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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02750904
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 or older
2. Daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm
3. Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)
4. Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria
5. Willing to be randomly assigned to either treatment group
6. Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer
7. Willing and able to read in English
8. Is under care of a clinician for the treatment of bipolar disorder
9. Willing to authorize communication with the clinician regarding study participation and clinical deterioration
10. Willing to use the nicotine patch to help quit smoking
Exclusion Criteria:
1. Participating in other smoking cessation interventions
2. Currently using any pharmacotherapies for smoking cessation
3. Previous use of the Smokefree.gov website
4. Meets DSM-V criteria for current mania
5. Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score \> 14)
6. Current psychotic symptoms
7. Psychiatric hospitalization within one month prior to enrollment
8. Current suicidal or homicidal ideation
9. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
10. Unstable medical condition
11. Any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention
12. Any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
13. Employee or family member of the investigator or study center, or member of the same household as another research participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02750904
Study Brief:
Protocol Section:
NCT02750904