Objectives: The main objective was to analyze the short, medium, and long-term effectiveness of a clinical-psychological care protocol for smoking cessation using cytisinicline. Other secondary objectives were evaluate safety and whether the characteristics of smoking, adherence, and the intensity of craving and withdrawal syndrome at 4th week were associated with effectiveness,
Methods: Observational, prospective, multicenter study that includes smokers motivated to quit evaluated in twelve Smoking Cessation Services in Spain.
Results: A total of 337 smokers were studied. Effectiveness of cytisinicline was 68% at the end of treatment, but was reduced to 48.7%, 40.9% and 28.2%, at 3rd, 6th and 12th month of follow up respectively. The measurement of adherence and the intensity of craving by SRC showed statistically significant association with effectiveness at 24th week, RRadj=2.2 (p<0.001) and RRadj=0.87 (p=0.011) respectively. Common adverse effects (occurring in more than 10% of patients) were: sleep disorders, headaches, dizziness and digestive disorders.
Conclusions: The effectiveness of protocol was 68% at the end of treatment, but was reduced to 48.7%, 40.9% and 28.2% at 3rd, 6th and 12th months respectively. Subjects who met more than 80% of treatment adherence doubled their chances of success at 6th month. For each point of craving intensity, measured by the SRC, at the end of the pharmacological treatment the chances of success at 6th month were reduced by 13%. Cytisinicline was safe.
