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Research Article Open Access
Introduction: The published data suggest that interventions which combine pharmacotherapy and behavioural support increase success rates of smoking cessation compared to minimal intervention or usual care; however, a standardized behavioural psychotherapy programme has not been assessed yet. Our main aim was to assess if socio-demographic and housing characteristics of smokers attending an Italian smoking cessation centre, could have influenced the choice between varenicline therapy and psychological support only. Our secondary aims were: i) to evaluate the 6-month abstinence rates (ARs), confirmed by comparing exhaled air carbon monoxide concentrations, in smokers according to whether they took varenicline or received only psychological support; ii) to assess the most frequently reported adverse drug reactions (ADRs) by the varenicline group, mainly focusing on psychiatric events; iii) to evaluate the differences between men and women with regard to specific varenicline-related ADRs
Method: 142 smokers were enrolled; all of them received the same psychological support programme. They were evaluated by a team of clinical experts, who advised them to opt for either one quitting method or the other; then the smokers chose themselves a treatment option of either varenicline plus psychotherapy (VAR: 78 patients) or psychotherapy alone (PSY: 64 patients).
Results: Socio-demographic and psychological characteristics of patients have significantly influenced the treatment choice; the 6-month ARs were 35.9% versus 10.9% (p<0.01) in those using varenicline versus psychotherapy, respectively; 57.7% of the patients reported at least one adverse event.
Conclusion: The analysis of socio-demographic factors and psychological characteristics of patients seems to be necessary to offer them the most effective therapy in order to achieve good abstinence rates. Therefore, this study confirms the data about the efficacy and safety of varenicline. Our screening methods and exclusion criteria seem to be valid aids to achieving good therapeutic outcomes with a low risk of occurrence of severe psychiatric events.
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Author(s): Silvia Leone3*, Roberto Carrozzino1,2, Monica Tassistro1,2, Luigi Robbiano3, Maria Laura Zuccoli3, Francesca Romani, Antonietta Martelli3 and Francesca Mattioli3
Varenicline, Socio-demographic features, Smoking cessation Cognitive behavioural psychotherapy, Adverse events, Clinical Research Studies, Clinical drug trials