Study Protocol for a Randomized Controlled Trial of Electronic Cigarettes versus Nicotine Patch
Wednesday, April 10, 2013
Posted by: Natalia Gromov
Bullen C, Williman J, Howe C, Laugesen M, McRobbie H, Parag V, Walker N. BMC Public Health. 2013 Mar 8;13:210.
This paper outlines the protocol for a randomized trial testing the relative effectiveness of using electronic cigarettes versus nicotine patch to quit smoking. The study design is a parallel group, 3-arm randomized controlled trial. Participants will be adults living in Auckland, NZ who want to quit smoking. The three study arms are 1) Elusion e-cigarettes with nicotine cartridges, 2) Elusion e-cigarettes with placebo cartridges (no nicotine), or 3) nicotine patch alone. All participants will be told to use their quit aid for one week prior and 12 weeks after quitting, daily. All participants will also be offered behavioral support through the New Zealand quitline. The authors state that the trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, e-cigarettes could help many smokers as an alternative smoking cessation aid to standard nicotine replacement products.
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