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

Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144542
• Other study ID #: 2019-1266
• Secondary ID: NCI-2021-0321220
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jason Robinson, PHD
• Phone: 713-792-2265
• Email: nicotinestudy[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 assigned to switch to e-cigarettes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Procedure:
• Participants smoke their usual brand of cigarettes for 26 weeks.
Participants smoke their usual brand of cigarettes for 26 weeks.
• Participants will vape electronic cigarettes for 26 weeks.
Participants will vape electronic cigarettes for 26 weeks.

Drug:
• Nicotine Replacement
Smoke usual brand of cigarettes
• Nicotine Replacement
Vape e-cigarettes

Other:
• Questionnaire Administration
Use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes per day	Will be collected using smartphone daily diary data of combustible cigarette use over last 24 hours.	Up to 182 days
Secondary	High-sensitivity C-reactive protein (hs-CRP)	This measure will be collected using blood draws at weeks 0, 6, 12, and 26.	through study completion, an average of 1 year
Secondary	White blood cells (WBC)	This measure will be collected using blood draws at weeks 0, 6, 12, and 26.	through study completion, an average of 1 year
Secondary	8-epi prostaglandin F2 alpha (8-epi-PGF2a)	This measure will be collected using blood draws at weeks 0, 6, 12, and 26.	through study completion, an average of 1 year

External Links

•   MD Anderson Cancer Center