Smoking Cessation Clinical Trial
Official title:
Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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