N/A N=40 Treatment

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

Nicotine Dependence · Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT01195597 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) — 13 number of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: E-Cigarette 7.2 mg nicotine (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Universita degli Studi di Catania
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)	13	—
SECONDARY Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)	5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01195597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.