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

Cunningham JA, Leatherdale ST, Selby PL, Tyndale RF, Zawertailo L, Kushnir V - BMC Public Health (2011)

Bottom Line: Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population.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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for Addiction and Mental Health, 33 Russell St, Toronto M5S 2S1, Canada. john_cunningham@camh.net

ABSTRACT

Background: Considerable 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/design: A 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.

Discussion: The 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 registration: ClinicalTrials.gov: NCT01429129.

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Related in: MedlinePlus

Overview of the proposed intervention trial.
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Figure 1: Overview of the proposed intervention trial.

Mentions: As part of the baseline survey, eligible subjects will be identified for the second stage of the recruitment process and will be randomized into experimental and control conditions to receive versus not receive nicotine patches. Eligibility will be determined by a series of questions regarding hypothetical interest in nicotine patches to quit smoking (including willingness to have nicotine patches sent to their home) and having no contraindications for using NRT. A randomized half of the eligible subjects will be assigned to the experimental condition and asked for their permission to have nicotine patches sent to their home. These subjects will have 5 weeks of nicotine patches sent to their homes to help them quit smoking. Subjects in the control condition will not be offered nicotine patches. Only subjects in the randomized controlled trial will be followed-up at 8 weeks and 6 months. See Figure 1 for a CONSORT diagram of the proposed study design.


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

Cunningham JA, Leatherdale ST, Selby PL, Tyndale RF, Zawertailo L, Kushnir V - BMC Public Health (2011)

Overview of the proposed intervention trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3198706&req=5

Figure 1: Overview of the proposed intervention trial.
Mentions: As part of the baseline survey, eligible subjects will be identified for the second stage of the recruitment process and will be randomized into experimental and control conditions to receive versus not receive nicotine patches. Eligibility will be determined by a series of questions regarding hypothetical interest in nicotine patches to quit smoking (including willingness to have nicotine patches sent to their home) and having no contraindications for using NRT. A randomized half of the eligible subjects will be assigned to the experimental condition and asked for their permission to have nicotine patches sent to their home. These subjects will have 5 weeks of nicotine patches sent to their homes to help them quit smoking. Subjects in the control condition will not be offered nicotine patches. Only subjects in the randomized controlled trial will be followed-up at 8 weeks and 6 months. See Figure 1 for a CONSORT diagram of the proposed study design.

Bottom Line: Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population.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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for Addiction and Mental Health, 33 Russell St, Toronto M5S 2S1, Canada. john_cunningham@camh.net

ABSTRACT

Background: Considerable 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/design: A 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.

Discussion: The 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 registration: ClinicalTrials.gov: NCT01429129.

Show MeSH
Related in: MedlinePlus