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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT06609902
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 or older
* Have a diagnosis of BD I or II
* Have a diagnosis of tobacco use disorder
* Be engaged in outpatient treatment with a medical provider
* Be on a stable dose of a mood-stabilizing medication
* Smoke an average of at least 5 cigarettes per day for the past 30 days at baseline (based on the Heaviness of Smoking Index(Heatherton et al., 1989))
* Be interested in quitting smoking
* Not currently or in the past 3 months be receiving smoking cessation treatment.
Exclusion Criteria:
* Current psychosis
* Intent to harm oneself with an associated plan and intent to act on suicidal thoughts
* Experiencing severe symptoms of depression and/or hypomania that may warrant a higher level of care (a Patient Health Questionnaire-9 total score ≥ 20(Kroenke et al., 2001) and/or an Altman Self-Rating Mania Scale total score ≥ 6(Altman et al., 1997) will trigger further clinician evaluation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06609902
Study Brief:
Protocol Section:
NCT06609902