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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
140
Participants smoke their usual brand of cigarettes for 26 weeks.
Participants will vape electronic cigarettes for 26 weeks.
Smoke usual brand of cigarettes
Vape e-cigarettes
Use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day.
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGCigarettes per day
Will be collected using smartphone daily diary data of combustible cigarette use over last 24 hours.
Time frame: Up to 182 days
High-sensitivity C-reactive protein (hs-CRP)
This measure will be collected using blood draws at weeks 0, 6, 12, and 26.
Time frame: through study completion, an average of 1 year
White blood cells (WBC)
This measure will be collected using blood draws at weeks 0, 6, 12, and 26.
Time frame: through study completion, an average of 1 year
8-epi prostaglandin F2 alpha (8-epi-PGF2a)
This measure will be collected using blood draws at weeks 0, 6, 12, and 26.
Time frame: through study completion, an average of 1 year
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