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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)

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:
NCT01188239
First received: August 19, 2010
Last updated: January 7, 2013
Last verified: January 2013

August 19, 2010
January 7, 2013
April 2010
April 2012   (final data collection date for primary outcome measure)
  • 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 ]
    50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12)
  • Sustained smoking abstinence at week-12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01188239 on ClinicalTrials.gov Archive Site
  • 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 ]
    80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12).
  • Sustained smoking abstinence at week-24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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.
  • Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline [ Time Frame: week-24 ] [ Designated as safety issue: No ]
    50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24).
  • Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline [ Time Frame: week-24 ] [ Designated as safety issue: No ]
    80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24).
  • Withdrawal suppression (by MNWS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Cravings reduction (by VAS) [ Time Frame: 24 wks ] [ Designated as safety issue: No ]
  • Reported adverse events rate from baseline [ Time Frame: 24 wks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Healthy Smokers
  • Smoking Cessation
Not Provided
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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01188239
CAT02/10
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