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

University of Catania · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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nicotinesmoking-cessation
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.
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