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:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT02906995
Eligibility Criteria:
Inclusion Criteria:
1. Participants have to be 18-45 years old
2. Participants must provide written informed consent prior to any study related procedures being performed.
3. Participants must have a willingness and ability to comply with the protocol requirements.
4. Participants must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)
5. Female participants of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
6. Participants must consume more than 10 cigarettes daily and Fagerström Test for Nicotine Dependence score of 4 or greater.
7. Participants must have no intention of quitting smoking in the next 60 days.
Exclusion Criteria:
1. Volunteers that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc within 30 days of study entry.
2. Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
3. Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.
4. Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.
5. Volunteers with diagnosed stomach ulcers.
6. Volunteers who are taking insulin for diabetes.
7. Volunteers with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic.
8. Volunteers who are unable to fulfill the visit schedule
9. Volunteers who have severe allergic history
10. Volunteers who have known intolerance to medication
11. Volunteers who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
12. Volunteers who had surgical operations on gastrointestinal tract with the exception of appendectomy
13. Volunteers who donated 450 mL and more of his/her blood or blood plasma within the last 2 months prior to the study entry
14. Volunteers who meet criteria for dependence on a substance other than nicotine.
15. Participants having a body mass index below 18 or over 35.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02906995
Study Brief:
Protocol Section:
NCT02906995