A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)

January 7, 2013 updated by: Riccardo Polosa, Universita degli Studi di Catania

Twelve Weeks Study Investigating the Efficacy and Safety of a Widely Marketed Electronic Nicotine Delivery Device (E-Cigarette): 6 Weeks on High Dose Nicotine and 6 Weeks on Low Dose Nicotine Cartridges in Smokers

The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette) using initially for 6 weeks "ORIGINAL" 7.4 mg nicotine cartridges followed by a further 6 weeks of "CATEGORIA" 5.2 mg nicotine cartridges. The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary for its operation. For these reasons, it is possible that this product may be safer than cigarettes. Marketing claims also include that they can be useful smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to that of tobacco cigarettes and reproduces the gesture component associated with tobacco smoking, very little is known about the effect of E-Cigarette on the smoking habits of regular tobacco smokers. Therefore, we designed a prospective observational study consisting of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well characterized regular smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events. Specifically, 100 smokers will be given "Categoria" electronic cigarette initially loaded with "ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.

Description

Inclusion Criteria:

  • healthy smokers unwilling to quit
  • 18 and 60 years of age
  • cigarette intake of ≥ 15 cig/day for at least 5 years
  • CO level of ≥ 15 ppm
  • FTND ≥ 5

Exclusion Criteria:

  • alcohol and illicit drug use
  • breastfeeding, or pregnancy
  • current attempts to quit smoking
  • previous experience with electronic cigarettes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
HIGH 6wks LOW 6wks NICOTINE
Well characterized group of 100 regular smokers experimenting the E-Cigarette loaded with ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg nicotine cartridges for a further 6 weeks (high and low nicotine group).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline
Time Frame: week-12
50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12)
week-12
Sustained smoking abstinence at week-12
Time Frame: week 12
Sustained smoking abstinence at week-12, defined as complete abstinence from tobacco smoking (not even a puff) for the 14 days period prior to week-12 study visit; exhaled CO levels will be measured to objectively verify smoking status.
week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline
Time Frame: week-12
80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12).
week-12
Sustained smoking abstinence at week-24
Time Frame: week 24
Sustained smoking abstinence at week-24, defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-24 study visit; exhaled CO levels will be measured to objectively verify smoking status.
week 24
Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline
Time Frame: week-24
50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24).
week-24
Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline
Time Frame: week-24
80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24).
week-24
Withdrawal suppression (by MNWS)
Time Frame: 24 weeks
24 weeks
Cravings reduction (by VAS)
Time Frame: 24 wks
24 wks
Reported adverse events rate from baseline
Time Frame: 24 wks
24 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universita degli Studi di Catania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lega Italiana Anti Fumo
Arbi Group Srl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Riccardo Polosa, MD PhD, Università di Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAT02/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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