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

John A Cunningham, Scott T Leatherdale, Peter L Selby, Rachel F Tyndale, Laurie Zawertailo, Vladyslav Kushnir, John A Cunningham, Scott T Leatherdale, Peter L Selby, Rachel F Tyndale, Laurie Zawertailo, Vladyslav Kushnir

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.

Figures

Figure 1
Figure 1
Overview of the proposed intervention trial.

References

    1. Canadian Cancer Society/National Cancer Institute of Canada. Canadian Cancer Statistics 2007. 2007.
    1. Baliunas D, Patra J, Rehm J, Popova S, Taylor B. Smoking-attributable morbidity: acute care hospital diagnoses and days of treatment in Canada, 2002. BMC Public Health. 2007;7:247. doi: 10.1186/1471-2458-7-247.
    1. Canadian Tobacco Use Monitoring Survey, CTUMS.
    1. U.S. Department of Health and Human Services (USDHHS) The health benefits of smoking cessation. DHHS Publication (CDC) 90-8416; 1990.
    1. Coffield AB, Maciosek MV, McGinnis JM, Harris JR, Caldwell MB, Teutsch SM, Atkins D, Richland JH, Haddix A. Priorities among recommended clinical preventive services. American Journal of Preventive Medicine. 2001;21(1):1–9. doi: 10.1016/S0749-3797(01)00308-7.
    1. Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: results of a systematic review and analysis. American Journal of Preventive Medicine. 2006;31(1):52–61. doi: 10.1016/j.amepre.2006.03.012.
    1. Warner KE, Mendez D, Smith DG. The financial implications of coverage of smoking cessation treatment by managed care organizations. Inquiry. 2004;41(1):57–69. doi: 10.5034/inquiryjrnl_41.1.57.
    1. Woolacott NF, Jones L, Forbes CA, Mather LC, Sowden AJ, Song FJ, Raftery JP, Aveyard PN, Hyde CJ, Barton PM. The clinical effectiveness and cost-effectiveness of bupropion and nicotine replacement therapy for smoking cessation: a systematic review and economic evaluation. Health Technol Assess. 2002;6(16):1–245.
    1. Giardina TD, Hyland A, Bauer UE, Cummings KM. Which population-based interventions would motivate smokers to think seriously about stopping smoking? American Journal of Health Promotion. 2004;18(6):405–408.
    1. Cunningham JA, Selby PL. Intentions of smokers to use free nicotine replacement therapy. Canadian Medical Association Journal. 2008;179(2):145–146. doi: 10.1503/cmaj.071241.
    1. Cummings KM, Fix B, Celestino P, Carlin-Menter S, O'Connor R, Hyland A. Reach, efficacy, and cost-effectiveness of free nicotine medication giveaway programs. J Public Health Manag Pract. 2006;12(1):37–43.
    1. Selby P, Zawertailo L, Dragonetti R. The STOP (STOP Smoking Treatment for Ontario Patients) Study 6-month effectiveness of mass distribution of NRT in Ontario. Interim Progress Report to the Ministry of Health Promotion. (personal communication) 2006.
    1. Lerman C, Tyndale R, Patterson F, Wileyto EP, Shields PG, Pinto A, Benowitz N. Nicotine metabolite ratio predicts efficacy of transdermal nicotine for smoking cessation. Clin Pharmacol Ther. 2006;79(6):600–608. doi: 10.1016/j.clpt.2006.02.006.
    1. Etter JF, Perneger TV, Ronchi A. Collecting saliva samples by mail. American Journal of Epidemiology. 1998;147(2):141–146.
    1. Etter JF, Neidhart E, Bertrand S, Malafosse A, Bertrand D. Collecting saliva by mail for genetic and cotinine analyses in participants recruited through the Internet. European Journal of Epidemiology. 2005;20(10):833–838. doi: 10.1007/s10654-005-2148-7.
    1. Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Systematic Review. 2008. p. CD000146.
    1. Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010;10:181. doi: 10.1186/1471-2458-10-181.
    1. Cummings KM, Hyland A, Carlin-Menter S, Mahoney MC, Willett J, Juster HR. Costs of giving out free nicotine patches through a telephone quit line. J Public Health Manag Pract. 2011;17(3):E16–23.
    1. McAfee TA, Bush T, Deprey TM, Mahoney LD, Zbikowski SM, Fellows JL, McClure JB. Nicotine patches and uninsured quitline callers. A randomized trial of two versus eight weeks. Am J Prev Med. 2008;35(2):103–110. doi: 10.1016/j.amepre.2008.04.017.
    1. Campbell SL, Lee L, Haugland C, Helgerson SD, Harwell TS. Tobacco quitline use: enhancing benefit and increasing abstinence. Am J Prev Med. 2008;35(4):386–388. doi: 10.1016/j.amepre.2008.06.032.
    1. Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict. 1989;84(7):791–799. doi: 10.1111/j.1360-0443.1989.tb03059.x.
    1. Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998;158(16):1789–1795. doi: 10.1001/archinte.158.16.1789.
    1. Willers S, Axmon A, Feyerabend C, Nielsen J, Skarping G, Skerfving S. Assessment of environmental tobacco smoke exposure in children with asthmatic symptoms by questionnaire and cotinine concentrations in plasma, saliva, and urine. Journal of Clinical Epidemiology. 2000;53(7):715–721. doi: 10.1016/S0895-4356(99)00212-7.
    1. Binnie V, McHugh S, Macpherson L, Borland B, Moir K, Malik K. The validation of self-reported smoking status by analysing cotinine levels in stimulated and unstimulated saliva, serum and urine. Oral Diseases. 2004;10(5):287–293. doi: 10.1111/j.1601-0825.2004.01018.x.
    1. Simoni M, Baldacci S, Puntoni R, Pistelli F, Farchi S, Lo Presti E, Pistelli R, Corbo G, Agabiti N, Basso S. et al.Plasma, salivary and urinary cotinine in non-smoker Italian women exposed and unexposed to environmental tobacco smoking (SEASD study) Clinical Chemistry and Laboratory Medicine. 2006;44(5):632–638. doi: 10.1515/CCLM.2006.098.
    1. 2008 PHS Guideline Update Panel. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respiratory Care. 2008;53:1217–1222.
    1. Fleiss JL. Statistican Methods for Rates and Proportions. 2. New York: John Wiley and Sons; 1981.
    1. Cunningham JA, Koski-Jännes A, Wild TC, Cordingley J. Treating alcohol problems with self-help materials: A population study. Journal of Studies on Alcohol. 2002;63:649–654.
    1. Cunningham JA, Wild TC, Cordingley J, van Mierlo T, Humphreys K. Twelve month follow-up results from a randomized controlled trial of a brief personalized feedback intervention for problem drinkers. Alcohol and Alcoholism. in press .
    1. Victor JC, Diemert LM. Longitudinal surveys and attrition: Issues and solutions. Tobacco Control for the 21st Century: Challenges in Research and Evaluation: 2008; Toronto, Ontario. 2008.

Source: PubMed

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