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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT02551692
Eligibility Criteria:
Inclusion criteria:
1. generally healthy \[(i.e. ambulatory, not currently sick)\]
2. between the ages of 18 and 60
3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for \> 1 year
4. an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \>1000 ng/mL (NicAlert = 6).
5. interest in quitting smoking within the timeframe of the experiment.
6. ability to identify 4 personal smoking and 4 personal non-smoking places.
Exclusion criteria:
1. immediate or no desire to quit smoking;
2. inability to attend all required experimental sessions;
3. use of psychoactive medications;
4. use of smokeless tobacco including e-cigarettes in the past 30 days;
5. current alcohol or drug abuse;
6. use of illegal drugs as measured by urine drug screen (excluding marijuana);
7. use of experimental (investigational) drugs;
8. current use of nicotine replacement therapy or other smoking cessation treatment;
9. Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
10. Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg);
11. Coronary heart disease;
12. Lifetime history of heart attack;
13. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure, arrhythmia); Abnormal EKG results suggestive of ischemia or undiagnosed cardiovascular disease please consider adding if it seems reasonable. For example, ST-segment depression or elevation, T-wave abnormalities, and lack of R wave are obtained with a 12-lead EKG).
14. Active skin disorder (e.g., psoriasis) within the last year, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
15. Medical condition that may contraindicate participation in the opinion of the investigator and study physician.(for example, EKG results)
16. Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
17. Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
18. Current depression - The Prime-MD will be used to screen for current (within 2 weeks) depression. Potential subjects who score \>9 (or who score \>0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
19. Bulimia or anorexia;
20. Significant adverse reaction to Chantix/Varenicline in the past;
21. Currently pregnant, breast feeding or likely to become pregnant;
22. History of seizure disorder.
23. A quit attempt within the last 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02551692
Study Brief:
Protocol Section:
NCT02551692