Lung Cancer Clinical Trial
Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
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.
Full 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 randomized to 1 of 2 groups.
GROUP A: Participants smoke their usual brand of cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks.
GROUP B: Participants vape e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks.
Eligibility Criteria
Inclusion Criteria:
Meeting 2021 United States Preventive Services Task Force (USPSTF) lung cancer screening guidelines (adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years
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)
Willing and able to attend in-person clinic sessions on- or off-site to provide biospecimen samples and/or to collect study product
Have an address where he/she can receive mail
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
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
Report more than once weekly of tobacco products other than CCs during the past 30 days
Report recent (past 30 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)
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)
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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