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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT02870218
Eligibility Criteria:
Inclusion Criteria:
1. Subject is healthy as judged by the Investigator based on all available assessments from the Screening Period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
2. Subject smokes on average four days a week for the last 12 months.
3. Subject has no intention of quitting smoking within the next 90 days.
4. Owns a smart phone with text message and data capabilities.
5. Willingness to use and ability to operate e-cigarettes.
6. Willingness to smoke Research Cigarettes.
Exclusion Criteria:
1. Any medical or psychiatric condition (or associated symptoms or medications) determined by a medical professional to be severe enough to be disruptive to the study.
2. Severe or uncontrolled psychiatric disease with the exception of anxiety disorders, obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD);
3. Pregnant or nursing (by self-report) or positive pregnancy test;
4. Daily use of:
1. Experimental (investigational) drugs that are unknown to subject;
2. Smokeless tobacco (chewing tobacco, snuff), cigars, pipes and hookah;
3. e-cigarettes;
5. Use in the past 30 days of nicotine replacement therapy or other smoking cessation product
6. Positive drug screen for cocaine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02870218
Study Brief:
Protocol Section:
NCT02870218