Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03235505
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT03235505
Study Brief:
Protocol Section:
NCT03235505