Switching from regular cigarettes to e-cigarettes for 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
This study is testing if older smokers at high risk for lung cancer can benefit from switching from regular cigarettes to e-cigarettes over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05144542 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of older adult smokers switching from combustible cigarettes to electronic cigarettes. The primary objective is to assess product use, acceptability, and reinforcement among daily smokers at high risk for lung cancer. Secondary objectives include evaluating biomarkers of inflammation and oxidative stress, as well as exploring metabolomic changes resulting from the switch. Participants will use their usual brand of cigarettes for 26 weeks before transitioning to e-cigarettes for another 26 weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-80 who smoke at least one combustible cigarette per day or are nondaily smokers with a significant smoking history.
Not a fit: Patients with a history of lung cancer or severe depressive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer smoking alternatives for older adults at high risk for lung cancer.
How similar studies have performed: Other studies have shown varying results regarding the effectiveness of e-cigarettes as a smoking cessation tool, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 50-80 years who currently smokes at least 1 or more combustible cigarettes per day OR who is a nondaily smoker (any self-reported smoking in the past 30 days) with a 20 pack-year history. * Being interested in trying ECs to change CC smoking behavior * Willing to have biospecimen samples taken, either in-home using a mobile phlebotomoty service, or at an approved collection site * Have an address where he/she can receive mail * Being fluent in spoken and written English * Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit. * The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle. Exclusion Criteria: * 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 * 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 * Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. * Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: unwilling or unable to comply with study procedures) * Individuals who reside in an area that is outside of our shipping company or mobile phlebotomty contractors' areas of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline to come in to clinic to provide necessary samples and/or collect study products.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jason Robinson, PHD — M.D. Anderson Cancer Center
- Study coordinator: Jason Robinson, PHD
- Email: nicotinestudy@mdanderson.org
- Phone: 713-792-2265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.