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)

NCT01188239 | Completed DMC

• 1 other identifier: CAT02/10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Smokers; Smoking Cessation

Keywords

electronic cigarette; nicotine; smoking cessation; smoking reduction

Outcome Measures

Primary Outcomes (2)

• Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline

  50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12)

  week-12

• Sustained smoking abstinence at 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.

  week 12

Secondary Outcomes (7)

• Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline

  week-12

• Sustained smoking abstinence at week-24

  week 24

• Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline

  week-24

• Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline

  week-24

• Withdrawal suppression (by MNWS)

  24 weeks

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• healthy smokers unwilling to quit
• and 60 years of age
• cigarette intake of ≥ 15 cig/day for at least 5 years
• CO level of ≥ 15 ppm
• FTND ≥ 5

You may not qualify if:

• alcohol and illicit drug use
• breastfeeding, or pregnancy
• current attempts to quit smoking
• previous experience with electronic cigarettes

Sponsors & Collaborators

• Universita degli Studi di Catania: lead
• Lega Italiana Anti Fumo: collaborator
• Arbi Group Srl: collaborator

Study Sites (1)

Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Smoking Cessation; Vaping; Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Officials

• Riccardo Polosa, MD PhD

  Università di Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Centro per la Prevenzione e Cura del Tabagismo

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 25, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

IT (1)