Abstract
BackgroundConsiderable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered - do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.Methods/DesignA single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.DiscussionThe findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.Trial RegistrationClinicalTrials.gov: NCT01429129
Highlights
Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population
The Public Health Service in the U.S has, over the years, examined over 8,700 research articles in order to prepare guidelines for the treatment of tobacco use and dependence [26]. They found that medications such as Nicotine Replacement Therapy (NRT) are effective in increasing longterm smoking abstinence rates and recommend that clinicians encourage their use
With the evidence supporting the efficacy of NRTs in successful smoking cessation and with the recommendations from these reviews promoting increased access to NRT for smokers, the undertaking of mass distribution of free NRT appears to be well founded
Summary
There has been extensive research evaluating the efficacy of NRT as a means to promote smoking cessation. The Public Health Service in the U.S has, over the years, examined over 8,700 research articles in order to prepare guidelines for the treatment of tobacco use and dependence [26]. They found that medications such as NRTs are effective in increasing longterm smoking abstinence rates and recommend that clinicians encourage their use. Employing a panel survey design, this randomized controlled trial will evaluate the effectiveness of free mass distribution of the nicotine patch to Canadian smokers interested in free NRT. If the project finds support for the effectiveness of supplying interested smokers with free NRT in order to help them quit, it would provide evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it
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