Effect of alternative nicotine delivery systems on smoking behaviour
Research type
Research Study
Full title
A prospective randomised uncontrolled trial and online survey assessment of the effect of use alternative nicotine delivery systems on smoking reduction in a self-selecting sample of adult smokers in London, England.
IRAS ID
265692
Contact name
Neil McKeganey
Contact email
Sponsor organisation
Imperial Brands Science
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study will draw a final sample size of 300 London based adult smokers who indicate a willingness to try to reduce or quit smoking by using one of three commercially available alternative nicotine sources (myblu e-cigarette with either standard nicotine or nicotine salt e-liquid formulation, or over the counter nicotine replacement therapy (NRT)). These products will be used by adult smokers recruited by CSUR and Qualtrics. Participants will be randomly allocated to these products for a three month period. Following the three month period, study participants will be assessed at six months to identify if any change in their smoking behaviour was achieved.
To maximise naturalistic use of the devices and NRTs, participants will be allocated a Mastercard loaded with a monthly allowance with which they will purchase study products corresponding to their randomised study group. Participants will be allocated up to £36 per month after the submission of a valid proof of purchase for the three month study period. Participants will be free to choose and change the nicotine strength and, if possible, the flavour of their product.
All participants will record their cigarette consumption via online questionnaires administered at baseline (day 1), one month, two months, three months and the six-month follow up. In total, participants will receive compensation of £100 for completing all five questionnaires.
This study primarily aims to explore patterns of smoking behaviours and how adult smokers’ willingness and intent to reduce smoking varies by their ad libitum use of different nicotine products. The frequency and intensity of smokers’ cigarette consumption and the use of nicotine products will be remotely assessed via online questionnaires. Data will be analysed by stratifying important determinants including, e-liquid flavours, NRT products, nicotine strengths, patterns of use, perceived changes in health symptoms and motivation to quit.
REC name
HSC REC A
REC reference
19/NI/0118
Date of REC Opinion
3 Jul 2019
REC opinion
Further Information Favourable Opinion