Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers

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. Some of the cohort subjects were re-recruited from our previous follow-up study as many of them continued daily smoking during the whole follow-up period.

Participants: Targeted sample size of 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.

Conditions

• Smoking Cessation
• Electronic Cigarette

Interventions

DRUG

Nicotine

Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)

DRUG

Varenicline Tartrate

Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI

BEHAVIORAL

Motivational Interview

Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI

Sponsors & Collaborators

• Lapland Central Hospital Rovaniemi Finland

  collaborator UNKNOWN

• University of Oulu

  lead OTHER

Principal Investigators

• Tuula Toljamo, PhD · Laplnd Central Hospital Rovaniemi Finland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2021-03-31

Completion

2021-03-31

Countries

• Finland

Study Locations