The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study

Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.

The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.

The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.

Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.

Inclusion Criteria:

• resident into the Abruzzo and Lazio Region
• aged between 30 and 75 years;
• smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
• smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
• smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).

Exclusion Criteria:

• illicit drug use,
• breastfeeding or pregnancy,
• major depression or other psychiatric conditions,
• severe allergies,
• active antihypertensive medication,
• angina pectoris,
• past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.