Reducing tobacco use in substance use treatment: The California tobacco free initiative.

BACKGROUND: People in substance use disorder (SUD) treatment have a smoking prevalence that is five times higher than the national average. California funded the Tobacco Free for Recovery Initiative, designed to support programs in implementing tobacco-free grounds and increasing smoking cessation services. In the first cohort of the initiative (2018-2020) client smoking prevalence decreased from 54.2% to 26.6%. The current study examined whether similar findings would be replicated with a later cohort of programs (2020-2022). METHOD: Cross-sectional survey data were collected from clients in 11 residential SUD treatment programs at baseline (n = 185) and at post intervention (n = 227). Multivariate logistic regression assessed change over time in smoking prevalence, tobacco use behaviors, and receipt of cessation services across the two timepoints. RESULTS: Client smoking prevalence decreased from 60.3 % to 40.5 % (Adjusted Odds Ratio [AOR] = 0.46, 95 % CI = 0.27, 0.78; p = 0.004). Current smokers and those who quit while in treatment reported an increase in nicotine replacement therapy (NRT)/pharmacotherapy from baseline to post intervention (31.9 % vs 45.6 %; AOR = 2.22, 95 % CI = 1.08, 4.58; p = 0.031). CONCLUSIONS: Like the first cohort, the Tobacco Free for Recovery initiative was associated with decreased client smoking prevalence and an increase in NRT/pharmacotherapy. These findings strengthen the evidence that similar initiatives may be effective in reducing smoking prevalence among people in SUD treatment.

Receipt of and Spending on Cessation Medication Among US Adults With Employer-Sponsored Health Insurance, 2010 and 2017.

OBJECTIVE: Studies examining the use of smoking cessation treatment and related spending among enrollees with employer-sponsored health insurance are dated and limited in scope. We assessed changes in annual receipt of and spending on cessation medications approved by the US Food and Drug Administration (FDA) among tobacco users with employer-sponsored health insurance from 2010 to 2017. METHODS: We analyzed data on 439 865 adult tobacco users in 2010 and 344 567 adult tobacco users in 2017 from the IBM MarketScan Commercial Database. We used a negative binomial regression to estimate changes in receipt of cessation medication (number of fills and refills and days of supply). We used a generalized linear model to estimate spending (total, employers', and out of pocket). In both models, covariates included year, age, sex, residence, and type of health insurance plan. RESULTS: From 2010 to 2017, the percentage of adult tobacco users with employer-sponsored health insurance who received any cessation medication increased by 2.4%, from 15.7% to 16.1% (P < .001). Annual average number of fills and refills per user increased by 15.1%, from 2.5 to 2.9 (P < .001) and days of supply increased by 26.4%, from 81.9 to 103.5 (P < .001). The total annual average spending per user increased by 53.6%, from $286.40 to $440.00 (P < .001). Annual average out-of-pocket spending per user decreased by 70.9%, from $70.80 to $20.60 (P < .001). CONCLUSIONS: Use of smoking cessation medications is low among smokers covered by employer-sponsored health insurance. Opportunities exist to further increase the use of cessation medications by promoting the use of evidence-based cessation treatments and reducing barriers to coverage, including out-of-pocket costs.

American Indian/Alaska Native Smokers' Utilization of a Statewide Tobacco Quitline: Engagement and Quitting Behaviors From 2008 to 2018.

INTRODUCTION: The objective of this study was to examine access, engagement, and quitting behaviors of American Indian/Alaska Native (AIAN) callers to the California Smokers' Helpline. Telephone counseling is the primary function of the quitline. The overarching theoretical framework for California's quitline is social cognitive theory, although it also utilizes motivational interviewing and cognitive-behavioral strategies. AIMS AND METHODS: AIAN (n = 16 089) and White (n = 173 425) California quitline callers from 2009 to 2018 were compared on their characteristics, engagement, and quitting behaviors. Quitline callers responded to a telephone survey at intake. A random selection was called for evaluation 7 months later (White n = 8194, AIAN n = 764). Data from the 2009 to 2017 California Health Interview Survey (CHIS) were used as a reference point for AIANs (AIAN n = 1373). RESULTS: The quitline and CHIS had similar proportions of AIANs (4.6% vs. 4.3%, respectively). AIAN smokers were more likely than White smokers to report physical (53.6% vs. 44.9%) and mental (65.7% vs. 57.8%) health conditions at intake. AIANs were more likely to participate in counseling than White callers (67.1% vs. 65.7%). Among those who received counseling, AIANs had greater odds than White smokers of making a quit attempt (adjusted odds ratio = 1.39 [1.06, 1.81]) and similar odds of quitting for 180 days (adjusted odds ratio = 0.95 [0.69, 1.31]). CONCLUSIONS: Rates of access, engagement, and quitting suggest that individualized quitline counseling was as effective with AIANs as it was with White smokers. Increasing efforts to refer AIANs to existing state quitlines can help more smokers quit. IMPLICATIONS: This study showed that AIAN smokers were well represented among California quitline callers, even without a targeted campaign. It also found that AIAN smokers engaged in quitline services and were as able to quit as their White counterparts were, even after adjusting for other baseline characteristics. One implication is that public health programs can promote quitlines using broad-based campaigns knowing that they will still motivate AIAN smokers to seek help. Another implication is that a standard, individualized counseling protocol delivered by culturally competent quitline staff can effectively help AIAN smokers to quit.

How Financial Incentives Increase Smoking Cessation: A Two-Level Path Analysis.

INTRODUCTION: Financial incentives effectively increase smoking cessation rates, but it is unclear via which psychological mechanisms incentives influence quit behavior. The current study examines how receiving financial incentives for smoking cessation leads to quitting smoking and investigates several mediators and moderators of that relationship. AIMS AND METHODS: The study sample consisted of 604 tobacco-smoking employees from 61 companies in the Netherlands who completed a baseline and follow-up questionnaire. The current study is a secondary analysis from a cluster randomized trial where employees received smoking cessation group counseling at the workplace. Participants in the intervention group additionally received financial incentives of €350 in total for 12-month continuous smoking abstinence. We used a two-level path analysis to test a model that assesses the effects of financial incentives through smoking cessation program evaluation, medication use, nicotine replacement use, attitudes, self-efficacy, and social influences on quit success. We additionally tested whether an individual's reward responsiveness moderated the influence of incentives on quit success. RESULTS: The effect of financial incentives on quit success was mediated by a higher self-efficacy. Financial incentives were also associated with a higher use of cessation medication. A more positive program evaluation was related to higher self-efficacy, more social influence to quit, and more positive attitudes about quitting. The results did not differ significantly by individual reward responsiveness. CONCLUSIONS: The results of the current study suggest that financial incentives may be used to increase medication use and self-efficacy for quitting smoking, which offers an indirect way to increase successful smoking cessation. IMPLICATIONS: (1) This is the first study investigating via which psychological pathways financial incentives for quitting smoking can lead to long-term quit success. (2) The results showed a path between financial incentives and a higher likelihood of medication use. Incentives may encourage smokers to use medication in order to increase their chance of quitting smoking and receive the reward. (3) There was a path from financial incentives to quit success via a higher self-efficacy. (4) The effects of financial incentives did not depend on individual reward responsiveness.

Comparative Safety of Smoking Cessation Pharmacotherapies During a Government-Sponsored Reimbursement Program.

INTRODUCTION: The British Columbia Ministry of Health launched a Smoking Cessation Program on September 30, 2011, providing financial coverage for smoking cessation pharmacotherapies. Although pharmacotherapies have been shown to have a moderate short-term benefit as a quitting aid, substantial cardiovascular and neuropsychiatric safety concerns have been identified in adverse-reporting databases, leading to prescription label warnings by Health Canada and the U.S. Food and Drug Administration. However, recent studies indicate these warnings may be without merit. This study examined the comparative safety of medications commonly used to aid smoking cessation. AIMS AND METHODS: Population-based retrospective cohort study using B.C. administrative data to assess the relative safety between varenicline, bupropion, and nicotine replacement therapies (NRTs). The primary outcome was a composite of cardiovascular hospitalizations. Secondary outcomes included mortality, a composite of neuropsychiatric hospitalizations, and individual components of the primary outcome. Statistical analysis used propensity score-adjusted log-binomial regression models. A sensitivity analysis excluded patients with a history of cardiovascular disease. RESULTS: The study included 116 442 participants. Compared with NRT, varenicline was associated with a 10% 1-year relative risk decrease of cardiovascular hospitalization (adjusted risk ratio [RR] = 0.90, 95% confidence interval (CI): 0.82 to 1.00), a 20% 1-year relative risk decrease of neuropsychiatric hospitalization (RR: 0.80, CI: 0.7 to 0.89), and a 19% 1-year relative risk decrease of mortality (RR: 0.81, CI: 0.71 to 0.93). We found no significant association between NRT and bupropion for cardiovascular hospitalizations, neuropsychiatric hospitalizations, or mortality. CONCLUSIONS: Compared with NRT, varenicline is associated with fewer serious adverse events and bupropion the same number of serious adverse events. IMPLICATIONS: This study addresses the need for comparative safety evidence in a real-world setting of varenicline and bupropion against an active comparator. Compared with NRT, varenicline was associated with a decreased risk of mortality, serious cardiovascular events, and neuropsychiatric events during the treatment, or shortly after the treatment, in the general population of adults seeking pharmacotherapy to aid smoking cessation. These results provide support for the removal of the varenicline boxed warning for neuropsychiatric events and add substantively to the cardiovascular safety findings of previous observational studies and randomized clinical trials.

Nicotine replacement treatment, e-cigarettes and an online behavioural intervention to reduce relapse in recent ex-smokers: a multinational four-arm RCT.

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.

Stop smoking services help people to stop smoking over a short period of time. However, nearly three-quarters of quitters return to smoking (i.e. relapse) within 1 year. Effective relapse prevention strategies are needed. Traditional behavioural relapse prevention strategies (e.g. teaching techniques to resist having a cigarette) have not proved effective. However, an earlier study showed that an online programme guiding smokers in stopping smoking and remaining abstinent reduced relapse between 1 week and 6 months. Long-term use of stop smoking medications (e.g. nicotine replacement treatment) can also help, but most successful quitters do not continue to use them. Nicotine mouth spray, lozenges or electronic cigarettes that can quickly help relieve urges to smoke and that ex-smokers can use 'in emergencies' could be a more attractive option. We planned to test these two interventions, on their own and together, in 1400 participants who had quit ≥ 4 weeks previously and who were recruited from English stop smoking services and Australian quitlines. We would then compare these participants with the participants following usual care (i.e. access to stop smoking medications used during the quit attempt for up to 3 months). Owing to delays in study set-up and difficulties in recruiting, the study recruited only 234 participants (n = 131 in Australia and n = 103 in England). We studied participants' reactions to the two interventions and to their combination, and how clinically effective the interventions were. Both interventions were rated positively by most participants. Among the participants in Australia, electronic cigarettes were more popular than medical nicotine products. In England, both products were equally popular. Participants in the online intervention group appreciated the advice on coping strategies, but they rarely completed repeat assessments. In addition, participants who were not in this group used the strategies just as much. There were hints that the interventions may be helpful in preventing relapse. There is an indication that the two interventions combined did not do any better than each on its own, but this requires replication in a larger study. Although the interventions show promise, the small number of participants recruited means that we are unable to make strong conclusions. The study identified areas for future work.

Inequalities, harm reduction and non-combustible nicotine products: a meta-ethnography of qualitative evidence.

BACKGROUND: We sought to review qualitative evidence on how smokers in different socioeconomic groups engage with non-combustible nicotine products (NCNP), including electronic cigarettes and nicotine replacement therapies, in order to provide insight into how these products might impact on smoking inequalities. METHODS: We searched ten electronic databases in February 2017 using terms relating to NCNP and socioeconomic status. We included qualitative studies that were published since 1980 and were available in English. We used guidelines adapted from the Critical Appraisal Skills Programme for appraising qualitative research. RESULTS: The review only identified studies exploring the attitudes of socioeconomically disadvantaged smokers towards NCNP for harm reduction or cessation purposes (i.e. we did not identify any relevant studies of more advantaged socioeconomic groups). Using a lines-of-argument meta-ethnographic approach, we identified a predominantly pessimistic attitude to NCNP for harm reduction or cessation of smoking due to: wider circumstances of socioeconomic disadvantage; lack of a perceived advantage of alternative products over smoking; and a perceived lack of information about relative harms of NCNP compared to smoking. Optimistic findings, although fewer, suggested the potential of NCNP being taken up among smokers experiencing socioeconomic disadvantage. CONCLUSIONS: Overall, our review highlights the importance of considering the social, cultural and economic circumstances that influence experiences of smoking and of alternative product use.

Going Once, Going Twice: Using Willingness-to-Accept Auctions to Promote Smoking Cessation.

INTRODUCTION: Incentive-based smoking cessation interventions increase quit rates. The optimal incentive, however, is unknown. We used a willingness-to-accept (WTA) auction where smokers submitted bids indicating the incentive they would need to receive for 1 week of smoking cessation. AIMS AND METHODS: Smokers ready to quit (n = 35) participated in a WTA auction, naming the amount they needed to be paid to quit for 1 week. Auction winners received an incentive if they successfully quit. All smokers received nicotine replacement therapy and self-help cessation materials. Carbon monoxide concentrations were monitored remotely three times during the week and in person at the final session. RESULTS: Participants who smoked their first cigarette within 5 min of waking demanded a significantly larger incentive in exchange for quitting than those who waited (p < .05). About 45% of auction winners quit smoking compared to 20% of nonwinners (p < .05). The cost per quit was $466 among auction winners compared to $894 among nonwinners. CONCLUSIONS: WTA auctions may be an effective way to determine the amount smokers need to be paid to quit, which would allow researchers to estimate the most cost-effective payment to offer as part of incentive-based smoking cessation programs. Replication evaluating longer-term cessation outcomes with larger samples is warranted. IMPLICATIONS: Incentive-based smoking cessation interventions increase quit rates. However, the optimal incentive is unknown. We found that a WTA auction is a feasible technique for estimating the amount smokers need to be paid to quit. Incentives are a surprisingly cost-effective way to facilitate smoking cessation because they are only paid to those who successfully quit. WTA auctions are a promising tool for determining the incentive that strikes the optimal balance between being large enough to motivate cessation, but small enough that it can be offered to the largest possible population of smokers for a given program budget.

Disparities in hospital smoking cessation treatment by immigrant status.

Despite the efficacy of nicotine replacement therapy (NRT) in promoting smoking cessation, no studies have been done to evaluate NRT prescribing rates among immigrants, a vulnerable minority population in the United States. The aim of this study is to explore for differences in NRT prescribing behavior by immigrant status. Participants were enrolled in a smoking cessation trial for hospitalized patients between July 2011 and April 2014 at two NYC hospitals. For this analysis, we used baseline data from patient surveys and electronic medical-record reviews to examine associations between immigrant status and prescription of NRT in-hospital and on discharge, as well as acceptance of NRT in-hospital. We included age, gender, education, health literacy, race, ethnicity, English language ability, inpatient service, and site insurance in the models as potential confounders. Our study population included 1,608 participants, of whom 21% were not born in the United States. Bivariate analysis found that nonimmigrants were more likely than immigrants to be prescribed NRT in the hospital (46.1% vs. 35.7%, p = .0006) and similarly on discharge (19.4% vs. 15.3%, p = .09). Both groups were equally likely to accept NRT in-hospital when prescribed. On multivariable analysis, being an immigrant (OR 0.65), Black race (OR 0.52), and Hispanic ethnicity (OR 0.63) were associated with lower likelihood of being prescribed NRT in-hospital. Multivariable analysis for provision of NRT prescription at discharge showed no significant difference between immigrants and nonimmigrants. These findings show differences in in-hospital smoking cessation treatment between immigrants and nonimmigrants.

Population-level predictors of changes in success rates of smoking quit attempts in England: a time series analysis.

AIMS: To quantify associations between the success of smoking quit attempts and factors that have varied throughout 2007-2018 at a population level. DESIGN: time series analysis using Autoregressive Integrated Moving Average with Exogeneous Input (ARIMAX) modelling. SETTING AND PARTICIPANTS: Data were aggregated from 54 847 past-year smokers taking part in the Smoking Toolkit Study which involves monthly repeated cross-sectional household surveys of individuals aged 16+ in England. MEASUREMENTS: The input series were: (1) attempts at smoking reduction using (a) e-cigarettes and (b) nicotine replacement therapy (NRT); (2) use during a quit attempt of (a) e-cigarettes, (b) NRT over-the-counter, (c) medication on prescription and (d) face-to-face behavioural support; (3) use of roll-your-own tobacco; (4) prevalence of (a) smoking and (b) non-daily smoking; (5) tobacco control mass media expenditure; (6) expenditure on smoking; (7) smoker characteristics in the form of (a) high motivation to quit, (b) average age, (c) socio-economic status and (d) cigarette consumption; (8) implementation of tobacco control policies; and (9) quit attempt rate. FINDINGS: The licensing of NRT for harm reduction was associated with a 0.641% [95% confidence interval (CI) = 0.073-1.209, P = 0.027] increase in the mean point prevalence of the success rate of quit attempts. For every 1% increase in the mean point prevalence of e-cigarette use and use of prescription medication during a quit attempt, the mean point prevalence of successful quit attempts increased by 0.106% (95% CI = 0.011-0.201, P = 0.029) and 0.143% (95% CI = 0.009-0.279, P = 0.038), respectively. For every 1% increase in the mean expenditure on tobacco control mass media, the mean point prevalence of successful quit attempts increased by 0.046% (95% CI = 0.001-0.092, P = 0.046). Other associations were not statistically significant. CONCLUSION: In England between 2007 and 2018, licensing of nicotine replacement therapy for use in harm reduction, greater use of e-cigarettes and prescription medications during a quit attempt and higher expenditure on tobacco control mass media were all associated with higher success rates of quit attempts.

Potential for non-combustible nicotine products to reduce socioeconomic inequalities in smoking: a systematic review and synthesis of best available evidence.

BACKGROUND: While some experts have emphasised the potential for e-cigarettes to facilitate cessation among smokers with low socioeconomic status (SES), there is limited evidence of their likely equity impact. We assessed the potential for electronic cigarettes and other non-combustible nicotine-containing products (NCNPs) to reduce inequalities in smoking by systematically reviewing evidence on their use by SES in countries at stage IV of the cigarette epidemic. METHODS: Ten electronic databases were searched in February 2017 using terms relating to e-cigarettes, smokeless tobacco and nicotine replacement therapy (NRT); and SES. We included studies published since 1980 that were available in English and examined product use by SES indicators such as income and education. Data synthesis was based on those studies judged to be of medium- to high-quality using guidelines adapted from the Critical Appraisal Skills Programme. RESULTS: We identified 54 studies describing NCNP use by SES across 12 countries, of which 27 were judged of sufficient quality to include in data synthesis. We found mixed patterns of e-cigarette current use by SES, with evidence of higher use among low-income adults but unclear or mixed findings by education and occupation. In contrast, smokeless tobacco current use was consistently higher among low SES adults. There was very limited evidence on the SES distribution of NRT in adults and of all NCNPs in young people. CONCLUSIONS: The only NCNP for which there are clear patterns of use by SES is smokeless tobacco, where prevalence is higher among low SES groups. While this suggests a potentially positive impact on inequalities in smoking (if NCNP use displaces smoked tobacco use), this has not been seen in practice. These findings do not support the suggestion that e-cigarettes have the potential to reduce social inequalities in smoking, since i) current evidence does not show a clear trend of higher e-cigarette use in population groups with higher tobacco consumption, and ii) the experience of smokeless tobacco suggests that - even where NCNP use is higher among low SES groups - this does not necessarily replace smoked tobacco use in these groups.

E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT.

BACKGROUND: Over 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. OBJECTIVE: The objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support. DESIGN: A randomised controlled trial comparing e-cigarettes and NRT. SETTING: Three sites that provide local SSSs. PARTICIPANTS: The 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. INTERVENTIONS: The 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 MEASURES: The 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. RESULTS: The 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 < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ2 = 161.4; p < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective. LIMITATIONS: The results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes. CONCLUSIONS: Within 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 WORK: The 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 REGISTRATION: Current Controlled Trials ISRCTN60477608. 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. 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).

Alarge number of smokers in the UK have stopped smoking with the help of e-cigarettes, but it is not known if e-cigarettes are as helpful as stop smoking medications that are provided by the UK Stop Smoking Services (SSSs). This information is needed to decide whether or not SSSs should include e-cigarettes among their treatment options. A total of 886 smokers who were seeking help with quitting and did not mind whether they would use nicotine replacement therapy (NRT), such as nicotine patches, or e-cigarettes were recruited at three SSSs. The smokers were randomly allocated (by chance) to receive weekly behavioural support and either a NRT of their choice (a single NRT product or product combinations) (n = 447) or a starter pack of e-cigarettes (n = 439). The trial ran from May 2015 to February 2018. The participants were followed up for 1 year to see how many stopped smoking in each group. Smokers using e-cigarettes suffered less cigarette withdrawal discomfort early on and had higher quit rates at all time points. At 1 year, 10% of participants in the NRT trial arm had been abstinent for the whole year, compared with 18% in the e-cigarette arm; regarding abstinence for at least 6 months, the figures were 12% in the NRT arm and 21% in the e-cigarette arm. Of interest, coughs and phlegm production also reduced more in people quitting with e-cigarettes than those quitting with NRT. This supports previous reports suggesting that an ingredient in e-cigarettes (i.e. propylene glycol) may protect vapers from airborne infections. E-cigarette starter packs cost much less than NRT and so, if SSSs provide them, their use is likely to boost the success rates and reduce the costs of SSSs.

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network.

BACKGROUND: Population-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters. OBJECTIVE: To determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters. DESIGN: 3-arm pragmatic randomized controlled trial. PARTICIPANTS: Current smokers ≥ 18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n = 5225) and recruited using automated phone calls. INTERVENTIONS: One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral). MEASUREMENTS: Proportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment. KEY RESULTS: Of 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p < 0.001), cessation medication prescription (52% vs. 30%, p = 0.002), and counseling (47% vs. 9%, p < 0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources. CONCLUSIONS: Smokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system-based or community-based program compared with usual care. The health system-based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612895.

Improving smoking cessation care in pregnancy at Aboriginal Medical Services: 'ICAN QUIT in Pregnancy' step-wedge cluster randomised study.

OBJECTIVES: This study aimed to examine the impact of the 'ICAN QUIT in Pregnancy' intervention on individual health providers (HPs) smoking cessation care (SCC) knowledge, attitudes and practices in general, and specifically regarding nicotine replacement therapy (NRT) prescription. DESIGN: Step-wedge clustered randomised controlled study. HPs answered a preintervention and 1-6 months postintervention survey. SETTING: Six Aboriginal Medical Services (AMSs) in three states of Australia. PARTICIPANTS: All HPs were invited to participate. Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40%). INTERVENTION: Included three 1-hour webinar sessions, educational resource package and free oral NRT. OUTCOMES: HPs knowledge was measured using two composite scores-one from all 24 true/false statements, and one from 12 NRT-specific statements. Self-assessment of 22 attitudes to providing SCC were measured using a five-point Likert scale (Strongly disagree to Strongly agree). Two composite mean scores were calculated-one for 15 general SCC attitudes, and one for 7 NRT-specific attitudes. Self-reported provision of SCC components was measured on a five-point Likert scale (Never to Always). Feasibility outcomes, and data collected on the service and patient level are reported elsewhere. RESULTS: Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32). Mean NRT-specific knowledge composite score also improved (68% vs 79% correct, difference 9.9, 95% CI 3.66 to 16.14). Mean attitude composite score improved (3.65 (SD 0.4) to 3.87 (SD 0.4), difference 0.23, 95% CI 0.05 to 0.41). Mean NRT-specific attitudes composite score also improved (3.37 (SD 0.6) to 3.64 (SD 0.7), difference 0.36, 95% CI 0.13 to 0.6). Self-reported practices were unchanged, including prescribing NRT. CONCLUSIONS: A multicomponent culturally sensitive intervention in AMSs was feasible, and might improve HPs provision of SCC to pregnant Aboriginal women. Changes in NRT prescription rates may require additional intensive measures. TRIAL REGISTRATION NUMBER: ACTRN 12616001603404; Results.

Offenders' perceptions of the UK prison smoking ban.

PURPOSE: Despite overall reductions in levels of smoking in the UK, rates of offender smoking remain high. In 2016, it was announced that prisons in England and Wales would gradually introduce a smoking ban. The purpose of this paper is to explore offenders' perceptions around the upcoming smoking ban. DESIGN/METHODOLOGY/APPROACH: A total of eight focus groups were conducted in four prisons across the North of England. Both smoking and non-smoking offenders participated in the focus groups, and thematic analysis was used to explore the findings. FINDINGS: Themes generated from the data were "freedom and rights", "the prison environment" and "guiding support". Participants discussed how the smoking ban was viewed as a punishment and restricted their freedom, with perceptions as to why the ban was being implemented centring around others trying to control them. Participants expressed concerns around the financial implications of the smoking ban on already stretched prison resources. Participants also recommended improving the nicotine replacement therapy on offer, and increasing the range of leisure activities within the prison to prepare for the smoking ban. ORIGINALITY/VALUE: Overall, it was apparent that participants' awareness of the smoking ban was generally poor. It is recommended that offenders need to be made more aware of the smoking cessation support they will receive and given the opportunity to ask questions about the smoking ban. Increasing offenders' awareness of the ban may reduce stress associated with a perceived lack of choice around their smoking behaviours.

E-cigarettes helped more smokers quit than nicotine replacement therapy.

The studyHajek P, Phillips-Waller A, Przulj D, et al. A randomised trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med 2019;380:629-37.This trial was funded by the NIHR Health Technology Assessment Programme (12/167/135) and by Cancer Research UK.To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000757/e-cigarettes-helped-more-smokers-quit-than-nicotine-replacement-therapy.

Knowledge and Education as Barriers and Facilitators to Nicotine Replacement Therapy Use for Smoking Cessation in Pregnancy: A Qualitative Study with Health Care Professionals.

Smoking during pregnancy is a leading cause of negative pregnancy and perinatal outcomes. While UK guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy, adherence to NRT is generally low and may partially explain why NRT appears less effective in pregnancy compared to non-pregnant smokers. This study aimed to identify and describe factors associated with NRT adherence from a health professional's perspective. Two focus groups and one expert group were conducted with 26 professionals involved in antenatal stop smoking services and the data were analysed thematically using a template methodology. From our analyses, we extracted two main themes: (i) 'Barriers to NRT use in pregnancy' explores the issues of how misinformation and unrealistic expectations could discourage NRT use, while (ii) 'Facilitators to NRT use in pregnancy' describes the different information, and modes of delivery, that stop smoking professionals believe will encourage correct and sustained NRT use. Understanding the barriers and facilitators to improve NRT adherence may aid the development of educational interventions to encourage NRT use and improve outcomes for pregnant women wanting to stop smoking.

Clinical Effectiveness of Traditional and Complementary Medicine Interventions in Combination with Nicotine Replacement Therapy on Smoking Cessation: A Randomized Controlled Pilot Trial.

Background: Smoking is associated with many preventable diseases and deaths. Globally, more than 6 million deaths per year are related to smoking. This study aimed to evaluate the pragmatic effectiveness of traditional and complementary medicine (T&CM) interventions for the smoking cessation treatment and to calculate the incremental cost-effectiveness ratio (ICER) of these interventions. Methods: The study design was a pragmatic, open-label randomized trial. The hypothesis of this trial was that the smoking cessation success rate increases with the addition of T&CM methods. The intervention group was provided T&CM interventions in addition to nicotine replacement therapy (NRT) and counseling, whereas the control group was treated with only NRT and counseling. Individuals received treatment for 4 weeks, then follow-up care for 20 weeks. Results: Forty-one participants were enrolled and assigned to either an intervention group or a control group at a ratio of 1:1. The odds ratio values at 4 weeks were 1.96 (0.51-8.51) in intention-to-treat analysis and 3.27 (0.75-17.75) in per-protocol analysis. The amount of smoking (cigarettes) decreased in both groups: from 17.2 ± 10.31 (baseline) to 1.7 ± 3.02 (4 weeks) in the intervention group and from 12.9 ± 5.47 (baseline) to 3.3 ± 5.96 (4 weeks) in the control group. The total medical costs per patient were $212.20 USD in the intervention group and $170.80 in the control group. The adjusted ICER of T&CM interventions was $13,355. Conclusions: This pilot study evaluated the clinical feasibility of T&CM used in conjunction with NRT and counseling for the smoking cessation treatment. However, there was no statistically significant effectiveness of T&CM interventions to raise cessation success rate. This study demonstrates the necessity for further studies based on large-scale randomized controlled trials.

Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity.

Objective: The exclusion criteria of tobacco cessation randomized clinical trials (RCTs) may have unintended consequences on inclusion and cessation disparities. We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion. Design: Quasi-experimental. Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English. Data were obtained from a parent trial, which is ongoing and will be completed in 2019. Analyses for our present study on participant screening and enrollment were conducted in 2018. Main Outcome Measures: Study ineligibility, and reasons for exclusion (contraindications for nicotine patch use, serious mental illness [SMI, eg, bipolar disorder or schizophrenia], alcohol dependence or illicit drug use, current tobacco treatment, attendance barriers [eg, transportation], and other concerns [eg, aggressive, intoxicated, disruptive, visibly ill]). Results: Of 1,206 individuals screened, 36% were ineligible. The most frequent reasons were SMI (28%), alcohol dependence or drug use (10%), and attendance barriers (7%). Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P<.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P<.05). Conclusions: A notable proportion of smokers were ineligible for this RCT, with SMI as the greatest single cause. Racial/ethnic minorities were more likely to be excluded, with African Americans deemed ineligible for multiple reasons. Findings have implications for RCT generalizability, addressing tobacco disparities and health equity.

Factors associated with Quitline and pharmacotherapy utilisation among low-socioeconomic status smokers.

AIMS: To examine factors associated with Quitline and pharmacotherapy utilisation in low socioeconomic status (low-SES) smokers enrolled in a smoking cessation trial. METHODS: 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. RESULTS: 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). CONCLUSION: 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.