Clinical trial NCT01188239: A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)
Official title: Twelve Weeks Study Investigating the Efficacy and Safety of a Widely Marketed Electronic Nicotine Delivery Device (E-Cigarette): 6 Weeks on High Dose Nicotine and 6 Weeks on Low Dose Nicotine Cartridges in Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Smokers
Smoking Cessation
Keywords: electronic cigarette
nicotine
smoking cessation
smoking reduction
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
Collaborators: name: Lega Italiana Anti Fumo
name: Arbi Group Srl
First posted: 2010-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.

Brief summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine 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) using initially for 6 weeks "ORIGINAL" 7.4 mg nicotine cartridges followed by a further 6 weeks of "CATEGORIA" 5.2 mg nicotine cartridges. The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

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 initially loaded with "ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24 weeks.

Eligibility criteria: Inclusion Criteria:

* healthy smokers unwilling to quit
* 18 and 60 years of age
* cigarette intake of ≥ 15 cig/day for at least 5 years
* CO level of ≥ 15 ppm
* FTND ≥ 5

Exclusion Criteria:

* alcohol and illicit drug use
* breastfeeding, or pregnancy
* current attempts to quit smoking
* previous experience with electronic cigarettes

Primary outcomes:
measure: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline
timeFrame: week-12
measure: Sustained smoking abstinence at week-12
timeFrame: week 12
Secondary outcomes:
measure: Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline
timeFrame: week-12
measure: Sustained smoking abstinence at week-24
timeFrame: week 24
measure: Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline
timeFrame: week-24
measure: Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline
timeFrame: week-24
measure: Withdrawal suppression (by MNWS)
timeFrame: 24 weeks
measure: Cravings reduction (by VAS)
timeFrame: 24 wks
measure: Reported adverse events rate from baseline
timeFrame: 24 wks
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Study officials:
affiliation: Università di Catania
name: Riccardo Polosa, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: