Caponnetto 2013a.
| Study characteristics | ||
| Methods | Design: 3‐arm double‐blind randomized controlled trial: EC with 7.2 mg nicotine for 12 weeks; same for 6 weeks followed by 5.2 mg for 6 weeks: EC with no nicotine for 12 weeks Recruitment: Newspaper advertisements Setting: Outpatient clinic, Italy Study start date: April 2010; Study end date:April 2012 |
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| Participants | Total N: 300 Inclusion criteria: smoked ≥ 10 cpd for past 5 years; age 18‐70; in good health; not currently or intending to quit smoking in the next 30 days. Exclusion criteria: symptomatic cardiovascular or respiratory disease; regular psychotropic medicine use; current or past history of alcohol abuse; use of smokeless tobacco or NRT; pregnancy or breastfeeding. 36% women, mean age 44 (SD 12.5), mean cpd 20 (IQR: 15‐25) Not currently or intending to quit smoking in the next 30 days E cigarette use at baseline: Not specified |
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| Interventions |
EC: Cig‐a‐like EC presented as a healthier alternative to tobacco smoke and could be freely used, ad libitum (up to 4 cartridges a day) for 12 weeks, as a tobacco substitute EC used: 'Categoria' (model 401) with disposable cartridges
Baseline visit and up to 7 follow‐up visits to receive more cartridges, hand‐in diaries, measure CO and vital signs |
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| Outcomes | Abstinence at 12 months (complete self‐reported abstinence from tobacco smoking since previous visit at 6 months, confirmed with CO < 7 ppm at 12 months) ≥ 50% reduction in baseline cigarettes at 12 months Recorded AEs thought to be related to tobacco smoking and EC at baseline and at each study visit (7 follow‐up visits over 12 weeks, plus at 24 and 52 weeks) |
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| Study funding | "This research was supported by a grant‐in‐aid from Lega Italiana AntiFumo. The study sponsor had no involvement in the study design, collection, analysis, and interpretation of data, the writing of the manuscript or the decision to submit the manuscript for publication. RP and PC are currently funded by the University of Catania, Italy. The e‐cigarette supplier had no involvement in the study design, collection, analysis, and interpretation of data, the writing of the manuscript or the decision to submit the manuscript for publication." | |
| Author declarations | "RP has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has served as a consultant for Pfizer and Arbi Group Srl, the distributor of the CategoriaTM e‐Cigarette. The other authors have no relevant conflict of interest to declare in relation to this work." | |
| Notes | Additional data provided from authors | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated, block size 15 (5:5:5 ratio) |
| Allocation concealment (selection bias) | Low risk | Randomization carried out by pharmacy, who did not have direct contact with the participants |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind. Quote: “Blinding was ensured by the identical external appearance of the cartridges. The hospital pharmacy was in charge of randomization and packaging of the cigarettes” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 211 (70.3%) and 183 (61%) attended 6‐ and 12‐month follow‐up (at 12 m, 35% lost in 7.2 group; 37% lost in 5.4 group; 45% lost in no‐nicotine group) |
| Selective reporting (reporting bias) | Unclear risk | Unclear if original intention was to combine groups A+B or not. In sample size calculation they compared A+B with C, but results are not always reported in this way |