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

Fraser, Doug, Borland, Ron and Gartner, Coral (2015) Protocol for a randomised pragmatic policy trial of nicotine products for quitting or long-term substitution in smokers. BMC Public Health, 15 1: 1026.1-1026.9. doi:10.1186/s12889-015-2366-1


Author Fraser, Doug
Borland, Ron
Gartner, Coral
Title Protocol for a randomised pragmatic policy trial of nicotine products for quitting or long-term substitution in smokers
Journal name BMC Public Health   Check publisher's open access policy
ISSN 1471-2458
Publication date 2015-10-06
Sub-type Other
DOI 10.1186/s12889-015-2366-1
Open Access Status DOI
Volume 15
Issue 1
Start page 1026.1
End page 1026.9
Total pages 9
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2016
Language eng
Formatted 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/Design: 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.

Discussion: 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: ACTRN12612001210864. Date of registration: 15/11/2012
Keyword E-cigarettes
Nicotine
Pragmatic trial
Randomized controlled trial
Harm-reduction
Smoking
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Other
Collections: UQ Centre for Clinical Research Publications
Non HERDC
School of Public Health Publications
 
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Created: Sat, 10 Oct 2015, 08:25:04 EST by Coral Gartner on behalf of School of Public Health