NCT05144542

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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. EXPLORATORY OBJECTIVES: 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. II. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer. III. 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.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Participants will vape electronic cigarettes for 26 weeks.	Participants will vape electronic cigarettes for 26 weeks.
DRUG	Nicotine Replacement	Smoke usual brand of cigarettes
DRUG	Nicotine Replacement	Vape e-cigarettes

Timeline

• Start date: 2022-03-07
• Primary completion: 2026-10-17
• Completion: 2026-10-17
• First posted: 2021-12-03
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States