Caponnetto 2013b.
Study characteristics | ||
Methods | Design: Prospective cohort Recruitment and setting: Inpatients at a psychiatric institution in Italy Study start date/end date: Not specified |
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Participants | Total N: 14 Inclusion criteria:
Exclusion criteria:
57% women, mean age 44.6 (SD 12.5), mean pack years smoked 28.8 (SD 12.9) Motivated to quit: Not specified E cigarette use at baseline: Not specified |
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Interventions |
EC: Cig‐a‐like Seen at baseline, given EC ('Categoria' brand) with an initial 4‐week supply of 7.4 mg nicotine cartridges. Instructed to use ad libitum up to 4 cartridges a day. EC cartridges supplied at months 1, 2, and 3 No instruction on cessation or reduction was provided. |
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Outcomes | Follow‐up at 1, 2, 3, 6 and 12 months where cigarette consumption, CO, AEs and positive and negative symptoms of schizophrenia were measured Sustained reduction of ≥ 50% for at least 30 days at 12 months 30‐day point prevalence CO‐validated abstinence at 12 months Adverse events |
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Study funding | "We wish to thank Arbi Group Srl (Milano, Italy) for the free supplies of “Categoria” e‐cigarette kits and nicotine cartridges as well as their support. We would also like to thank LIAF (Lega Italiana AntiFumo) for the collaboration." | |
Author declarations | "Pasquale Caponnetto, Roberta Auditore, Cristina Russo and Giorgio Carlo Cappello declare no conflict of interest. Riccardo Polosa 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 (Milano, Italy), the distributor of the CategoriaTM e‐cigarette." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Prospective cohort; no randomization |
Allocation concealment (selection bias) | High risk | Not randomized |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 0/14 lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Unable to determine prespecified outcomes |