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High Cessation Rates in Smokers Using Personal Vaporizers (VAPECIG)

Primary Purpose

Tobacco Addiction

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
EGO/CE4, 9mg nicotine
Sponsored by
Universita degli Studi di Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Addiction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EGO/CE4, 9mg nicotine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2014
Last Updated
June 9, 2014
Sponsor
Universita degli Studi di Catania
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1. Study Identification

Unique Protocol Identification Number
NCT02124200
Brief Title
High Cessation Rates in Smokers Using Personal Vaporizers
Acronym
VAPECIG
Official Title
High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita degli Studi di Catania

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGO/CE4, 9mg nicotine
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
EGO/CE4, 9mg nicotine
Primary Outcome Measure Information:
Title
reducers
Description
sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers)
Time Frame
week-24 from baseline
Secondary Outcome Measure Information:
Title
heavy reducers and quitters
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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). - 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 -
Facility Information:
Facility Name
1Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", Università di Catania,
City
Catania
ZIP/Postal Code
95100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25380748
Citation
Polosa R, Caponnetto P, Maglia M, Morjaria JB, Russo C. Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit. BMC Public Health. 2014 Nov 8;14:1159. doi: 10.1186/1471-2458-14-1159.
Results Reference
derived

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High Cessation Rates in Smokers Using Personal Vaporizers

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