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

Running, not enrolling · Not applicable

Conditions studied: Lung Carcinoma

In brief

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.

Key facts

Study ID: NCT05144542
Run by: M.D. Anderson Cancer Center
People needed: 135
Starts: 2022-03-07
Expected to finish: 2026-10-17
Last updated by the study team: 2026-08-05

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.