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

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Meeting National Comprehensive Cancer Network (NCCN) guideline for lung cancer screening (age 55-74, with a smoking history > 30 pack-years; or age > 50, > 20 pack-years, plus one additional risk factor [i.e., factors imparting a > 1.34% risk of lung cancer over the next 6 years from the Tammemagi Lung Cancer Calculator])

• Reports being a daily or non-daily smoker (any self reported smoking in the past 30 days)

• Being interested in trying ECs to change CC smoking behavior

• Willing and able to complete two spirometry sessions (this criterion is waived during coronavirus disease 2019 [COVID-19] pandemic)

• Have an address where he/she can receive mail

• Have a device available to conduct telehealth visit (e.g., smartphone, computer, tablet, internet access)

• Be the only current participant in this study in their household

• Being fluent in spoken and written English

• Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to each in-person research visit

• The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle

Exclusion Criteria:

• Have used ECs on more than 2 days in the past 30 days

• Meet criteria for current major depressive disorder (MDD) or suicidality

• Report more than once weekly of tobacco products other than CCs during the past 30 days

• Report recent (past 30 days), current, or planned (within the next 90 days) involvement in smoking cessation activities

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

• Self-reported bronchial or respiratory infection in the last 14 days (this criterion is waived during COVID-19 pandemic)

• Subject's spirometry forced expiratory volume in 1 second (FEV1) percentage reading < 50 (severe to very severe obstruction) (this criterion is waived during COVID-19 pandemic)

• Unwilling to consent for blood draw

• Evidence of cognitive deficits or instability that would preclude reliable study participation

• Women who are pregnant, breastfeeding, or are not using an acceptable method of birth control (if capable of becoming pregnant)

• Considered by an investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: unwilling or unable to comply with study procedures)