Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette)

Study Overview
=================
Brief Summary
-----------------
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy (Categoria electronic cigarette - ORIGINAL 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

Detailed Description
-----------------
The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary for its operation. For these reasons, it is possible that this product may be safer than cigarettes. Marketing claims also include that they can be useful smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to that of tobacco cigarettes and reproduces the gesture component associated with tobacco smoking, very little is known about the effect of E-Cigarette on the smoking habits of regular tobacco smokers. Therefore, we designed a prospective observational study consisting of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well characterized regular smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events. Specifically, 100 smokers will be given Categoria electronic cigarette loaded with ORIGINAL 7.2 mg nicotine cartridges and followed up for a total of 24 weeks.

Official Title
-----------------
Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers

Conditions
-----------------
Healthy Smokers, Smoking Cessation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy smokers unwilling to quit, between 18 and 60 years of age. They should report a cigarette intake of ≥ 15 cig/day for at least 5 years. At screening they must provide a CO level of ≥ 15 ppm and an FTND ≥ 5. Exclusion Criteria: alcohol and illicit drug use, breastfeeding, or pregnancy. Individuals who report current attempts to quit smoking and previous experience with electronic cigarettes will be also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIGH NICOTINE<br>Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with 7.2 mg nicotine cartridges (high nicotine group). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline | 50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12) | week-12 | 
| Sustained smoking abstinence at week-12 | Sustained smoking abstinence at week-12, defined as complete abstinence from tobacco smoking (not even a puff) for the 14 days period prior to week-12 study visit; exhaled CO levels will be measured to objectively verify smoking status. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline | 80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12) | week-12 | 
| Sustained smoking abstinence at week-24 | Sustained smoking abstinence at week-24, defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-24 study visit; exhaled CO levels will be measured to objectively verify smoking status. | week 24 | 
| Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline | 50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24) | week-24 | 
| Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline | 50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24) | week-24 | 
| Withdrawal suppression (by MNWS) |  | 24 wks | 
| Cravings reduction (by VAS) |  | 24 wks | 
| Reported adverse events rate from baseline |  | 24 wks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electronic cigarette, nicotine, smoking cessation, smoking reduction