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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT04132232
Eligibility Criteria:
Inclusion Criteria:
i. Age 16-45
ii. Singleton gestation
iii. Gestational age at enrollment \<24 weeks
iv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST ≥4
v. Cigarette smoker using ≥10 cigarettes/day interested in quitting
Exclusion criteria:
i. Known or suspected fetal growth restriction at enrollment
ii. Known fetal anomaly, aneuploidy, or demise
iii. Not interested in smoking cessation or reduction during pregnancy
iv. E-cigarette use
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
45 Years
Study:
NCT04132232
Study Brief:
Protocol Section:
NCT04132232