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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00064961
Eligibility Criteria:
Inclusion Criteria:
* Female aged 45 - 59 at time of enrollment
* African-American or Caucasian; able to confirm racial heritage of past two generations in family
* Postmenopausal
* Smokers (more than 10 cigarettes per day for 1 year or more)
* Written physician approval to participate in program and medical clearance that use of over-the-counter nicotine replacement is not contraindicated based on patient's medical status
Exclusion Criteria
* Men
* Age below 45 or above 59
* Nonsmokers
* Currently in a standardized weight-reduction program or taking medications for weight loss
* History or presence of significant psychiatric illness (e.g., eating disorders, psychosis, psychoactive substance abuse, major depression)
* History of presence of severe physical illness (e.g., renal failure, hepatic failure, cancer, immunological disease)
* Unable to complete long-term study commitment, including anticipating moving out of study area prior to completion of the study
* Unable to confirm racial heritage of past two generations in family.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
59 Years
Study:
NCT00064961
Study Brief:
Protocol Section:
NCT00064961