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NCT05144542Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
135 (actual)
First submitted
18 Nov 2021
Start date
7 Mar 2022
Primary completion date
17 Oct 2025
Lead sponsor
M.D. Anderson Cancer Center
Diseases
Lung cancer
NCT number
NCT05144542

What you commit to

  • Study type: Interventional
  • Participants enrolled: 135
  • From 7 Mar 2022 to the primary completion date, 17 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes)

Other

  • 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
  • Unwilling to consent for blood draw
  • Evidence of cognitive deficits or instability that would preclude reliable study participation
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.