Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers (NCT03235505) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Finland450 participantsStarted 2018-08-01
Plain-language 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.
Who can participate
Age range
25 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 25 to under 75 years
* Has smoked over 10 years on a daily basis and being a current smoker with at least 10 cig/day for at least past 5 years
* Good general health
* Intent to quit smoking
* Exhaled carbon monoxide 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
* intent to quit smoking
* prepared to follow the trial protocol and able to provide written consent.
Exclusion Criteria:
* Pregnancy or gestation or intend to get pregnant during the study follow-up
* Use of smoking cessation pharmacotherapy or ECs during the past year
* Attempt of smoking cessation by using of e-cigarettes during the past year
* Any cancer (at least five healthy follow-up years after stopping the cancer therapy)
* Instable (ischemic) vascular or heart disease
* Recent myocardial infarction in the past three months
* High blood pressure (systolic BP\> 140mmHg or diastolic 90mmHg at rest)
* History of major psychiatric depression or other psychiatric conditions and daily use of any psychiatric medicine
* Current addiction of alcohol or misuse of substance
* Inability to express himself/herself
* Known allergy to any of the study medications
* Severe allergy or poorly controlled asthma or other pulmonary disease
* Epilepsy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Smoking cessation during the follow-up visit at week 26