A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)

Study Overview
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Brief Summary
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The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine 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) using initially for 6 weeks ORIGINAL 7.4 mg nicotine cartridges followed by a further 6 weeks of CATEGORIA 5.2 mg nicotine cartridges. The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

Detailed Description
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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 initially loaded with ORIGINAL 7.4 mg nicotine cartridges for 6 weeks followed by CATEGORIA 5.2 mg nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24 weeks.

Official Title
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Twelve Weeks Study Investigating the Efficacy and Safety of a Widely Marketed Electronic Nicotine Delivery Device (E-Cigarette): 6 Weeks on High Dose Nicotine and 6 Weeks on Low Dose Nicotine Cartridges in Smokers

Conditions
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Healthy Smokers, Smoking Cessation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy smokers unwilling to quit 18 and 60 years of age cigarette intake of ≥ 15 cig/day for at least 5 years CO level of ≥ 15 ppm FTND ≥ 5 Exclusion Criteria: alcohol and illicit drug use breastfeeding, or pregnancy current attempts to quit smoking previous experience with electronic cigarettes

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIGH 6wks LOW 6wks NICOTINE<br>Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with ORIGINAL 7.4 mg nicotine cartridges for 6 weeks followed by CATEGORIA 5.2 mg nicotine cartridges for a further 6 weeks (high and low nicotine group). | |

What is the study measuring?
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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 | 80% 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 weeks | 
| Cravings reduction (by VAS) |  | 24 wks | 
| Reported adverse events rate from baseline |  | 24 wks | 

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