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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oulu
• Collaborator: Lapland Central Hospital Rovaniemi Finland
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Aged between 30 to under 70 years

• Has smoked over10 pack years and is a current smoker at least 10 cig/day for at least past 5 years

• Good general health

• Intent to quit smoking

• Exhaled carbon monoxide (exhaled- CO) level at least 15ppm at the baseline visit

• Strong nicotine dependence defined by Fagerström Test for Nicotine Dependence (FTND) ≥ 5 and by Heaviness of Smoking Index (HSI) ≥3

• Commits to follow the trial and can provide concent

Exclusion Criteria:

• Non-daily smoker

• Pregnancy or gestation or intend to get pregnant during the study follow-up

• Current use of smoking cessation pharmacotherapy

• Attempt of smoking cessation by using of e-cigarettes during the past year

• Any cancer

• Instable (ischemic) vascular or heart disease

• Recent myocardial infarction (3 months )

• Angina pectoris

• High blood pressure (systolic BP> 140mmHg and /or diastolic 90mmHg at rest)

• Daily use of any psychiatric medicine

• History of major psychiatric depression or other psychiatric conditions

• Current addiction of alcohol or misuse of substance

• Inability to express himself/herself

• Allergy to any of the study medications

• Any severe allergy

• Poorly controlled asthma or other chronic pulmonary disease

• Current use of any smoking cessation therapy