NCT02521662

Trial name or title	A randomized‐controlled clinical trial to evaluate the effectiveness and safety of combining nicotine patches with e‐cigarettes (with and without nicotine) plus behavioural support, on smoking abstinence
Methods	Randomized parallel‐assignment double‐blind trial Setting: community, New Zealand Recruitment: volunteers
Participants	Estimated enrolment: 1809 Inclusion criteria: Smoke and want to quit in the next 3 months At least 18 years of age Are prepared to use a nicotine patch or a nicotine patch and EC together Exclude if: pregnant women women who are breastfeeding current users of NRT products people currently enrolled in another smoking cessation programme or other cessation study people who have used an EC for more than 1 week in the last year for smoking cessation current users of non‐nicotine‐based cessation therapies (e.g. bupropion, clonidine, nortriptyline or varenicline) people who have had a heart attack, stroke or severe angina within the previous 2 weeks people who self‐report a history of severe allergies and/or poorly controlled asthma
Interventions	All participants will receive withdrawal‐oriented behavioural support for 6 weeks post‐quit 1) Nicotine patch for 14 weeks including 2 week prequit 2) Nicotine patch and nicotine‐free EC for 14 weeks 3) Nicotine patch and nicotine EC for 14 weeks
Outcomes	Primary: Continuous abstinence at 6 months with CO validation Secondary: Self‐reported continuous abstinence, PP abstinence, number of cigs, smoking reduction, time to relapse, withdrawal, self‐efficacy, use of other cessation methods/products, compliance, dual use, serious adverse events, opinions
Starting date	March 2015
Contact information	Natalie Walker
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