Status:
COMPLETED
Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Lead Sponsor:
University of Oulu
Collaborating Sponsors:
Lapland Central Hospital Rovaniemi Finland
Conditions:
Smoking Cessation
Electronic Cigarette
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief 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 unk...
Detailed Description
This is a study with three arms. Each arm has 12 weeks intervention and observation up to 12 months: A.Nicotine containing e-cigarettes + placebo-pills + Motivational Interview (MI) Innokin Endura T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03235505
Start Date
August 1 2018
End Date
March 31 2021
Last Update
May 16 2024
Active Locations (1)
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1
Lapland Central Hospital
Rovaniemi, Finland, 96440