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Brief Title: Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
Official Title: The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
Study ID: NCT05144542
Brief 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.
Detailed Description: PRIMARY OBJECTIVE: I. To characterize the effects of switching from combustible cigarettes (CCs) to e-cigarettes (ECs) on product use, product acceptability, and reinforcement among adult daily CC smokers at high risk for lung cancer. SECONDARY OBJECTIVE: I. To characterize the effects of switching from CCs to ECs on biomarkers of inflammation and oxidative stress among adult daily CC smokers at high for lung cancer. EXPLORATORY OBJECTIVES: I. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer. II. To character which factors moderate or mediate the effects of switching from CCs to ECs among CC smokers at high risk for lung cancer. Outline: Participants are assigned to switch to e-cigarettes.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
M D Anderson Cancer Center, Houston, Texas, United States
Name: Jason Robinson, PHD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR