Use Of Stop-smoking Medications Research Articles

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

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. A randomised controlled trial. English stop smoking services and Australian quitlines, Australian social media and St Vincent's Hospital Melbourne, Fitzroy, VIC. 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. 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). 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. 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. 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. 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. Further studies of both interventions are warranted, using simpler study designs. Current Controlled Trials ISRCTN11111428. 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.

Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial.

Within the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits. Cluster-randomized clinical trial. Twenty-two primary care clinics in South Carolina, USA. Adult smokers [n=1245; 61% female, mean age=50.7, standard deviation (SD)=13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n=652, 12 clinics) cessation advice or SC+a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n=593; 10 clinics). The primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6months following baseline. Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6months [12 versus 8%, odds ratio (OR)=1.5, 95% confidence interval (CI)=1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR=5.8, 95% CI=4.3-7.7), with higher prevalence of use at 6months (25 versus 14%, OR=2.0, 95% CI=1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR=1.5, 95% CI=1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR=1.2, 95% CI=0.8-1.7). Providing smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.

Do predictors of smoking relapse change as a function of duration of abstinence? Findings from the United States, Canada, United Kingdom and Australia.

To estimate predictors of time to smoking relapse and test if prediction varied by quit duration. Longitudinal cohort data from the International Tobacco Control Four-Country survey with annual follow up collected between 2002 and 2015. Canada, United States, United Kingdom and Australia. A total of 9171 eligible adult smokers who had made at least one quit attempt during the study period. Time to relapse was the main outcome. Predictor variables included pre-quit baseline measures of nicotine dependence, smoking and quitting-related motivations, quitting capacity and social influence, and also two post-quit measures, use of stop-smoking medications and quit duration (1-7days, 8-14days, 15-31days, 1-3months, 3-6months, 6-12months, 1-2years and 2+ years), along with socio-demographics. All factors were predictive of relapse within the first 6months of quitting but only wanting to quit, quit intentions and number of friends who smoke were still predictive of relapse in the 6-12-month period of quitting [hazard ratios (HR)=1.20, P< 0.05; 1.13, P< 0.05; and 1.21, P<0.001, respectively]. Number of friends smoking was the only remaining predictor of relapse in the 1-2years quit period (HR=1.19, P=0.001) with none predictive beyond the 2-year quit period. Use of stop-smoking medications during quit attempts was related negatively to relapse during the first 2weeks of quitting (HR=0.71-0.84), but related positively to relapse in the 1-6-month quit period (HR=1.29-1.54). Predictive effects of all factors showed significant interaction with quit duration except for perceiving smoking as an important part of life, prematurely stubbing out a cigarette and wanting to quit. Among adult smokers in the United States, Canada, United Kingdom and Australia, factors associated with smoking relapse differ between the early and later stages of a quit attempt, suggesting that the determinants of relapse change as a function of abstinence duration.

Hospital Smoke-Free Policy: Compliance, Enforcement, and Practices. A Staff Survey in Two Large Public Hospitals in Australia.

Background: Smoke-free hospital policies are becoming increasingly common to promote good health and quit attempts among patients who smoke. This study aims to assess: staff perceived enforcement and compliance with smoke-free policy; the current provision of smoking cessation care; and the characteristics of staff most likely to report provision of care to patients. Methods: An online cross-sectional survey of medical, nursing, and allied staff from two Australian public hospitals was conducted. Staff report of: patient and staff compliance with smoke-free policy; perceived policy enforcement; the provision of the 5As for smoking cessation (Ask, Assess, Advise, Assist, and Arrange follow-up); and the provision of stop-smoking medication are described. Logistic regressions were used to determine respondent characteristics related to the provision of the 5As and stop-smoking medication use during hospital admission. Results: A total of 805 respondents participated. Self-reported enforcement of smoke-free policy was low (60.9%), together with compliance for both patients (12.9%) and staff (23.6%). The provision of smoking cessation care was variable, with the delivery of the 5As ranging from 74.7% (ask) to 18.1% (arrange follow-up). Medical staff (odds ratio (OR) = 2.09, CI = 1.13, 3.85, p = 0.018) and full time employees (OR = 2.03, CI = 1.06, 3.89, p = 0.033) were more likely to provide smoking cessation care always/most of the time. Stop-smoking medication provision decreased with increasing age of staff (OR = 0.98, CI = 0.96, 0.99, p = 0.008). Conclusions: Smoke-free policy enforcement and compliance and the provision of smoking cessation care remains low in hospitals. Efforts to improve smoking cessation delivery by clinical staff are warranted.

Feasibility of Implementing a Hospital-Based "Opt-Out" Tobacco-Cessation Service.

To assess the feasibility and outcomes of implementing a hospital-based "opt-out" tobacco-cessation service. In 2014, the Medical University of South Carolina adopted a policy that all hospitalized patients who self-report using tobacco be referred to tobacco-cessation service. This is a descriptive study of a real-world effort to implement guidelines for a hospital-based cessation service consistent with Joint Commission's standards. Between February 2014 and May 2015, 42 061 adults were admitted to the Medical University of South Carolina Hospital. Eligible current cigarette smokers were referred to the tobacco-cessation service, which consisted of a bedside consult and phone follow-up 3, 14, and 30 days after hospital discharge using interactive-voice-response. The primary study outcomes evaluated the proportions of smokers reached by the bedside counselor and/or phone follow-up, smokers who opted out, and smokers who self-reported not smoking when last contacted by phone. Records identified 8423 smokers, of whom 69.4% (n = 5843) were referred into the service. One full-time bedside counselor was able to speak with 1918 (32.8%) patients, of whom 96 (5%) denied currently smoking and 287 (14.9%) refused counselling. Reach at follow-up was achieved for 703 (55%) smokers who received bedside counselling and 1613 (49%) who did not, yielding an overall follow-up reach rate of 60%. Of those reached by phone, 36.4% reported not smoking (51% vs. 27% for those who did and did not receive bedside counselling, respectively). Intent-to-treat abstinence rate was 13.5% according to the last known smoking status. Findings from this study suggest that an inpatient smoking-cessation service with an "opt-out" approach can positively impact short-term cessation outcomes. (1) The findings demonstrate the feasibility of implementing an automated large-scale opt-out tobacco-cessation service for hospitalized patients that is consistent with the Joint Commission recommended standards for treating tobacco dependence. (2) Receiving a bedside tobacco-cessation consult while hospitalized increased the use of stop smoking medications and abstinence from smoking after discharge from the hospital. (3) Even in those patients who did not receive a bedside consult, 5% accepted a referral to the South Carolina Tobacco Quitline to get help to stop smoking.

Stop-Smoking Medication Use, Subsidization Policies, and Cessation in Canada.

In 2000, Quebec began reimbursing stop-smoking medications (SSMs) through their provincial public drug insurance plan. Several other Canadian provinces have since begun offering SSM subsidies. Clinical trials indicate that SSMs can increase quit success; however, little evidence exists on patterns of use in "real-world" settings and impact on population quit rates. This study examines Canadian trends in SSM use and quit success over time, comparing provinces with differing subsidization policies. Secondary analyses were conducted in 2014 using nationally representative Canadian Tobacco Use Monitoring Survey data, 2004-2012, for current and former smokers who made a quit attempt in the past 2 years (N=26,094). Regression models tested for differences in SSM use and quit success in provinces with differing SSM coverage (i.e., none, partial, or comprehensive). Smokers were more likely to use nicotine replacement therapy (NRT) in jurisdictions with comprehensive SSM coverage versus jurisdictions with partial (OR=1.39, 95% CI=1.22, 1.59) or no coverage (OR=1.43, 95% CI=1.21, 1.68). Prescription medication use was more likely in provinces with partial (versus no) coverage (OR=1.27, 95% CI=1.01, 1.59). Overall, smokers who attempted to quit were more likely to remain abstinent in jurisdictions with comprehensive versus partial (OR=1.20, 95% CI=1.12, 1.28) or no coverage (OR=1.23, 95% CI=1.00, 1.50). An interaction between coverage and cigarettes per day was observed, suggesting potentially greater impact of comprehensive coverage among heavier smokers. Comprehensive subsidization policies are associated with modest increases in NRT use and quit success, but do not appear to impact prescription SSM use.

Use of stop-smoking medications in the United States before and after the introduction of varenicline.

To evaluate trends in use of stop-smoking medications (SSMs) before and after varenicline (Chantix™) was introduced to the market-place in the United States, and to determine whether varenicline reached segments of the population unlikely to use other SSMs. Cohort survey. United States. A nationally representative sample of adult smokers in the United States interviewed as part of the International Tobacco Control Four Country Survey between 2004 and 2011. Primary analyses used cross-sectional data from 1737 smokers who attempted to quit (∼450 per wave). Reporting an attempt to quit smoking; use of each of the following types of SSMs for the purpose of quitting smoking: nicotine gum, nicotine patch, other nicotine replacement therapy, bupropion and varenicline. There was a significant increase in the rate of use of any SSM among quit attempters across the study period [odds ratio (OR) = 1.15, 95% confidence interval (CI) = 1.10-1.21 per year]. This increase was largest after varenicline was introduced (OR = 1.16, 95% CI = 1.07-1.26 per year); however, there was a decline in nicotine patch use during this time (OR = 0.87, 95% CI = 0.76-0.99 per year). Varenicline users were generally similar to users of other SSMs but differed from those who did not use any SSMs, in that they tended to be older (OR = 5.46, P = 0.024), to be white (OR = 2.33, P = 0.002), to have high incomes (OR = 1.85, P = 0.005), to have high nicotine dependence prior to quitting (OR = 2.40, P = 0.001) and to have used medication in the past (OR = 3.29, P < 0.001). The introduction of varenicline in the United States coincided with a net increase in attempts to quit smoking and, among these, a net increase in use of stop-smoking medications. The demographic profile of varenicline users is similar to the profile of those who use other stop-smoking medications and different from the profile of those who attempt to quit without any medication.

Heaviness of Smoking Predicts Smoking Relapse Only in the First Weeks of a Quit Attempt: Findings From the International Tobacco Control Four-Country Survey

The Heaviness of Smoking Index (HSI) is the measure of dependence most strongly predictive of relapse. However, recent research suggests it may not be predictive of longer-term relapse. Our aim was to examine its predictive power over the first 2 years after quitting and explore whether use of stop-smoking medications is a moderator. Data (n = 7,093) came from the first 7 waves (2002-2009) of the International Tobacco Control Four-Country Survey, an annual cohort survey of smokers in Canada, the United States, the United Kingdom, and Australia. HSI and its 2 components (cigarettes per day [CPD] and time to first cigarette [TTFC]) were used to predict smoking relapse risk in the 2 years after the start of a quit attempt. Scores on HSI and its components all strongly predicted relapse, but there was an interaction with time (p < .001). These measures were strong predictors of relapse within the first week of quitting (hazard ratios [HR] = 1.17, 1.24, and 1.30 for HSI, CPD, and TTFC, respectively; all p < .001), less predictive of relapse occurring between 1 week and 1 month, and not clearly predictive beyond 1 month. Among those using medication to quit, hazard ratio for HSI (HR = 1.11, p < .001) was significantly lower than for those not using (HR = 1.24, p < .001) in the first week but not beyond. HSI and its 2 components are strong predictors of short-term smoking relapse, but they rapidly lose predictive power over the first weeks of an attempt, becoming marginally significant at around 1 month and not clearly predictive beyond then.

The use of cessation assistance among smokers from China: Findings from the ITC China Survey.

BackgroundStop smoking medications significantly increase the likelihood of smoking cessation. However, there are no population-based studies of stop-smoking medication use in China, the largest tobacco market in the world. This study examined stop-smoking medication use and its association with quitting behavior among a population-based sample of Chinese smokers.MethodsFace-to-face interviews were conducted with 4,627 smokers from six cities in the ITC China cohort survey. Longitudinal analyses were conducted using Wave 1 (April to August, 2006) and Wave 2 (November 2007 to January 2008).ResultsApproximately 26% of smokers had attempted to quit between Waves 1 and 2, and 6% were abstinent at 18-month follow-up. Only 5.8% of those attempting to quit reported NRT use and NRT was associated with lower odds of abstinence at Wave 2 (OR = 0.11; 95%CI = 0.03-0.46). Visiting a doctor/health professional was associated with greater attempts to quit smoking (OR = 1.60 and 2.78; 95%CI = 1.22-2.10 and 2.21-3.49 respectively) and being abstinent (OR = 1.77 and 1.85; 95%CI = 1.18-2.66 and 1.13-3.04 respectively) at 18-month follow-up relative to the smokers who did not visit doctor/health professional.ConclusionsThe use of formal help for smoking cessation is low in China. There is an urgent need to explore the use and effectiveness of stop-smoking medications in China and in other non-Western markets.

Usage patterns of stop smoking medications in Australia, Canada, the United Kingdom, and the United States: findings from the 2006-2008 International Tobacco Control (ITC) Four Country Survey.

Varenicline is a new prescription stop smoking medication (SSM) that has been available in the United States since August 1, 2006, in the United Kingdom and other European Union countries since December 5, 2006, in Canada since April 12, 2007, and in Australia since January 1, 2008. There are few population-based studies that have examined use rates of varenicline and other stop smoking medications. We report data from the ITC Four Country survey conducted with smokers in the US, UK, Canada, and Australia who reported an attempt to quit smoking in past year in the 2006 survey (n = 4,022 participants), 2007 (n = 3,790 participants), and 2008 surveys (n = 2,735 participants) Respondents reported use of various stop smoking medications to quit smoking at each survey wave, along with demographic and smoker characteristics. The self-reported use of any stop smoking medication has increased significantly over the 3 year period in all 4 countries, with the sharpest increase occurring in the United States. Varenicline has become the second most used stop smoking medication, behind NRT, in all 4 countries since being introduced. Between 2006 and 2008, varenicline use rates increased from 0.4% to 21.7% in the US, 0.0% to 14.8% in Canada, 0.0% to 14.5% in Australia, and 0.0% to 4.4% in the UK. In contrast, use of NRT and bupropion remained constant in each country. Males and non-whites were significantly less likely to report using any SSM, while more educated smokers were significantly more likely to use any SSM, including varenicline. Our findings suggest that the introduction of varenicline led to an increase in the number of smokers who used evidence-based treatment during their quit attempts, rather than simply gaining market share at the expense of other medications. From a public health perspective, messages regarding increased success rates among medication users and the relative safety of stop smoking medications should be disseminated widely so as to reach all smokers of all socioeconomic classifications equally.

Trends in beliefs about the harmfulness and use of stop-smoking medications and smokeless tobacco products among cigarettes smokers: Findings from the ITC four-country survey.

BackgroundEvidence shows that smokers are generally misinformed about the relative harmfulness of nicotine, and smokeless forms of nicotine delivery in relation to smoked tobacco. This study explores changing trends in the beliefs about the harmfulness and use of stop smoking medications and smokeless tobacco in adult smokers in four countries where public education and access to alternative forms of nicotine is varied (Canada, the US, the UK and Australia).MethodsData are from seven waves of the ITC-4 country study conducted between 2002 and 2009 with adult smokers from Canada, the US, the UK and Australia. For the purposes of this study, data were collected from 21,207 current smokers. Using generalised estimating equations to control for multiple response sets, multivariate models were tested to look for main effects of country, and trends across time, controlling for demographic variables.ResultsKnowledge remained low in all countries, although UK smokers tended to be better informed. There was a small but significant improvement across time in the UK, but mixed effects in the other three countries. At the final wave, between 37.5% (US) and 61.4% (UK) reported that NRT is a lot less harmful than cigarettes. In Canada and the US, where smokeless tobacco is marketed, only around one in six believed some smokeless tobacco products could be less harmful than cigarettes.ConclusionsMany smokers continue to be misinformed about the relative safety of nicotine and alternatives to smoked tobacco, especially in the US and Canada. Concerted efforts to educate UK smokers have probably improved their knowledge. Further research is required to assess whether misinformation deters smokers from appropriate use of alternative forms of nicotine.

Stop-smoking medications: Who uses them, who misuses them, and who is misinformed about them?

This study assessed smokers' beliefs about nicotine and the safety of nicotine medications and examined how these beliefs influence the use of nicotine medications. The data for this paper came from a nationally representative, random-digit-dialed telephone survey of 1,046 adults (18 years of age and older) current cigarette smokers conducted between May and September 2001. Respondents were questioned about their use of stop smoking medications, beliefs about nicotine, and the safety/efficacy of nicotine medications. Nearly all adult smokers in our survey had heard of nicotine patches (97%) or gum (94%), with lower levels of awareness reported for the nicotine inhaler (41%), and nasal spray (9%). Thirty-eight percent of smokers had previously used nicotine medications, with the nicotine patch being the most commonly used medication. The data reveal that most smokers are misinformed about the health risks of nicotine and the safety/efficacy of nicotine medications. Approximately half incorrectly reported that the reduction in nicotine in cigarettes has made cigarettes less dangerous to health and only one-third correctly reported that nicotine patches were less likely to cause a heart attack than smoking cigarettes. Smokers who were more knowledgeable about the health risks of nicotine and the safety and efficacy of nicotine medications were more likely to report past use of nicotine medications. Misperceptions about the health risks of nicotine and the safety/efficacy of nicotine medications may discourage some smokers from considering the use of these medications to help them stop smoking.

Impact of economic policies on reducing tobacco use among Medicaid clients in New York

Background New York State (NYS) recently implemented Medicaid coverage for prescription pharmacologic adjuncts for cessation and a 55-cent excise tax on a pack of cigarettes. This study examined awareness and use of stop smoking medications and changes in smoking/purchasing behavior among Medicaid clients. Methods Participants ( n = 173) were English-speaking Medicaid clients ages 18–64 years who currently smoked cigarettes and volunteered to be interviewed while waiting to reregister with the NYC Medicaid Office during early 2001. Data were collected using a brief (10-min) interviewer-administered questionnaire. Results Over 80% of Medicaid clients reported some desire to stop smoking and 40% intended to stop smoking in the next 6 months. Awareness of Medicaid coverage for tobacco cessation pharmacotherapy was 7% for nicotine replacement therapy and 13% for bupropion. Use of these stop smoking medications varied across products but in general was low (<10%). Half of the Medicaid clients reported changing their smoking behavior as a result of the cigarette tax increase. Conclusions The majority of Medicaid clients report a desire to stop smoking, but these economic influences alone are insufficient to substantially reduce smoking in this population. These findings emphasize the importance of allocating a portion of tobacco tax revenue to promote both expanded awareness of this prescription benefit among Medicaid clients and to support programs to further assist low-income smokers in their attempts to stop smoking.

Cost-utility analysis.

Decisions have to be made about allocating health resources. Currently the best economic evaluation method for doing this is cost-utility analysis. This compares the costs of different procedures with their outcomes measured in "utility based" units--that is, units that relate to a person's level of wellbeing. The most commonly used unit is the quality adjusted life year (QALY). QALYs are calculated by estimating the total life years gained from a procedure and weighting each year to reflect the quality of life in that year. To compare outcomes of different programmes the Rosser index is one measure that is widely used to assign quality of life scores to patients. Combined with a measure of life years gained from a procedure, this enables QALYs to be calculated and procedures ranked according to cost per QALY gained. In this article Ray Robinson explains the measures used and discusses how QALY league tables can be used to guide decisions on resource allocation.