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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT01898195
Eligibility Criteria:
Inclusion Criteria:
1. Current patient at one of two SLR CCC clinics with a designated physician (had intake visit and enrolled into clinic)
2. Age 18 years or older;
3. Current or regular smoker (\>5 cigarettes per day);
4. Carbon Monoxide (CO) monitor reading of \>8 ppm;
5. Willingness to set a quit date;
6. Able to conduct activities in English;
7. Ability to provide informed consent;
8. Willingness to carry/use a cell phone; AND
9. Eligible to take varenicline as determined by the patient's primary care provider
Exclusion Criteria:
1. Unstable cardiovascular disease (e.g. uncontrolled blood pressure, unstable angina, or myocardial infarction in the past 4 weeks);
2. Current homicidal or suicidal ideation, history of suicidal ideation, or history of psychosis;
3. Has a serious or untreated psychiatric illness (major depression, bipolar or schizophrenia);
4. Severe renal impairment (defined as having a creatinine clearance \< 30mL/min);
5. Currently using smokeless tobacco;
6. Currently using FDA-approved smoking cessation medication or other smoking cessation treatment and or participating in another smoking cessation program;
7. Active drug use identified by a score of 6 or above on DAST-10 Drug Abuse Screening Test;
8. Alcohol dependence or risk drinking identified by a score of 5 or above for men and 4 or above for women on AUDIT-C Alcohol Use Disorders Identification Test
9. Pregnant or nursing; AND/OR
10. Has a cognitive impairment that would preclude giving consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01898195
Study Brief:
Protocol Section:
NCT01898195