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Completed

NCT Number: NCT01195597

Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Smoking Reduction Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Catania, 95124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Cigarette 7.2 mg nicotine

Device

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 names: E-Cigarette with nicotine cartridges

Primary outcomes

  1. 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

    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).

Secondary outcomes

  1. 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

    Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Collaborators

  • Arbi Group Srl
  • Lega Italiana Anti Fumo

Registry information

Official study title

Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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