Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Abstract Rationale. Electronic cigarette use is increasing at an exponential rate in Finland
and internationally. The health consequences of vaporised aerosols in electronic cigarettes
are largely unknown especially in a long run. Still, very few studies are available on
quitting attempts with e-cigarettes as a smoking cessation tool compared to evidence based
cessation pharmacotherapy in adult smokers who want to quit.
Research Objective: To investigate effectiveness and safety of e-cigarettes for smoking
cessation in middle-aged smokers, and to compare the effectiveness of them to varenicline.
Our study provides new information of success in smoking cessation among heavy adult smokers
for clinicians.
Design: A double-blind, randomised, placebo-controlled clinical trial with the intervention
phase of 12 weeks and the observational phase up to 52 weeks. This is an investigator
initiated study.
Setting: Volunteer middle-aged daily smokers, who were recruited through newspaper
announcements. The majority of the cohort subjects (n=513)were recruited for our previous
follow-ip study during years 2003- 2009, and many of them continued daily smoking during the
whole follow-up period.
Participants: In all, 450 adult heavy smokers, who want to quit smoking and are willing to
participate up to 52 weeks´ follow-up.
Intervention and procedures: Standardized self-reported questionnaires with detailed smoking
history with assessment of motivation to quit smoking, parameters of nicotine dependence,
symptoms will be included. Smoking status will be repeatedly reassessed during the study
visits, and self-reported smoking abstinence is verified with exhaled-carbon monoxide (CO)
assessment. All adverse side effects either of drugs or of e-cigarettes, and symptoms related
to the drugs or to withdrawal from smoking will be carefully reported.