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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 loaded with "ORIGINAL" 7.2 mg nicotine cartridges and followed up for a total of 24 weeks. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01164072
Study type	Observational
Source	Universita degli Studi di Catania
Contact
Status	Completed
Phase	N/A
Start date	April 2010
Completion date	April 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms