title: Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.
abstract: BACKGROUND
  It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.
  
  
  METHODS
  
  
  
  METHODS
  We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.
  
  
  METHODS
  A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".
  
  
  METHODS
  The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test.
  
  
  CONCLUSIONS
  The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01979796.
authors.affiliation: Smoking Prevention/Cessation Centre, A,O,U, Policlinico-V,Emanuele, Department of Clinical and Molecular Biomedicine, University of Catania, Catania, Italy. p.caponnetto@unict.it.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Caponnetto
authors.forename: Riccardo
authors.initials: R
authors.lastname: Polosa
authors.forename: Roberta
authors.initials: R
authors.lastname: Auditore
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Minutolo
authors.forename: Maria
authors.initials: M
authors.lastname: Signorelli
authors.forename: Marilena
authors.initials: M
authors.lastname: Maglia
authors.forename: Angela
authors.initials: A
authors.lastname: Alamo
authors.forename: Filippo
authors.initials: F
authors.lastname: Palermo
authors.forename: Eugenio
authors.initials: E
authors.lastname: Aguglia
mesh_terms: D000280:Administration, Inhalation; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002985:Clinical Protocols; D003071:Cognition; D004581:Electronics; D004867:Equipment Design; D006801:Humans; D007558:Italy; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D010465:Perception; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D012559:Schizophrenia / Q000150:complications* / Q000175:diagnosis; D012565:Schizophrenic Psychology; D012907:Smoking / Q000009:adverse effects / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires; D013997:Time Factors; D061485:Tobacco Use Cessation Devices / Q000009:adverse effects; D014029:Tobacco Use Disorder / Q000150:complications / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D014835:Volatilization
chemical_list: D018722:Nicotinic Agonists; D009538:Nicotine