Internet-based intervention for smoking cessation (StopAdvisor) in people with low and high socioeconomic status: a randomised controlled trial.

BACKGROUND: Internet-based interventions for smoking cessation could help millions of people stop smoking at very low unit costs; however, long-term biochemically verified evidence is scarce and such interventions might be less effective for smokers with low socioeconomic status than for those with high status because of lower online literacy to engage with websites. We aimed to assess a new interactive internet-based intervention (StopAdvisor) for smoking cessation that was designed with particular attention directed to people with low socioeconomic status. METHODS: We did this online randomised controlled trial between Dec 6, 2011, and Oct 11, 2013, in the UK. Participants aged 18 years and older who smoked every day were randomly assigned (1:1) to receive treatment with StopAdvisor or an information-only website. Randomisation was automated with an unseen random number function embedded in the website to establish which treatment was revealed after the online baseline assessment. Recruitment continued until the required sample size had been achieved from both high and low socioeconomic status subpopulations. Participants, and researchers who obtained data and did laboratory analyses, were masked to treatment allocation. The primary outcome was 6 month sustained, biochemically verified abstinence. The main secondary outcome was 6 month, 7 day biochemically verified point prevalence. Analysis was by intention to treat. Homogeneity of intervention effect across the socioeconomic subsamples was first assessed to establish whether overall or separate subsample analyses were appropriate. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN99820519. FINDINGS: We randomly assigned 4613 participants to the StopAdvisor group (n=2321) or the control group (n=2292); 2142 participants were of low socioeconomic status and 2471 participants were of high status. The overall rate of smoking cessation was similar between participants in the StopAdvisor and control groups for the primary (237 [10%] vs 220 [10%] participants; relative risk [RR] 1·06, 95% CI 0·89-1·27; p=0·49) and the secondary (358 [15%] vs 332 [15%] participants; 1·06, 0·93-1·22; p=0·37) outcomes; however, the intervention effect differed across socioeconomic status subsamples (1·44, 0·99-2·09; p=0·0562 and 1·37, 1·02-1·84; p=0·0360, respectively). StopAdvisor helped participants with low socioeconomic status stop smoking compared with the information-only website (primary outcome: 90 [8%] of 1088 vs 64 [6%] of 1054 participants; RR 1·36, 95% CI 1·00-1·86; p=0·0499; secondary outcome: 136 [13%] vs 100 [10%] participants; 1·32, 1·03-1·68, p=0·0267), but did not improve cessation rates in those with high socioeconomic status (147 [12%] of 1233 vs 156 [13%] of 1238 participants; 0·95, 0·77-1·17; p=0·61 and 222 [18%] vs 232 [19%] participants; 0·96, 0·81-1·13, p=0·64, respectively). INTERPRETATION: StopAdvisor was more effective than an information-only website in smokers of low, but not high, socioeconomic status. StopAdvisor could be implemented easily and made freely available, which would probably improve the success rates of smokers with low socioeconomic status who are seeking online support. FUNDING: National Prevention Research Initiative.

Comparison of the effectiveness of varenicline and combination nicotine replacement therapy for smoking cessation in clinical practice.

OBJECTIVE: To compare the effectiveness of varenicline and combination nicotine replacement therapy (NRT) for treating smokers attempting to stop, as it is unclear which of the 2 is more effective. PATIENTS AND METHODS: Data from 167,487 treatment episodes in patients from 42 National Health Service Stop Smoking Services (April 1, 2009, through June 30, 2011) using varenicline or combination NRT were analyzed. The outcome was carbon monoxide-validated 4-week smoking abstinence. Potential predictors were age, sex, occupational grade, exemption from prescription charges, intervention setting (specialist or other), support (group or other), and year of quit attempt. RESULTS: Observed smoking abstinence rates were higher with varenicline (43.5% vs 36.9%). However, there was evidence of systematic variation in medication effect across clinical services and differences in predictors of outcome between medications. Allowing for these influences indicated a small mean advantage for varenicline (odds ratio, 1.080; 95% CI, 1.003-1.163; difference, 1.86%; 95% CI, 0.07%-3.67%; P=.04). The relative effectiveness of the 2 medications was not moderated by setting, type of support, or year. CONCLUSION: The relative effect of medication varies substantially according to clinical practice and population treated. Averaged across current English clinical practice and populations, varenicline is marginally more effective than combination NRT. Demographic and intervention characteristics associated with success predict varenicline use.

A pilot study of StopAdvisor: a theory-based interactive internet-based smoking cessation intervention aimed across the social spectrum.

BACKGROUND: This article reports a pilot study of a new smoking cessation website ('StopAdvisor'), which has been developed on the basis of PRIME theory, evidence, web-design expertise and user-testing. The aims were to i) evaluate whether cessation, website usage and satisfaction were sufficiently high to warrant a randomised controlled trial (RCT) and ii) assess whether outcomes were affected by socio-economic status. METHODS: This was an uncontrolled pilot study. Two hundred and four adult daily smokers willing to make a serious quit attempt were included. All participants received support from 'StopAdvisor', which recommends a structured quit plan and a variety of evidence-based behaviour change techniques for smoking cessation. A series of tunnelled sessions and a variety of interactive menus provide tailored support for up to a month before quitting through until one-month post-quit (http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The primary outcome was self-report of at least 1month of continuous abstinence collected at 2months post-enrolment and verified by saliva cotinine or anabasine. Usage was indexed by log-ins and page views. Satisfaction was assessed by dichotomous ratings of helpfulness, personal relevance, likelihood of recommendation and future use, which were collected using an online questionnaire at 2months post-enrolment. Outcomes according to socio-economic status were assessed. RESULTS: At 8weeks post-enrolment, 19.6% (40/204) of participants were abstinent according to the primary outcome criteria (95% C.I.=14.1% to 25.1%). Participants viewed a mean of 133.5 pages (median=71.5) during 6.4 log-ins (median=3). A majority of respondents rated the website positively on each of the four satisfaction `ratings (range=66.7% to 75.3%). There was no evidence of an effect of socio-economic status on abstinence (OR=1.01, C.I.=0.50-2.07), usage (page-views, t(202)=0.11, p=.91; log-ins, t(202)=0.21, p=.83), or satisfaction (helpfulness, OR=1.09, C.I.=0.41-2.88; personal relevance, OR=0.55, C.I.=0.20-1.56; recommendation, OR=0.98, C.I.=0.34-2.81; use in future, OR=1.45, C.I.=0.49-4.27). CONCLUSIONS: The systematic application of theory, evidence, web-design expertise, and user-testing has resulted in a website that shows sufficiently promising efficacy and usability to warrant evaluation in a RCT. The website appears to be similarly effective and acceptable to users across the social spectrum.

A direct method and ICER tables for the estimation of the cost-effectiveness of smoking cessation interventions in general populations: application to a new cytisine trial and other examples.

INTRODUCTION: The popularity of smoking cost-effectiveness (CE) analysis has grown rapidly. Differences in models and inputs mean results may not be comparable, and researchers may have to take them on trust because the methods are beyond their expertise and not always transparent. We describe a direct method and tables of results for researchers without specialist knowledge. METHODS: We estimate the health benefit to an individual attributed to an intervention and compute tables of incremental cost-effectiveness ratios (ICERs) for interventions with varying incremental intervention effects and costs. Estimates of life years gained come from the longest epidemiological study. After discounting, adjustments are made for future cessation and relapse. The method is described in simple steps, and conservative inputs are used throughout. RESULTS: To look up an ICER, the user needs only to know the cost of the intervention per smoker and the effect as measured by the percentage of ex-smokers attributable to the intervention at either 6- or 12-month follow-up. Reanalysis of authoritative reports indicates that these ICERs are comparable to those from decision-analytic simulation models. CONCLUSIONS: Researchers can now obtain immediate estimates of the CE of interventions in general populations. The method is easily programmed in a spreadsheet. ICERs are from the payer perspective and exclude offset and societal costs. Interventions in subpopulations will require inputs specific to those populations. Readers who wish to include an adjustment for quality of life can easily do so. The tables might promote a standard approach, with interventions compared on a consistent and transparent basis.

Development of StopAdvisor: A theory-based interactive internet-based smoking cessation intervention.

Reviews of internet-based behaviour-change interventions have shown that they can be effective but there is considerable heterogeneity and effect sizes are generally small. In order to advance science and technology in this area, it is essential to be able to build on principles and evidence of behaviour change in an incremental manner. We report the development of an interactive smoking cessation website, StopAdvisor, designed to be attractive and effective across the social spectrum. It was informed by a broad motivational theory (PRIME), empirical evidence, web-design expertise, and user-testing. The intervention was developed using an open-source web-development platform, 'LifeGuide', designed to facilitate optimisation and collaboration. We identified 19 theoretical propositions, 33 evidence- or theory-based behaviour change techniques, 26 web-design principles and nine principles from user-testing. These were synthesised to create the website, 'StopAdvisor' (see http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The systematic and transparent application of theory, evidence, web-design expertise and user-testing within an open-source development platform can provide a basis for multi-phase optimisation contributing to an 'incremental technology' of behaviour change.

'The smoking toolkit study': a national study of smoking and smoking cessation in England.

BACKGROUND: Up-to-date data tracking of national smoking patterns and cessation-related behaviour is required to evaluate and inform tobacco control strategies. The Smoking Toolkit Study (STS) was designed for this role. This paper describes the methodology of the STS and examines as far as possible the representativeness of the samples. METHODS: The STS consists of monthly, cross sectional household interviews of adults aged 16 and over in England with smokers and recent ex-smokers in each monthly wave followed up by postal questionnaires three and six months later. Between November 2006 and December 2010 the baseline survey was completed by 90,568 participants. STS demographic, prevalence and cigarette consumption estimates are compared with those from the Health Survey for England (HSE) and the General Lifestyle Survey (GLF) for 2007-2009. RESULTS: Smoking prevalence estimates of all the surveys were similar from 2008 onwards (e.g 2008 STS=22.0%, 95% C.I.=21.4% to 22.6%, HSE=21.7%, 95% C.I.=20.9% to 22.6%, GLF=20.8%, 95% C.I.=19.7% to 21.9%), although there was heterogeneity in 2007 (chi-square=50.30, p<0.001). Some differences were observed across surveys within sociodemographic sub-groups, although largely in 2007. Cigarette consumption was virtually identical in all surveys and years. CONCLUSION: There is reason to believe that the STS findings (see http://www.smokinginengland.info) are generalisable to the adult population of England.

Variation in saliva cotinine as a function of self-reported attempts to reduce cigarette consumption.

RATIONALE: Cotinine is an accurate objective marker of nicotine intake. There is very little information on its stability over time or as a function of self-reported attempts at smoking reduction. OBJECTIVES: This study aimed to assess the stability of saliva cotinine concentrations over a 3-month period, as a function of self-reported attempts to reduce cigarette consumption, using data from a general population sample of English smokers. METHODS: Six-hundred and ninety-one smokers from a population sample of English smokers provided saliva samples for cotinine analysis on two occasions 3 months apart. Data on cigarette consumption, whether smokers reported that they were attempting to cut down consumption and concurrent use of nicotine replacement therapy (NRT), were also collected on both occasions. RESULTS: The 'test-retest' measure of cotinine stability was 0.76, and the simple correlation was 0.73. Smokers not using NRT who reported cutting down on one occasion but not the other showed a small reduction in cigarette consumption at the time they were cutting down (1.1 cig per day, p = 0.013) but no significant difference in saliva cotinine concentrations (mean reduction = 13.4 ng/ml, p = 0.39). CONCLUSIONS: Saliva cotinine concentrations show moderate-to-high stability within subjects over a 3-month period. Smokers' reports of attempting to cut down their smoking are associated with small daily cigarette consumption decreases but no detectable change in nicotine intake.

Treating heavy smokers in primary care with the nicotine nasal spray: randomized placebo-controlled trial.

AIMS: Of six established nicotine replacement therapy (NRT) formulations, only the gum and patch have been tested without specialist clinic support in placebo-controlled trials. We aimed to broaden the evidence base by examining if the nicotine nasal spray (NNS) could be effective with only brief support in general practice. DESIGN: Randomized placebo-controlled trial. SETTING: Twenty-seven English general practices. PARTICIPANTS: A total of 761 heavy smokers received brief support and 12 weeks of treatment with NNS (506) or placebo (255). MEASUREMENTS: The primary outcome was biochemically verified complete abstinence from smoking throughout weeks 3-12. FINDINGS: NNS compared with placebo more than doubled the number who successfully stopped smoking [15.4% versus 6.7%, odds ratio (OR) = 2.6, 95% confidence interval (CI) = 1.5-4.4]. Many participants reported minor irritant adverse symptoms. NNS was particularly effective among those who were more highly dependent on nicotine (OR = 6.17, 95% CI = 2.13-17.9). Of those who failed to stop during the first week (417, 54.8%), only one (0.2%) achieved later success. CONCLUSIONS: NNS is effective when given in primary care. The benefit was lower than in a specialist clinic but similar to that with the nicotine patch in primary care. Unlike most other NRT formulations, bupropion or varenicline, NNS was especially helpful for more dependent smokers. Continuing treatment of those initially failing was not beneficial. An initial 1-week prescription to those more dependent on nicotine is likely to be the most cost-effective NNS treatment protocol. These results should offer support to the effectiveness of the other NRT formulations untested in this setting.

Illicit drug use as a predictor of smoking cessation treatment outcome.

INTRODUCTION: Evidence from cross-sectional survey data suggests a negative association between illicit drug use and smoking cessation. In a prospective clinical cohort, we examined whether illicit drug users were less successful than other smokers when making an attempt to stop smoking. METHODS: A total of 100 smokers attending a tobacco dependence clinic were studied. Pretreatment questionnaire measures of illicit drug use, demographics, health history, and tobacco smoking were taken. Treatment consisted of seven weekly behavioral support sessions plus nicotine replacement therapy or bupropion. Short-term outcome was assessed at the end of the treatment by self-report and carbon monoxide (CO) verification. RESULTS: A total of 24 smokers (24%) had used illicit drugs during the previous 30 days. Drug users were less likely to stop smoking than were nonusers. The difference in CO-verified success rates was 26.1% (29.2% vs. 55.3%, 95% CI = 4.8%-47.4%), and the odds ratio was 0.33 (95% CI = 0.12-0.89). Adjustment for group differences on all the measured background and treatment characteristics affected this result only marginally. DISCUSSION: Illicit drug use appears to have a significant detrimental effect on the success of an attempt to stop smoking. This effect is not explained by differences between drug users and nonusers on established prognostic factors. These first results in a prospective sample support findings from a large U.S. population survey of smoking cessation rates in drug users and nonusers. If these results are corroborated, clinicians treating smokers should consider developing new protocols to improve outcomes in smokers using illicit drugs.

Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness.

AIMS: To compare the effectiveness of varenicline with nicotine replacement for smoking cessation and to evaluate the safety and effectiveness of varenicline in people with mental illness. DESIGN: Evaluation of consecutive routine cases before and after the introduction of varenicline. SETTING: National Health Service (NHS) tobacco dependence clinic in London, UK. PARTICIPANTS: A total of 412 cases receiving routine care. INTERVENTION: Seven group support sessions over 6 weeks with either nicotine replacement therapy (NRT) (n = 204) or varenicline (n = 208). MEASUREMENTS: Verified abstinence 4 weeks after quit day, severity of withdrawal symptoms, incidence and severity of adverse drug symptoms, cost per patient treated and cost per successful short-term quitter. FINDINGS: Short-term cessation rates were higher with varenicline than NRT (odds ratio = 1.70, 95% confidence interval = 1.09-2.67). Varenicline was equally effective in those with and without mental illness. Craving to smoke, but not adverse mood, was less severe with varenicline than NRT. The cost per quitter was similar for varenicline and NRT. There was a higher incidence of adverse drug symptoms among those taking varenicline, but these were tolerated by most smokers. There was no evidence that varenicline exacerbated mental illness. CONCLUSIONS: In this setting and with group support varenicline appears to improve success rates over those achieved with NRT, and is equally effective and safe in those with and without a mental illness.

Association between dopamine transporter genotypes and smoking cessation: a meta-analysis.

This review assessed the evidence of an association between genotypes of the dopamine transporter (DAT1, SLC6A3) 3' untranslated region (3'UTR) variable number of tandem repeats (VNTR) and smoking cessation. Five studies (seven cohorts) comprising 2155 subjects were included in the meta-analysis. All gave data on the number of smokers who had stopped smoking and the number still smoking for those with one or more variant 9-repeat alleles and other genotypes. Three studies (comprising five cohorts) were cross-sectional population surveys and two were smoking cessation treatment programs with follow-up. Four of the five studies (six of the seven cohorts) showed a trend in favor of cessation when the variant 9-repeat allele was present, although only one study showed a statistically significant effect. The pooled odds ratio in favor of a greater likelihood of cessation for the variant 9-repeat allele was 1.15 [95% confidence interval (CI) = 0.97-1.37]. In a more refined analysis where cohorts within studies were treated as separate samples and adjusted odds ratios were used, the overall pooled odds ratio in favor of cessation with the 9-repeat alleles was 1.20 (95% CI = 1.01-1.43). These results support the hypothesis that the DAT1 3'UTR VNTR polymorphism is associated with smoking cessation. One or more variant 9-repeat alleles relative to the more common 10-repeat allele confers a greater likelihood of cessation, indicative of lower dependence on tobacco. The effect was a 20% increase in the odds of cessation for those with a variant allele.

Nicotine replacement therapy for long-term smoking cessation: a meta-analysis.

OBJECTIVE: To assess if the effect of a single treatment episode with nicotine replacement therapy (NRT) enhances smoking cessation over many years. DATA SOURCES: Meta-analysis of all randomised controlled trials of NRT with final follow-up more than one year after the start of treatment. Twelve eligible trials were identified, all placebo-controlled, having final follow-ups ranging from 2-8 years. All had earlier follow-ups at 12 months. They comprised 2408 active and 2384 placebo treatment participants. DATA SYNTHESIS: The odds ratio (OR) in favour of NRT at final follow-up was 1.99 (95% confidence interval (CI) 1.50 to 2.64). There was no evidence that the effect varied according to length of final follow-up (beta = 0.92, p = 0.28) or duration of initial NRT treatment (beta = 0.99, p > 0.5). The overall relapse rate between the 12 months and final follow-up was 30.0% (95% CI 23.5% to 37.5%). This rate did not differ between NRT and control groups (OR 1.11, 95% CI 0.78 to 1.59), or length of initial NRT treatment. There was also no evidence that it varied according to length of final follow up. Due to relapse, the overall efficacy of NRT treatment in terms of additional ex-smokers declined from 10.7% over and above placebo (6.6% to 14.8%) after one year to 7.2% (3.8% to 11.3%) at an average of 4.3 years follow up. CONCLUSIONS: The relative efficacy of a single course of NRT remains constant over many years. The majority of relapse after 12 months occurs within the first or second year and is not detectable thereafter, suggesting that NRT has a permanent effect on smoking cessation. However, initial relapse after one year has the effect of diminishing the number of ex-smokers that can be ultimately attributed to NRT. Results after only 6-12 months of follow-up, as used in existing reviews and treatment guidelines, will overestimate the lifetime benefit and cost-efficacy of NRT by about 30%. Because the long-term benefit of NRT is modest, tobacco dependence treatment might be better viewed as a chronic disorder, requiring repeated episodes of treatment.