Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol

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

Empowering smokers with a web-assisted tobacco intervention to use prescription smoking cessation medications: a feasibility trial

“…Abstinence was not biochemically verified in the current study. A future trial designed to assess effectiveness of this intervention could verify abstinence by collecting saliva samples through the mail to determine salivary cotinine levels [ 43 ]. Finally, without knowing the number of smokers to whom information about the study was disseminated, the fact that we were able to recruit 500 eligible smokers within 6 months is not an entirely informative indicator of the success of our recruitment efforts.…”

Impact of self-reported lifetime depression or anxiety on effectiveness of mass distribution of nicotine patches

“…A detailed research protocol has been published elsewhere 37. Briefly, this RCT employed a single-blinded, survey design with random assignment to an experimental and a control condition.…”

“…In the context of a large randomised controlled trial (RCT) examining the efficacy of mailed distribution of NRT to Canadian smokers,37 the objective of the current study was to examine the influence of lifetime history of depression and/or anxiety on smoking cessation success following the free distribution of nicotine patches. The randomised trial recruited participants who were interested in receiving free nicotine patches and compared quit rates between participants who were sent a 5-week course of nicotine patches (without behavioural assistance) and those who were not offered the patches.…”

Effect of Mailing Nicotine Patches on Tobacco Cessation Among Adult Smokers

“…The research was approved by the institutional review board at the Centre for Addiction and Mental Health. The published protocol 14 was approved by the institutional review board at the Centre for Addiction and Mental Health before trial initiation.…”

“…Full details of the sample size calculations and statistical analyses can be found in the trial protocol in the Supplement. 14 In brief, based on data from the 2008 Canadian Tobacco Use Monitoring Survey, 15 we estimated that a baseline smoking cessation rate of 3.7% would be observed in the control group at 6 months. This estimate was consistent with another report 16 of successful unassisted long-term abstinence rates of 3% to 5%.…”