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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03557294
Eligibility Criteria:
Inclusion Criteria for the In-person Cohort
1. 21 years of age or older
2. Self-reported daily smoker
3. Breath CO \> 10ppm
4. Motivated to quit smoking completely within five weeks of the Screening Visit (\>5 on reported motivation)
5. Capable of and agree to complete study requirements
6. Literate in English, self-report
7. Must be available for the duration of study
8. Informed consent obtained
9. Willing and able to provide additional data between visits using ecological momentary assessment (EMA)
10. Must own study compatible smart-phone (iPhone or Android)
Exclusion Criteria for the In-person Cohort
1. Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months.
2. Any self-report, diagnosis or treatment of bipolar, schizophrenia or suicidal ideation within the last six months. (For suicidal ideation a score of ≥7 on the Suicidal Behavior Questionnaire, see Appendix 15)
3. Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate
4. Systolic blood pressure 160 or higher and/or diastolic blood pressure 100 or higher (see site applicable SOP for Evaluating and Reporting Blood Pressure and Appendices 5 and 6 for participant handouts)
5. History of renal disease
6. Allergy to any of the ingredients in varenicline
7. Participation in another smoking cessation program or any type of clinical trial in the past 3 months
8. Use of any smoking cessation medication in the past three months
9. Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study
10. Positive drug screen indicating possible substance abuse (eg opiates, amphetamines, benzodiazepines, cocaine or other substances), unless participant can show that the medication has been prescribed by licensed clinical provider.
11. Consume greater than 21 alcohol drinks per week.
12. No two members of the same household may participate in this study
13. No study staff or their immediate family may participate in the study
14. Females who are pregnant, breast feeding, or not currently using a medically approved form of birth control and unwilling to do so.
Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms.
Inclusion Criteria for the Remote Cohort
1. 21 years of age or older
2. Self-reported daily smoker
3. Positive cotinine from urine sample
4. Motivated to quit smoking completely within five weeks of the Screening Visit (\>5 on reported motivation)
5. Capable of and agree to complete study requirements
6. Literate in English, self-report
7. Must be available for the duration of study
8. Informed consent obtained
10\. Must own study compatible smart-phone (iPhone or Android) 11. Must be a current resident of the United States
Exclusion Criteria for the Remote Cohort
1. Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months.
2. Any self-report, diagnosis or treatment of bipolar, schizophrenia or suicidal ideation within the last six months. (For suicidal ideation a score of ≥7 on the Suicidal Behavior Questionnaire, see Appendix 15)
3. Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate
4. History of renal disease
5. Allergy to any of the ingredients in varenicline
6. Participation in another smoking cessation program or any type of clinical trial in the past 3 months
7. Use of any smoking cessation medication in the past three months
8. Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study
9. Consume greater than 21 alcohol drinks per week.
10. No two members of the same household may participate in this study
11. No study staff or their immediate family may participate in the study
12. Females who are pregnant, breast feeding, or not currently using a medically approved form of birth control and unwilling to do so.
Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03557294
Study Brief:
Protocol Section:
NCT03557294