title: Protocol for a randomised pragmatic policy trial of nicotine products for quitting or long-term substitution in smokers.
abstract: BACKGROUND
  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.
  
  
  METHODS
  
  
  
  METHODS
  Three-arm parallel-group pragmatic randomised controlled trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  This trial will provide data on tobacco harm-reduction approaches and in particular the use of e-cigarettes as a replacement for smoking.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry: ACTRN12612001210864. Date of registration: 15/11/2012.
authors.affiliation: School of Public Health, The University of Queensland, Brisbane, Australia. d.fraser2@uq.edu.au.
authors.forename: Doug
authors.initials: D
authors.lastname: Fraser
authors.affiliation: The Cancer Council Victoria, Melbourne, Australia. ron.borland@cancervic.org.au.|The University of Queensland Centre for Clinical Research, Brisbane, Australia. ron.borland@cancervic.org.au.
authors.forename: Ron
authors.initials: R
authors.lastname: Borland
authors.affiliation: School of Public Health, The University of Queensland, Brisbane, Australia. c.gartner@uq.edu.au.|The University of Queensland Centre for Clinical Research, Brisbane, Australia. c.gartner@uq.edu.au.
authors.forename: Coral
authors.initials: C
authors.lastname: Gartner
mesh_terms: D001315:Australia; D066300:Electronic Nicotine Delivery Systems; D006801:Humans; D009520:New Zealand; D009538:Nicotine; D057766:Policy; D012107:Research Design; D018401:Sample Size; D016540:Smoking Cessation / Q000379:methods*; D011795:Surveys and Questionnaires; D061485:Tobacco Use Cessation Devices
chemical_list: D009538:Nicotine