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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT02941718
Eligibility Criteria:
Inclusion Criteria:
1. adults (\>18 -65) who smoke at least 8 cigarettes/day;
2. Report wanting to quit smoking in the next month
3. No current diagnosis of psychosis or bipolar disorder.
4. able to communicate in English and provide written informed consent for study procedures
5. able to use varenicline safely.
6. No current diagnosis of any sleep disorders (except of insomnia)
7. Have access to a smart phone or tablet own the home
Exclusion Criteria:
1. Current enrollment or plans to enroll in another smoking cessation program and/or use a nicotine substitute (e.g., e-cigarettes) in the next 6 months,
2. Current use of illicit drugs (e.g., cocaine, opioids, or methamphetamines),
3. Current alcohol consumption that exceeds 14 standard alcoholic drinks/week for men, and more than 7 for women.
4. Current use or recent discontinuation (within last 14 days) of anti-psychotic and/or bipolar disorder medications,
5. Women who are pregnant, planning a pregnancy within the next 6 months, or lactating,
6. Uncontrolled hypertension (SBP \>160 or DBP \>100)
7. Current sleep disorder or use of sleep medication
8. History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval),
9. Any current suicidal ideation, or self-reported suicide attempt
10. Current or past diagnosis of psychotic or bipolar disorder
11. Currently working night/rotating shift.
12. Allergy to Varenicline
13. Unstable or untreated moderate or severe depression as assessed by the center for epidemiology studies depression scale 16 for higher.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02941718
Study Brief:
Protocol Section:
NCT02941718