of four eligible studies using pre-cessation patch treatment, located by database search and contacts with cessation researchers. The studies all compared starting treatment with nicotine patch prior to the target quit date to starting active treatment at the quit date, some in the context of concurrent mecamylamine treatment. The primary end-point for the analysis was continuous abstinence for at least 28 days assessed at 6 weeks following quit day; 6-month outcomes were also examined. Findings Compared to starting active patch treatment on quit day, pre-cessation treatment with nicotine patches was found to double the odds of quitting. This was true both at 6 weeks [pooled odds ratio (OR) = 1.96, 95% confidence interval (CI): 1.31–2.93] and 6 months (pooled OR = 2.17, 95% CI: 1.46–3.22) treatment outcomes. Mecamylamine co-treatment did not modify these effects. Conclusions Across the four studies analyzed, pre-cessation patch treatment was found to produce a robust increase in quit rates compared to current regimens starting patch at quit day. Pre-cessation patch use represents a promising innovation in smoking cessation therapy with potential beneficial implications for improved public health by further increasing quitting success. [ABSTRACT FROM AUTHOR]