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High Cessation Rates in Smokers Using Personal Vaporizers (VAPECIG)

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ClinicalTrials.gov Identifier: NCT02124200
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Riccardo Polosa, 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.


Condition or disease Intervention/treatment Phase
Tobacco Addiction Device: EGO/CE4, 9mg nicotine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Study Start Date : January 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
EGO/CE4, 9mg nicotine Device: EGO/CE4, 9mg nicotine



Primary Outcome Measures :
  1. reducers [ Time Frame: week-24 from baseline ]
    sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers)


Secondary Outcome Measures :
  1. heavy reducers and quitters [ Time Frame: week-24 from baseline ]
    sustained 80% reduction in the number of cig/day (heavy reducers) and sustained smoking abstinence at week-24 (quitters)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124200


Locations
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Italy
1Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", Università di Catania,
Catania, Italy, 95100
Sponsors and Collaborators
Universita degli Studi di Catania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Riccardo Polosa, Full Professor of Internal Medicine, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT02124200     History of Changes
Other Study ID Numbers: Personal Vape Pilot (Vapecig)
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action