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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

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
Participants Total N: 14
Inclusion criteria:
  • Smoked ≥ 20 cpd for at least the past 10 years

  • Diagnosis of schizophrenia


Exclusion criteria:
  • Alcohol and illicit drug use

  • Recent myocardial infarction

  • Angina pectoris

  • High blood pressure (BP > 140 mmHg systolic or 90 mmHg diastolic, or both)

  • Diabetes mellitus

  • Severe allergies

  • Poorly‐controlled asthma or other airway diseases

  • Inclusion based on specific population characteristic: Diagnosis of schizophrenia


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
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.
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
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