High Cessation Rates in Smokers Using Personal Vaporizers

Study Overview
=================
Brief Summary
-----------------
E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated. In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.

Official Title
-----------------
High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study

Conditions
-----------------
Tobacco Addiction

Intervention / Treatment
-----------------
* Device: EGO/CE4, 9mg nicotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy). - Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (>140mmHg systolic and/or >90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EGO/CE4, 9mg nicotine<br> | Device: EGO/CE4, 9mg nicotine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducers | sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers) | week-24 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heavy reducers and quitters | sustained 80% reduction in the number of cig/day (heavy reducers) and sustained smoking abstinence at week-24 (quitters) | week-24 from baseline |