Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)

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 (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product. This pilot study will evaluate smoking reduction/abstinence effects, product preferences, 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.

Detailed Description
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Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated. In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, 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 product preferences were also reviewed.

Official Title
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Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study

Conditions
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Nicotine Dependence, Smoking Cessation

Intervention / Treatment
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* Device: E-Cigarette 7.2 mg nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy smokers unwilling to quit age 18-60 years smoking ≥ 15 cig/day for at least 5 years exhaled CO level of ≥ 15 ppm FTND ≥ 5 Exclusion Criteria: alcohol and illicit drug use breastfeeding or pregnancy major depression or other psychiatric conditions previous experience with ENDD recent myocardial infarction angina pectoris high blood pressure (BP>140mm Hg systolic and/or 90mmHg diastolic) diabetes mellitus severe allergies poorly controlled asthma or other airways diseases

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Cigarette 7.2 mg nicotine<br>Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. | Device: E-Cigarette 7.2 mg nicotine<br>* Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer<br>* Other names: E-Cigarette with nicotine cartridges;|

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 Cig/Day at Week-24 From Baseline (Reducers) | Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers). | number of cigarettes/day as assessed at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers) | Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24 | number of cigarettes/day as assessed at week 24 | 

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