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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195597
• Other study ID #: CAT00/10
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: January 3, 2013
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: January 2013
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation

Intervention

Device:
• E-Cigarette 7.2 mg nicotine
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

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)	Catania

Sponsors (3)

Lead Sponsor	Collaborator
Universita degli Studi di Catania	Arbi Group Srl, Lega Italiana Anti Fumo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)	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).	number of cigarettes/day as assessed at week 24	No
Secondary	Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)	Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24	number of cigarettes/day as assessed at week 24	No