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Trial record 3 of 13 for:    polosa

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)

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ClinicalTrials.gov Identifier: NCT01188239
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : January 8, 2013
Sponsor:
Collaborators:
Lega Italiana Anti Fumo
Arbi Group Srl
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania

Tracking Information
First Submitted Date August 19, 2010
First Posted Date August 25, 2010
Last Update Posted Date January 8, 2013
Study Start Date April 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2010)
  • 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)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01188239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 24, 2010)
  • 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).
  • 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.
  • 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).
  • 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).
  • Withdrawal suppression (by MNWS) [ Time Frame: 24 weeks ]
  • Cravings reduction (by VAS) [ Time Frame: 24 wks ]
  • Reported adverse events rate from baseline [ Time Frame: 24 wks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
Official Title 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
Brief Summary 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Regular smokers from Catania in Italy recruited following the placement of an advertisement in a local newspaper.
Condition
  • Healthy Smokers
  • Smoking Cessation
Intervention Not Provided
Study Groups/Cohorts 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 24, 2010)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01188239
Other Study ID Numbers CAT02/10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Riccardo Polosa, Universita degli Studi di Catania
Study Sponsor Universita degli Studi di Catania
Collaborators
  • Lega Italiana Anti Fumo
  • Arbi Group Srl
Investigators
Principal Investigator: Riccardo Polosa, MD PhD Università di Catania
PRS Account Universita degli Studi di Catania
Verification Date January 2013