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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)

NCT01188239 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-01-08

No results posted yet for this study

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

Sponsors & Collaborators

  • Lega Italiana Anti Fumo

    collaborator OTHER

  • Arbi Group Srl

    collaborator INDUSTRY

  • Universita degli Studi di Catania

    lead OTHER

Principal Investigators

  • Riccardo Polosa, MD PhD · Università di Catania

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188239 on ClinicalTrials.gov