ACTRN12617001324303.

Study name	Vaporised nicotine products versus oral forms of nicotine replacement therapy (NRT) products for tobacco smoking cessation among low‐socioeconomic status (low‐SES) people who smoke
Methods	Parallel, single‐blinded, randomized controlled trial Setting: Australia Recruitment: Not stated.
Participants	Target sample size: 868 Inclusion criteria: At least 18 years of age Current daily smoker Motivated and willing to make a quit attempt using medications (NRT/VNP) Speak English Able to provide verbal informed consent Receipt of government pension or allowance (proxy for low‐SES) Have a phone we contact them on; Willing to complete 2 telephone check‐in calls and baseline and follow‐up telephone interviews The term “current smoker” in this trial will refer to those who use either factory‐made or roll‐own cigarettes. Exclusion criteria: Women who are pregnant, breastfeeding or planning to become pregnant in the next 12 months Current users of smoking cessation medications (i.e. NRT, bupropion [Zyban], clonidine, nortriptyline, electronic nicotine cigarettes ) Those who are participating in another smoking cessation program or study People will also be excluded if they report any of the following medical conditions in the previous 3 months: serious chronic lung diseases, arrhythmia, heart attack, stroke, or severe angina
Interventions	Vaporised nicotine product (VNP) arm: Innokin Endura T18 Personal Vaporizer e‐liquid nicotine (18mg/ml nicotine) for 8 weeks Quitline behavioral support 3 flavors will be offered: tobacco, strawberry, menthol Permitted to use the study product ad libitum throughout the day and encouraged to stop smoking completely, or reduce smoking if unable to stop completely Participants will be provided with detailed instructions on how to use the e‐cigarette device effectively Oral nicotine replacement therapy (NRT) arm: 2 mg or 4 mg nicotine gum/lozenge for 8 weeks Quitline behavioral support Those receiving the lozenge will be instructed to use 9 ‐ 15 lozenges per day, approximately 1 every 2 hours or when they have an urge to smoke Those receiving the gum will be instructed to use 10 to 20 pieces per day for the 2 mg gum and 4 to 10 pieces per day for the 4 mg gum, approximately 1 every 2 hours or when they have an urge to smoke Participants will be provided with detailed instructions on how to use the NRT effectively and encouraged to stop smoking completely, or reduce smoking if unable to stop completely
Outcomes	Primary outcome: Carbon monoxide‐verified six‐month continuous abstinence (smoking not more than 5 cigarettes) from the quit date (8 months from baseline) Secondary outcomes measured at 2‐week and 6‐week check‐in calls and 8‐month follow‐up Self‐reported 7‐day point prevalence abstinence Self‐reported continuous abstinence: defined as self‐report of smoking not more than 5 cigarettes from the designated quit date Self‐reported number of cpd among people continuing to smoke Self‐reported 30‐day PPA at each follow‐up (self‐report of having smoked no cigarettes (not even a puff)) Mean reduction in number of cigarettes smoked per day based on participant self‐report Proportion of participants that achieved a 50% reduction of baseline cigarette consumption based on participant self‐report (8 months only) Self‐reported continued use of nicotine products to assess maintenance use and dual use (8 months only) Weekly text message surveys and check‐in calls 2 weeks and 6 weeks into the treatment period. These check‐in calls will also assess smoking status, short‐term outcomes, and adverse events at these time points
Starting date	Anticipated start date: 30 April 2019
Contact information	Richard P Mattick, r.mattick@unsw.edu.au Alexandra Aiken, a.aiken@unsw.edu.au
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