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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT01408758
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria Tobacco Dependence: Subjects must be currently smoking at least 5 cigarettes per day in the past month, and have smoked 100 cigarettes in their lifetime to qualify for the tobacco VCRT; and will be eligible regardless of their desire to stop smoking.
B. Inclusion Criteria Cholesterol. Subjects must have moderate or moderately high risk for coronary artery disease defined by NCEP (two or more of the following risk factors (male age \> 45 years, female \>55, HDL-C \<40 mg/dl, active smoking, family history of CHD age \< 55 years male or age \< 65 years female) and the average of two LDL-cholesterols \> 100 mg/dl, or the average of two non-HDL cholesterols of 130 mg/dl. Participants will be eligible regardless of desire to lower their cholesterol.
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Exclusion Criteria:
Exclusion Criteria Tobacco and Cholesterol: Participants will be excluded if they are pregnant or lactating, have a psychotic disorder, are unable to make decisions about medications for themselves, are too sick to participate, or have a life expectancy of less than 12 months (e.g., advanced cancer). Participants will be excluded from the tobacco portion of the trial if they have suicidal ideation (score of 1 or more on the suicidal thought or self harm question in the Patient Health Questionnaire (PHQ) 9). Participants will be excluded from the cholesterol portion of the trial if they have had a heart attack or a stroke, if they have diabetes mellitus, aortic aneurysm, peripheral vascular disease, or chronic kidney disease. They will also be excluded if they are already taking a statin medication to lower their cholesterol. They will be excluded if they are unable to take any of the statin medications due to allergy or adverse reaction in the past (before the study starts). They will be excluded from both cholesterol and tobacco portions of study if they do not speak or write English. Participants will be excluded if they do not have access to a personal computer at home (Mac or PC) with broadband internet access (such as cable modem or digital subscriber line \[DSL\] and Firefox, Internet Explorer 7 (or higher), or Safari browser software.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01408758
Study Brief:
Protocol Section:
NCT01408758