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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

September 3, 2010
January 3, 2013
February 2010
June 2010   (final data collection date for primary outcome measure)
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).
Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ] [ Designated as safety issue: No ]
sustained self-reported 50% reduction in the number of cig/day compared to baseline for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status and to document a reduction compared to baseline)
Complete list of historical versions of study NCT01195597 on ClinicalTrials.gov Archive Site
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
  • Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ] [ Designated as safety issue: No ]
    sustained self-reported 80% reduction in the number of cig/day compared to baseline for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status and to document a reduction compared to baseline)
  • Sustained smoking abstinence at week-12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    complete self-reported abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status with an eCO concentration of ≤10 ppm )
Not Provided
Not Provided
 
Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nicotine Dependence
  • Smoking Cessation
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
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.
Intervention: Device: E-Cigarette 7.2 mg nicotine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01195597
CAT00/10
Yes
Riccardo Polosa, Universita degli Studi di Catania
Universita degli Studi di Catania
  • Lega Italiana Anti Fumo
  • Arbi Group Srl
Principal Investigator: Riccardo Polosa, MD, PhD Università di Catania
Universita degli Studi di Catania
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP