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

This study has been completed.
Sponsor:
Collaborators:
Lega Italiana Anti Fumo
Arbi Group Srl
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT01195597
First received: September 3, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Nicotine Dependence
Smoking Cessation
Device: E-Cigarette 7.2 mg nicotine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Universita degli Studi di Catania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24


Enrollment: 40
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: E-Cigarette with nicotine cartridges

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195597

Locations
Italy
Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Catania, Italy, 95124
Sponsors and Collaborators
Universita degli Studi di Catania
Lega Italiana Anti Fumo
Arbi Group Srl
Investigators
Principal Investigator: Riccardo Polosa, MD, PhD Università di Catania
  More Information

No publications provided by Universita degli Studi di Catania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Riccardo Polosa, Professor of Internal Medicine, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT01195597     History of Changes
Other Study ID Numbers: CAT00/10
Study First Received: September 3, 2010
Results First Received: May 22, 2012
Last Updated: January 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Universita degli Studi di Catania:
electronic cigarette
ENDD
nicotine
smoking cessation
smoking reduction

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014