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

• Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ] [ Designated as safety issue: No ]
  sustained self-reported 80% reduction in the number of cig/day compared to baseline for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status and to document a reduction compared to baseline)
• Sustained smoking abstinence at week-12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  complete self-reported abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status with an eCO concentration of ≤10 ppm )

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.

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.

• Nicotine Dependence
• Smoking Cessation

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

• LegaItalianaAntiFumo(LIAF Onlus)
• Arbi Group Srl