M.D. Anderson Cancer Center
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.
Lung Carcinoma
Participants smoke their usual brand of cigarettes for 26 weeks.
Participants will vape electronic cigarettes for 26 weeks.
Nicotine Replacement
Nicotine Replacement
Questionnaire Administration
Not Applicable
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 |
Estimated Enrollment : | 140 participants |
Masking : | None (Open Label) |
Primary Purpose : | Basic Science |
Official Title : | The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer |
Actual Study Start Date : | March 7, 2022 |
Estimated Primary Completion Date : | April 30, 2025 |
Estimated Study Completion Date : | April 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: E-Cigarettes 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 0, 1, 7, 13, and 27 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. |
Procedure: Participants smoke their usual brand of cigarettes for 26 weeks. Procedure: Participants will vape electronic cigarettes for 26 weeks. Drug: Nicotine Replacement Other: Questionnaire Administration |
Ages Eligible for Study: | 50 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030