Smoking is a leading cause of preventable death worldwide and the leading cause of preventable cancer death. Tobacco use is responsible for approximately 33% of potential years of life lost (PYLL) due to all cancers in males and approximately 20% of PYLL due to all cancers in females . In males, it is also responsible for approximately 30% of PYLL due to diseases of the heart and 50% of PYLL due to respiratory diseases . In 2002, over 2 million acute care hospital days (10.3% of all acute care hospital days) in Canada were attributable to smoking . The cost of these smoking-attributable acute care hospital days exceeded $2.5 billion.
Approximately 18% of the adult Canadian population (20% of males and 16% of females) were identified as current smokers in 2008. Although this proportion has declined from 25% in 1999, it still represents 4.9 million Canadian smokers . Quitting smoking conveys numerous immediate, intermediate and long term health benefits. For example, coronary heart disease risk is reduced by 50% after 12 months without smoking, and after 15 years the risk is as low as that of a non-smoker. Ten years after quitting the mortality rate from lung cancer is about half that of a continuing smoker . Helping smokers quit smoking should be a public health priority.
In a systematic assessment of the value of clinical preventive services recommended by the U.S. Preventive Services Task Force, smoking cessation treatment for adults was one of the highest ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease [5, 6]. Smoking cessation services compare favorably with other routine preventive health care interventions such as screening for hypertension and annual mammography. Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices. For example, cost effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality (AHRQ)  guidelines show costs of $4,113 per life-year saved, in 2001 prices. This compares favorably to annual mammography for women aged 40 to 49 years, which costs $71,751 in 2001 prices, and hypertension screening for men aged 40+ years, which costs $27,117 in 2001 prices. A British systematic analysis of smoking cessation interventions found that Nicotine Replacement Therapy (NRT) costs between £1000 and £2400 per year of life saved .
Large scale consumer consensus and population research conducted across parts of the U.S. and Canada has shown that mailed free NRT is an effective way of promoting smoking cessation and of helping motivated smokers who want to quit. Research conducted in New York State found that 53% of smokers indicated that the free distribution of NRT would be most effective in motivating them to think seriously about stopping smoking . A Canadian population survey similarly found that 58.9% of ≥ 10 cigarettes per day smokers expressed interest in receiving free nicotine patches and of those, almost all indicated they would use nicotine patches to quit permanently . Heavier smokers were more likely than less heavy smokers to be interested in receiving free NRT.
In an effort to increase access to smoking cessation therapies, one program in New York State provided over 40,000 smokers who called in to a Smokers' Quitline with one to six weeks of free nicotine patches or vouchers for two weeks of NRT. Evaluation of the giveaway program revealed that Quit rates four months later varied from 21% (among smokers receiving one week of NRT for free) to 35% (among smokers receiving 6 weeks of NRT for free). This compared with a quit rate of 12% among an earlier comparison group of callers to the Quitline (not randomly assigned) who received counseling support and some self-help materials but no NRT . In Ontario, Canada, the STOP Study has distributed free NRT and thus far has been responsible for the delivery of 5 weeks of free NRT to approximately 58,000 smokers (representing roughly 33% of adult Ontario smokers who smoke ≥ 10 cigarettes a day and who report wanting to quit in the next 30 days) . As part of a call centre-based mass distribution initiative, end-of-treatment quit rate (using 7 day point prevalence) was estimated to be 15% (the calculation used as the denominator all those who were sent NRT and assumed that all recipients who did not complete their end-of-treatment survey had not quit). At the 6-month follow-up period, the quit rate based on 30 day point prevalence was estimated to be approximately 9% . Of particular note, the majority (76%) of smokers in the STOP Study requested nicotine patches as their desired form of NRT.
Overall, the existing research suggests that smokers are interested in easier access to smoking cessation therapies, and that the receipt of such therapies, including free NRT, seems to be associated with increased rates of quitting smoking. However, none of the studies exploring increased availability of NRT through mass distribution were randomized controlled trials. As a result, the findings are suggestive but do not permit causal inference. Additionally, biochemical verification of self-report abstinence was not performed in these studies. Considerable money has been invested in mass distribution of free NRT in Ontario and similar initiatives are being undertaken or contemplated in other provinces. It is important at this stage to conduct a randomized controlled study to determine the efficacy of large scale distribution of free NRT.
Aim of the study
This study will attempt to answer the question, "does mass distribution of the nicotine patch actually work (i.e., increase quit rates significantly above those who do not receive free nicotine patches)?" By conducting a randomized controlled trial of free mass NRT distribution, this study will evaluate the efficacy of the mass distribution approach. Comparison of an experimental group which will be offered free nicotine patches to a control group that does not get offered nicotine patches will determine whether or not mass distribution of NRT is an effective way of helping smokers quit. It is hypothesized that among eligible Canadian smokers expressing interest in receiving free nicotine patches, those randomly selected to be offered 5 weeks of free nicotine patches will exhibit a significantly greater quit rate at 8 weeks and 6-month follow-ups compared to those not offered free nicotine patches (saliva cotinine measurements used to validate self-reported smoking abstinence). Previously it has been shown that those who metabolize nicotine more quickly have significantly poorer cessation rates on nicotine patch than slow metabolizers . Therefore this study will also explore whether fast nicotine metabolizers (as measured by the 3-Hydroxycotinine/cotinine ratio) will be less likely to succeed at quitting smoking, as compared to slow nicotine metabolizers, when offered free nicotine patches. Finally, the study will investigate how compliance with recommended amount of NRT, and whether prior use of NRT, affects success at quitting smoking when smokers are offered free nicotine patches.