Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
Cigarette smoking is one of the major health problems in the modern world for the impact on
morbidity and mortality with devastating effects on cardio-cerebrovascular system and on
tumor onset. After years of scientific doubts, today the scientific world agrees to define
cigarette smoking not a "vice" but a disease.
The aim is to evaluate the effect of no nicotine electronic cigarette use in patients with
cancer or myocardial infarction, smoking at least 10 cigarettes per day for at least 10
years, in addition to counselling activity performed by specialised dedicated medical
If patient is eligible for this trial, he will be enrolled in this trial and randomized.
Randomization will be performed using a web-based procedure. Study participants will be
randomized to electronic cigarette added to standard counselling or only standard
counselling. A calendar will be given to the patient to remember the dates of visits or
telephone counselling. After the first visit patient will be followed every ten days for the
first two month through outpatient clinic visits and telephone counselling. After the first
two months patient will return at institute for a last outpatient clinic visit at sixth
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of cigarettes smoked
two months after event (cancer or myocardial infarction)
Carlo Cipolla, MD
European Institute of Oncology
Italy: Ethics Committee