Establishment of a multimodal protocol combining a motivational interview, subcutaneous injection of NicoSan® and hyper-hydration for the "stopsmoking therapy": A multicentre real-life study'.

Objectives: The StopSmoking Therapy, combins a motivational interview, a subcutaneous injection of NicoSan® and a hyperhydration protocol. The objectives were to evaluate the number of patients declaring cessation and factors related to relapse.

Methods: In the 18 months following protocol, 554 subjects who consented, responded to the study's questionnaire. Categorical variables are presented as the frequency and percentage, continuous variables are presented as the mean and standard deviation, responses of abstinent subjects and of those who had started smoking again are compared via the chi-square test for categorical variables, and the Student's t-test for continuous variables.

Results: In our sample 92.8% of the subjects reported smoking for 10 years or more. A total of 475 subjects (85.7%) reported a complete cessation (31.2% for more than 6 months and 33.1% for more than a year). Among relapsing subjects, were significantly over-represented: youngest ages, lower motivation, more frequent close friends or family using tobacco, lower dependency scores. No subject reported any significant adverse effects.

Conclusion: The multimodal protocol explored seems to have a favorable impact on smoking cessation, which could be enhanced by additional interventions dedicated to the youngest age groups, to people having smoking close friends and family, and should possibly add interventions based on cognitive behavioral therapy. A dedicated support by specialist tobacco addiction in the first weeks after treatment and/or the use of mobile support applications could also be useful. In order to asses efficacy, a prospective randomized double blind controlled versus placebo protocol could be considered.