Protocol for a randomised pragmatic policy trial of nicotine products for quitting or long-term substitution in smokers

BMC Public Health

Study Protocol

Doug Fraser¹  Coral Gartner²  Ron Borland³ 

[1] School of Public Health, The University of Queensland, Brisbane, Australia;School of Public Health, The University of Queensland, Brisbane, Australia;The University of Queensland Centre for Clinical Research, Brisbane, Australia;The Cancer Council Victoria, Melbourne, Australia;The University of Queensland Centre for Clinical Research, Brisbane, Australia;

关键词: E-cigarettes;    Nicotine;    Pragmatic trial;    Randomized controlled trial;    Harm-reduction;    Smoking;   

DOI  :  10.1186/s12889-015-2366-1

 received in 2015-09-18, accepted in 2015-09-29,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundSmoking is Australia’s leading preventable cause of premature mortality and a major contributor to the national disease burden. If quit rates do not dramatically improve, then smoking will continue to be a major public health issue for decades to come. Harm-reduction approaches using novel nicotine products like e-cigarettes as long term replacements for smoking have the potential to improve quit rates. However, little research has assessed such approaches.Methods/DesignDesign: Three-arm parallel-group pragmatic randomised controlled trial.Participants: People living in Australia who are at least 18 years old, smoke five or more cigarettes per day and are willing to try a sample of nicotine products.Intervention: Participants are randomised to receive standard quit advice and medicinal nicotine (Condition A); quit or substitute advice and medicinal nicotine (Condition B); or quit or substitute advice and medicinal nicotine and e-cigarettes (Condition C). Participants choose which (if any) nicotine products to receive to try in a free sample pack followed by a two to three week free supply of their favourite product(s) and the option to purchase more at a discounted price. Follow-up surveys will assess nicotine product use and smoking.Primary outcome: Continuous abstinence for at least 6 months.Target sample size: 1600 people (Condition A: 340; Condition B: 630; Condition C: 630) provides at least 80 % power at p = 0.05 to detect a 5 % difference in abstinence rates between each condition.DiscussionThis trial will provide data on tobacco harm-reduction approaches and in particular the use of e-cigarettes as a replacement for smoking.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12612001210864. Date of registration: 15/11/2012.

【 授权许可】

CC BY   
© Fraser et al. 2015