None listed
Conditions
Brief summary
This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness and cost-effectiveness of 8 weeks of treatment with a vaporised nicotine product (VNP) and liquid nicotine compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.
Interventions
Vaporised nicotine product (VNP) containing e-liquid nicotine (18mg/ml nicotine) for 8 weeks plus Quitline behavioural support.
The VNP used is the Innokin Endura T18 Personal Vaporizer, which has a refill-able 2.5ml tank for the e-liquid. The e-liquid will be provided in 10ml dropper bottles with childproof caps and three flavours will be offered to participants tobacco (containing nicotine (18mg/ml), vegetable glycerol (25mg/ml), propylene glycol (73mg/ml) and flavouring (1mg/ml)), strawberry
Vaporised nicotine product (VNP) containing e-liquid nicotine (18mg/ml nicotine) for 8 weeks plus Quitline behavioural support. The VNP used is the Innokin Endura T18 Personal Vaporizer, which has a refill-able 2.5ml tank for the e-liquid. The e-liquid will be provided in 10ml dropper bottles with childproof caps and three flavours will be offered to participants tobacco (containing nicotine (18mg/ml), vegetable glycerol (25mg/ml), propylene glycol (73mg/ml) and flavouring (1mg/ml)), strawberry (containing nicotine (18mg/ml), vegetable glycerol (33mg/ml), propylene glycol (71mg/ml) and flavouring (0.6mg/ml)) and menthol (containing nicotine (18mg/ml), vegetable glycerol (23mg/ml), propylene glycol (71mg/ml) and flavouring (2mg/ml)). Participants are 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. Adherence will be monitored via weekly text message surveys and in 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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be 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; and willing to complete two 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 will be excluded from this trial, as will current users of smoking cessation medications (i.e., NRT, buproprion [Zyban], clonidine, nortriptyline, electronic nicotine cigarettes ), or 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 three months: serious chronic lung diseases, arrhythmia, heart attack, stroke, or severe angina.
Outcome results
None listed