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

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

Sponsors

Lead Sponsor: Universita degli Studi di Catania

Collaborator: Lega Italiana Anti Fumo
Arbi Group Srl

Source Universita degli Studi di Catania
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.</

Overall Status Completed
Start Date 2010-04-01
Completion Date 2012-04-01
Primary Completion Date 2012-04-01
Study Type Observational
Primary Outcome
Measure Time Frame
Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline week-12
Sustained smoking abstinence at week-12 week 12
Secondary Outcome
Measure Time Frame
Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline week-12
Sustained smoking abstinence at week-24 week 24
Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline week-24
Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline week-24
Withdrawal suppression (by MNWS) 24 weeks
Cravings reduction (by VAS) 24 wks
Reported adverse events rate from baseline 24 wks
Enrollment 100
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Riccardo Polosa, MD, PhD Principal Investigator Università di Catania
Location
Facility: Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Location Countries

Italy

Verification Date

2013-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universita degli Studi di Catania

Investigator Full Name: Riccardo Polosa

Investigator Title: Professor of Internal Medicine

Keywords
Has Expanded Access No
Arm Group

Label: NO NICOTINE

Description: Well characterized group of 100 regular smokers experimenting the E-Cigarette without nicotine cartridges (NO nicotine group).

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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