Completed

NCT Number: NCT01164072

Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette)

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 - "ORIGINAL" 7.2 mg 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.

Completed

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Key information

Conditions

Healthy Smokers Behavior Health Behavior Smoking Smoking Cessation Smoking Reduction Vaping

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)

Catania, 95124, Italy

About this study

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 with "ORIGINAL" 7.2 mg nicotine cartridges and followed up for a total of 24 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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 wks
Cravings reduction (by VAS)

Time frame: 24 wks
Reported adverse events rate from baseline

Time frame: 24 wks

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Collaborators

Arbi Group Srl
Lega Italiana Anti Fumo

Registry information

Official study title

Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jul 16, 2010
Registry last updated: Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed