Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

PMCID: PMC3602285This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

Nicotine absorption from e-cigarettes over 12 months

Background Research indicates that, over time, exclusive e-cigarette users (vapers) gradually reduce the nicotine concentration in their e-liquid and transition to more sophisticated devices. Alongside this, consumption of e-liquid increases and constant cotinine levels are maintained. Aims We aimed to confirm these observations in 27 experienced vapers tested at baseline and 12 months later, by measuring nicotine absorption (via salivary levels of the nicotine metabolite cotinine; ng/mL), nicotine concentrations in e-liquid (mg/mL), volume of e-liquid consumed (mL per day), device types and flavours used, both at baseline and 12 months. Results Vapers reduced both their nicotine concentrations in e-liquid over 12 months (from 13.83 mg/mL at baseline to 9.91 at follow up) but significantly increased their e-liquid consumption (from 4.44 to 6.84 mL). No significant changes in salivary cotinine concentrations (370.88 ng/mL at baseline and 415.78 ng/mL at follow up) were observed. There was an increase in sub-ohming (using an atomiser coil with resistance of <1 Ω with increased power) at 12 months, and in the use of fruit flavoured e-liquids. Conclusions Our sample of experienced vapers reduced the concentration of nicotine in their e-liquid over time, but maintained their nicotine intake possibly through self-titration via more intensive puffing. Findings suggest there may be little benefit in reducing nicotine e-liquid concentration since this appears to result in higher e-liquid consumption which may incur both a financial and health cost. Gaining an understanding of underlying reasons for lowering e-liquid concentration would be a useful line of empirical enquiry

Changing Behaviour: Electronic Cigarettes

Smoking is one of the largest causes of death and disease in the developed world, responsible for 96,000 deaths per year in the UK1. If current trends continue, it is estimated that globally, a billion lives will be lost to smoking-related diseases by the end of the 21st Century2. This briefing summarises the facts and figures around smoking cessation and the use of e-cigarettes for behaviour change in adults followed by public policy recommendations to facilitate smoking cessation

The time course of compensatory puffing with an electronic cigarette: Secondary analysis of real-world puffing data with high and low nicotine concentration under fixed and adjustable power settings

Introduction: In a secondary analysis of our published data demonstrating compensatory vaping behavior (increased puff number, puff duration, and device power) with e-cigarettes refilled with low versus high nicotine concentration e-liquid, here we examine 5-day time course over which compensatory behavior occurs under fixed and adjustable power settings. Aims and Methods: Nineteen experienced vapers (37.90 ± 10.66 years, eight females) vaped ad libitum for 5 consecutive days under four counterbalanced conditions (ie, 20 days in total): (1) low nicotine (6 mg/mL)/fixed power (4.0 V/10 W); (2) low nicotine/adjustable power; (3) high nicotine (18 mg/mL)/fixed power; (4) high nicotine/adjustable power (at 1.6 Ohm). Puff number, puff duration, and power settings were recorded by the device. For each day, total daily puffing time was calculated by multiplying daily puff number by mean daily puff duration. Results: A significant day × setting interaction revealed that whilst puffing compensation (daily puffing time) continued to increase over 5 days under fixed power, it remained stable when power settings were adjustable. Separate analysis for puff number and puff duration suggested that the puffing compensatory behavior was largely maintained via longer puff duration. Conclusions: Under fixed power conditions (4.0 V/10 W), vapers appear to compensate for poor nicotine delivery by taking longer puffs and this compensatory puffing appears to be maintained over time. Implications: Studies in smokers suggest that when switching to lower nicotine levels, compensation for poorer nicotine delivery is transient. Our novel findings suggest that vapers show a different pattern of compensation which is influenced by both nicotine strength and device power settings. When power is fixed (4.0 V; 10 W), compensation (via more intensive puffing) appears prolonged, persisting up to 5 days. Under adjustable settings when power is increased, puffing patterns remain stable over time. Implications of such compensatory behaviors for product safety and user satisfaction need further exploration

Daily exposure to formaldehyde and acetaldehyde and potential health risk associated with use of high and low nicotine e-liquid concentrations

Recent evidence suggests that e-cigarette users tend to change their puffing behaviors when using e-liquids with reduced nicotine concentrations by taking longer and more frequent puffs. Using puffing regimens modelled on puffing topography data from 19 experienced e-cigarette users who switched between 18 and 6 mg/mL e-liquids with and without power adjustments, differences in daily exposure to carbonyl compounds and estimated changes in cancer risk were assessed by production of aerosols generated using a smoking machine and analyzed using gas and liquid chromatography. Significant differences across conditions were found for formaldehyde and acetaldehyde (p<0.01). Switching from a higher to a lower nicotine concentration was associated with greater exposure regardless of whether power settings were fixed or adjustable which is likely due to increased liquid consumption under lower nicotine concentration settings. Daily exposure for formaldehyde and acetaldehyde was higher for 17/19 participants when using low (6mg/mL) compared with high (18mg/mL) nicotine e-liquid concentration when power was fixed. When power adjustments were permitted, formaldehyde and acetaldehyde levels were higher respectively for 16/19 and 14/19 participants with the use of 6 compared with 18 mg/mL nicotine e-liquid

Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

E‐cigarette support for smoking cessation: Identifying the effectiveness of intervention components in an on‐line randomized optimization experiment

Aims, Design and Setting The aim of this study was to determine which combination(s) of five e-cigarette-orientated intervention components, delivered on-line, affect smoking cessation. An on-line (UK) balanced five-factor (2 × 2 × 2 × 2 × 2 = 32 intervention combinations) randomized factorial design guided by the multi-phase optimization strategy (MOST) was used. Participants A total of 1214 eligible participants (61% female; 97% white) were recruited via social media. Interventions The five on-line intervention components designed to help smokers switch to exclusive e-cigarette use were: (1) tailored device selection advice; (2) tailored e-liquid nicotine strength advice; (3): tailored e-liquid flavour advice; (4) brief information on relative harms; and (5) text message (SMS) support. Measurements The primary outcome was 4-week self-reported complete abstinence at 12 weeks post-randomization. Primary analyses were intention-to-treat (loss to follow-up recorded as smoking). Logistic regressions modelled the three- and two-way interactions and main effects, explored in that order. Findings In the adjusted model the only significant interaction was a two-way interaction, advice on flavour combined with text message support, which increased the odds of abstinence (odds ratio = 1.55, 95% confidence interval = 1.13–2.14, P = 0.007, Bayes factor = 7.25). There were no main effects of the intervention components. Conclusions Text-message support with tailored advice on flavour is a promising intervention combination for smokers using an e-cigarette in a quit attempt

Tailored interventions to assist smokers to stop smoking using e-cigarettes (TASSE): Study protocol [version 3]

Background: T here is increasing evidence that e-cigarettes (EC) are an effective smoking cessation aid when combined with behavioural support. T here is further evidence for digital tailored interventions as cost effective approaches that can increase smoking cessation rates. Experimental work also suggests the addition of a ‘nicotine fact sheet’ can improve smokers’ risk perceptions related to EC. However, multifaceted approaches to deliver ‘tailored advice’ for smoking cessation combining various key evidenced based components are lacking. T he aim of this study is to use a Multiphase Optimisation Strategy (MOST ) to determine which of five, or a combination thereof, EC-orientated intervention components is associated with self-reported cessation over the previous 4-weeks at 12-week follow-up. Methods/Design: T his online study will utilise a 2x2x2x2x2 factorial design resulting in 32 experimental conditions. T he five intervention components will be: 1: tailored advice on EC device; 2: tailored advice on e-liquid nicotine strength; 3: tailored advice on eliquid flavour; 4: e-cigarette written information; 5: text message support. A sample of N=1184 adult, UK resident smokers will be randomly allocated to one of the 32 conditions, which will be permutations of the 5 components (counter-balanced). T he primary outcome is 4 weeks of self-reported complete abstinence at 12 weeks post randomisation. Secondary outcomes are 7-day point prevalence, 50% reduction in baseline cigarettes smoked per day, time to switch and adherence to recommendation. T he primary analysis will be by intent-to-treat with the assumption that missing equals smoking. Logistic regression will be used to model the five main effects and the ten 2x2 interactions. A number of secondary analyses will also be conducted including models adjusting for demographic and smoking indices and including only those who received the intervention. Discussion: T o date, components that assist quitting by use of EC or other aids have largely been studied in isolation. T his study presents the first attempt to combine evidenced based interventions, using the MOST method, to test which components are associated with quitting. T he findings will be used to inform which components to include and their estimated effect sizes for a definitive randomised controlled trial (RCT ) to examine the efficacy of the intervention compared with usual care (own choice and no support)

Magazine and reader constructions of 'metrosexuality' and masculinity: a membership categorisation analysis

Since the launch of men's lifestyle magazines in the 1980s, academic literature has predominantly focused on them as a cultural phenomenon arising from entrepreneurial and commercial initiatives and/or as cultural texts that proffer representations of masculinity such as 'new lad' and 'new dad'. This paper steps aside from the focus on culture and, instead, treats magazine content as a discursive space in which gender and sexuality are oriented to, negotiated, and accomplished within and beyond the magazine itself (i.e. through readers' responses). Specifically, membership categorisation analysis is deployed to explore how the relatively new (and perhaps alternative) category for men - 'metrosexual' - is presented and received. Our analysis suggests that masculinity concerns are central in debates about 'metrosexuality', with self-identified 'metrosexuals' invoking heterosexual prowess and self-respect on the one hand, and critics (e.g. selfidentified 'real men') lamenting 'metrosexuality' for its perceived effeminacy and lack of authenticity on the other. Implications for understanding contemporary masculinities are discussed

Academic motherhood and fieldwork: Juggling time, emotions and competing demands

The idea and practice of going ‘into the field’ to conduct research and gather data is a deeply rooted aspect of Geography as a discipline. For global North Development Geographers, amongst others, this usually entails travelling to, and spending periods of time in, often far-flung parts of the global South. Forging a successful academic career as a Development Geographer in the UK, is therefore to some extent predicated on mobility. This paper aims to critically engage with the gendered aspects of this expected mobility, focusing on the challenges and time constraints that are apparent when conducting overseas fieldwork as a mother, unaccompanied by her children. The paper emphasises the emotion work that is entailed in balancing the competing demands of overseas fieldwork and mothering, and begins to think through the implications of these challenges in terms of the types of knowledge we produce, as well as in relation to gender equality within the academy