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

This study has been completed.

Sponsor:

Collaborators:

Lega Italiana Anti Fumo

Arbi Group Srl

Information provided by (Responsible Party):

Riccardo Polosa, Universita degli Studi di Catania

ClinicalTrials.gov Identifier:

NCT01194583

First received: September 2, 2010

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2010

Last Updated Date

January 7, 2013

Start Date ^ICMJE

April 2010

Primary Completion Date

April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01194583 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Healthy Smokers
Smoking Cessation

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

April 2012

Primary Completion Date

April 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Italy

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01194583

Other Study ID Numbers ^ICMJE

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 ^ICMJE

Universita degli Studi di Catania

Collaborators ^ICMJE

Lega Italiana Anti Fumo
Arbi Group Srl

Investigators ^ICMJE

Principal Investigator:

Riccardo Polosa, MD, PhD

Università di Catania

PRS Account

Universita degli Studi di Catania

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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