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)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Healthy Smokers

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95124
    • Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIGH 6wks LOW 6wks NICOTINE; Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg nicotine cartridges for a further 6 weeks (high and low nicotine group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline	80% 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
Withdrawal suppression (by MNWS)		24 weeks
Cravings reduction (by VAS)		24 wks
Reported adverse events rate from baseline		24 wks

Collaborators and Investigators

• Sponsor: Universita degli Studi di Catania
• Collaborators: Lega Italiana Anti Fumo; Arbi Group Srl
• Investigators: Principal Investigator: Riccardo Polosa, MD PhD, Università di Catania

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: smoking cessation; electronic cigarette; nicotine; smoking reduction
• Other Study ID Numbers: CAT02/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No