Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Bladder | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Cancer of the Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- E-cigarettes only
- description
- Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes
- label
- Traditional cigarettes only
- description
- Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers.
- label
- Mixed group
- description
- Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up
Primary outcomes (2)
- measure
- Traditional smoking cessation rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDManzoli L, La Vecchia C, Flacco ME, Capasso L, Simonetti V, Boccia S, Di Baldassarre A, Villari P, Mezzetti A, Cicolini G. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. BMC Public Health. 2013 Sep 24;13:883. doi: 10.1186/1471-2458-13-883. PMID 24063569
- RESULTManzoli L, Flacco ME, Fiore M, La Vecchia C, Marzuillo C, Gualano MR, Liguori G, Cicolini G, Capasso L, D'Amario C, Boccia S, Siliquini R, Ricciardi W, Villari P. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. PLoS One. 2015 Jun 10;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015. PMID 26061661
- RESULTManzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M. A cohort study of electronic cigarette use: Effectiveness and safety at 24 months. Tobacco Control 2016 Jun 7 (epub ahead of print). (doi: 10.1136/tobaccocontrol-2015-052822) Direct link: http://tobaccocontrol.bmj.com/content/early/2016/06/06/tobaccocontrol-2015-052822.full
- DERIVEDManzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M; ISLESE Working Group. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob Control. 2017 May;26(3):284-292. doi: 10.1136/tobaccocontrol-2015-052822. Epub 2016 Jun 6. PMID 27272748