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Tobacco AddictionPhase 4VAPECIGNCT02124200

High Cessation Rates in Smokers Using Personal Vaporizers

A Phase 4 study testing EGO/CE4, 9mg nicotine in people with Tobacco Addiction, run by University of Catania at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Tobacco Addiction
What is being tested?
EGO/CE4, 9mg nicotine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Jan 2013to Nov 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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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Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Catania, Italy, 95100

Other trials in Italy

About this study

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

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.

Being tested
EGO/CE4, 9mg nicotine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGO/CE4, 9mg nicotineDevice

Study groups in NCT02124200
Study groupRoleWhat they receive
EGO/CE4, 9mg nicotineOtherNot described
Receives: Device: EGO/CE4, 9mg nicotine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. reducers

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

    Measured: week-24 from baseline

Secondary outcomes (1)

  1. heavy reducers and quitters

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

    Measured: week-24 from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02124200
Sponsor's protocol ID
Personal Vape Pilot (Vapecig)
Acronym
VAPECIG
Status last verified
Jun 2014
First submitted
24 Apr 2014
Last updated
10 Jun 2014
Results posted
No

Publications

  • 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.

    PubMed 25380748

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EGO/CE4, 9mg nicotine in people with Tobacco Addiction, run by University of Catania at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reducers (time frame: week-24 from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02124200, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014; AzTrials last refreshed its copy on 5 Nov 2026.

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