Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer

Launched by M.D. ANDERSON CANCER CENTER · Nov 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of switching from regular cigarettes to electronic cigarettes (e-cigarettes) for older adults who smoke and are at high risk for lung cancer. The goal is to understand the potential risks and benefits of using e-cigarettes, which deliver nicotine through heated vapor, instead of traditional cigarettes. The findings may help health authorities, like the Food and Drug Administration (FDA), make informed decisions about e-cigarettes and improve public health.

To participate, you need to be between 50 and 80 years old and currently smoke at least one regular cigarette a day or have a history of smoking. You should be interested in trying e-cigarettes to reduce your smoking and be comfortable with providing blood samples. It's important to note that those with certain mental health conditions or unstable medical issues, as well as pregnant or breastfeeding individuals, cannot join the study. Participants will have the opportunity to contribute to important research while receiving support and guidance throughout the process.

Gender

ALL

Eligibility criteria

• 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 determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
• • Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: unwilling or unable to comply with study procedures)
• • Individuals who reside in an area that is outside of our shipping company or mobile phlebotomty contractors' areas of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline to come in to clinic to provide necessary samples and/or collect study products.