High Cessation Rates in Smokers Using Personal Vaporizers

Phase 4

Completed

• Conditions: Tobacco Addiction
• Interventions: Device: EGO/CE4, 9mg nicotine

• Registration Number: NCT02124200
• Lead Sponsor: Universita degli Studi di Catania

Brief Summary

E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-09
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

Exclusion Criteria

history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (>140mmHg systolic and/or >90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGO/CE4, 9mg nicotine	EGO/CE4, 9mg nicotine	-

Primary Outcome Measures

Name	Time	Method
reducers	week-24 from baseline	sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers)

Secondary Outcome Measures

Name	Time	Method
heavy reducers and quitters	week-24 from baseline	sustained 80% reduction in the number of cig/day (heavy reducers) and sustained smoking abstinence at week-24 (quitters)

Trial Locations

Locations (1)

1Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", Università di Catania,; 🇮🇹 Catania, Italy