An observational study in Healthy Smokers and Smoking Cessation, sponsored by Universita degli Studi di Catania. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-08.
Sponsored by Universita degli Studi di Catania · Observational
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.
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.
Universita degli Studi di Catania is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.
Inclusion Criteria: healthy smokers unwilling to quit, between 18 and 60 years of age. They should report a cigarette intake of ≥ 15 cig/day for at least 5 years. At screening they must provide a CO level of ≥ 15 ppm and an FTND ≥ 5.
Exclusion Criteria: alcohol and illicit drug use, breastfeeding, or pregnancy. Individuals who report current attempts to quit smoking and previous experience with electronic cigarettes will be also excluded.
Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with 7.2 mg nicotine cartridges (high nicotine group).
Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline
50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12)
Time frame: week-12
Sustained smoking abstinence at week-12
Sustained smoking abstinence at week-12, defined as complete abstinence from tobacco smoking (not even a puff) for the 14 days period prior to week-12 study visit; exhaled CO levels will be measured to objectively verify smoking status.
Time frame: week 12
Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline
80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12)
Time frame: week-12
Sustained smoking abstinence at week-24
Sustained smoking abstinence at week-24, defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-24 study visit; exhaled CO levels will be measured to objectively verify smoking status.
Time frame: week 24
Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline
50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24)
Time frame: week-24
Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline
50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24)
Time frame: week-24
Withdrawal suppression (by MNWS)
Time frame: 24 wks
Cravings reduction (by VAS)
Time frame: 24 wks
Reported adverse events rate from baseline
Time frame: 24 wks
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Universita degli Studi di Catania