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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Public Health 1/2015

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

BMC Public Health > Ausgabe 1/2015
Doug Fraser, Ron Borland, Coral Gartner
Wichtige Hinweise

Competing interests

All products used in this research were purchased from the manufacturer or resellers, none of whom had input into the design, data collection or analysis. The authors declare that they have no competing interests.

Authors’ contributions

CG and RB conceived the original idea for the study, sought and obtained funding. DF and CG manage the day-to-day running of the trial including the intervention and follow-ups. DF, CG, and RB wrote this manuscript. All authors read and approved the final manuscript.



Smoking 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.


Design: 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.


This trial will provide data on tobacco harm-reduction approaches and in particular the use of e-cigarettes as a replacement for smoking.

Trial registration

Australian and New Zealand Clinical Trials Registry: ACTRN12612001210​864. Date of registration: 15/11/2012.
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