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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01574560
Eligibility Criteria:
Inclusion Criteria (adult):
* Age 18 years or older
* Female
* Smoked ≥ 1 cigarettes per day for at least the past 6 months
* Smoked on 20 days or more in the last month
* Smoking status confirmed via cotinine verification strips
* Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
* Will agree to provide a urine sample at study enrollment
* Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)
* Has a home address
* Has a functioning home phone or cell phone
* Provides written informed consent
Inclusion criteria (child):
* \< or = 10 years of age
* Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child
* Lives in the primary home with the adult study participant at least 5 days a week
Exclusion criteria (adult):
* Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
* Planning to move outside of Minnesota within the next 3 months
* Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
* Currently pregnant
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01574560
Study Brief:
Protocol Section:
NCT01574560