Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer (NCT05144542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
United States140 participantsStarted 2022-03-07
Plain-language summary
This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.
Who can participate
Age range50 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 50-80 years who currently smokes at least 1 or more combustible cigarettes per day OR who is a nondaily smoker (any self-reported smoking in the past 30 days) with a 20 pack-year history.
* Being interested in trying ECs to change CC smoking behavior
* Willing to have biospecimen samples taken, either in-home using a mobile phlebotomoty service, or at an approved collection site
* Have an address where he/she can receive mail
* Being fluent in spoken and written English
* Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
* The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Exclusion Criteria:
* Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
* Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes)
* Unwilling to consent for blood draw
* Evidence of cognitive deficits or instability that would preclude reliable study participation
* Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determine…