Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges

Tracking Information
First Submitted Date	September 2, 2010
First Posted Date	September 3, 2010
Last Update Posted Date	January 8, 2013
Study Start Date	April 2010
Actual Primary Completion Date	April 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 2, 2010)	Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ]50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12); Sustained smoking abstinence at week-12 [ Time Frame: 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.
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01194583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 2, 2010)	Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ]80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12).; Sustained smoking abstinence at week-24 [ Time Frame: 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.; Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline [ Time Frame: week-24 ]50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24); Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline [ Time Frame: week-24 ]50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24).; Withdrawal suppression (by MNWS) [ Time Frame: 24 weeks ]; Cravings reduction (by VAS) [ Time Frame: 24 wks ]; Reported adverse events rate from baseline [ Time Frame: 24 wks ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges
Official Title	Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges in Smokers
Brief 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 - "NO 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 independently from nicotine delivery.
Detailed 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 without nicotine ("NO nicotine" cartridges) and followed up for a total of 24 weeks.</
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.
Condition	Healthy Smokers; Smoking Cessation
Intervention	Not Provided
Study Groups/Cohorts	NO NICOTINE; Well characterized group of 100 regular smokers experimenting the E-Cigarette without nicotine cartridges (NO nicotine group).
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 2, 2010)	100
Original Estimated Enrollment	Same as current
Actual Study Completion Date	April 2012
Actual Primary Completion Date	April 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Italy
Removed Location Countries
Administrative Information
NCT Number	NCT01194583
Other Study ID Numbers	CAT03/10
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Riccardo Polosa, Universita degli Studi di Catania
Study Sponsor	Universita degli Studi di Catania
Collaborators	Lega Italiana Anti Fumo; Arbi Group Srl
Investigators	Principal Investigator: Riccardo Polosa, MD, PhD Università di Catania
PRS Account	Universita degli Studi di Catania
Verification Date	January 2013