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Clinical Trial Summary

A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.


Clinical Trial Description

A pragmatic, double-blind, three-arm randomised controlled trial undertaken in New Zealand to determine whether e-cigarettes combined with nicotine patches can assist smokers in remaining abstinent for at least six months. 1809 smokers who are motivated to quit will be recruited from the community using media advertising and randomly allocated to one of three groups, namely 1) 21mg nicotine patch daily, 2) 21mg nicotine patch daily plus a 'new generation' e-cigarette with no nicotine or 3) 21mg nicotine patch daily plus a 'new generation' e-cigarettes with nicotine. Participants will be instructed to start using the study products two weeks prior to their quit date, and continue for a further 12 weeks after their quit date. Participants will also receive a cessation behavioural support programme consisting of at least six follow-up telephone calls (10-15 minutes each) over the first six weeks. Outcome data will be collected on the participant's set quit date, then one, three, six and (for some but not all) 12 months post-quit date. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02521662
Study type Interventional
Source University of Auckland, New Zealand
Contact
Status Completed
Phase Phase 3
Start date March 2016
Completion date August 2018

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