Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)

January 3, 2013 updated by: Riccardo Polosa, Universita degli Studi di Catania

Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study

The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated.

In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, 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 product preferences were also reviewed.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • alcohol and illicit drug use
  • breastfeeding or pregnancy
  • major depression or other psychiatric conditions
  • previous experience with ENDD
  • recent myocardial infarction
  • angina pectoris
  • high blood pressure (BP>140mm Hg systolic and/or 90mmHg diastolic)
  • diabetes mellitus
  • severe allergies
  • poorly controlled asthma or other airways diseases

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-Cigarette 7.2 mg nicotine
Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Device: E-Cigarette 7.2 mg nicotine
Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer
Other Names:
  • E-Cigarette with nicotine cartridges

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
Time Frame: number of cigarettes/day as assessed at week 24
Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).
number of cigarettes/day as assessed at week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)
Time Frame: number of cigarettes/day as assessed at week 24
Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24
number of cigarettes/day as assessed at week 24

Collaborators and Investigators

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

Sponsor

Universita degli Studi di Catania

Collaborators

Lega Italiana Anti Fumo
Arbi Group Srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT00/10

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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