A Phase 4 interventional study of EGO/CE4, 9mg nicotine in Tobacco Addiction, sponsored by Universita degli Studi di Catania. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2014-06-10.
Sponsored by Universita degli Studi di Catania · Phase 4, Interventional, and Treatment
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.
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →Universita degli Studi di Catania is the lead sponsor of 13 studies on the registry; none are open to participants now.
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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).
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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
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Device: EGO/CE4, 9mg nicotine
reducers
sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers)
Time frame: week-24 from baseline
heavy reducers and quitters
sustained 80% reduction in the number of cig/day (heavy reducers) and sustained smoking abstinence at week-24 (quitters)
Time frame: week-24 from baseline
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Universita degli Studi di Catania