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

Smoking Cessation Clinical Trial

Official title:

Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194583
• Other study ID #: CAT03/10
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: January 7, 2013
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2013
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

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 - "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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Smokers
• Smoking Cessation

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)	Catania

Sponsors (3)

Lead Sponsor	Collaborator
Universita degli Studi di Catania	Arbi Group Srl, Lega Italiana Anti Fumo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	week-12	No
Primary	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.	week 12	No
Secondary	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).	week-12	No
Secondary	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.	week 24	No
Secondary	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)	week-24	No
Secondary	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).	week-24	No
Secondary	Withdrawal suppression (by MNWS)		24 weeks	No
Secondary	Cravings reduction (by VAS)		24 wks	No
Secondary	Reported adverse events rate from baseline		24 wks	Yes