Clinical Trials Directory

Trials / Completed

CompletedNCT02124200

High Cessation Rates in Smokers Using Personal Vaporizers

High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Universita degli Studi di Catania · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEGO/CE4, 9mg nicotine

Timeline

Start date
2013-01-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2014-04-28
Last updated
2014-06-10

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02124200. Inclusion in this directory is not an endorsement.