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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Drug: Nicotine Replacement

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 characterize 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.

Participants vape study-provided 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 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Cigarettes; Participants vape study-provided 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 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study.	Drug: Nicotine Replacement; Vape e-cigarettes; Other Names: Nicotine Replacement Therapy; NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combustible Cigarettes Per Day	Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)	Study Week 1 and Week 27

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electronic Cigarette Sessions Per Day	Mean electronic cigarette sessions per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)	Study Week 27
Anabasine	Geometric means of the natural log of urine anabasine levels collected at study week 1 (end of combustible cigarette smoking baseline) and week 27 (end of electronic cigarette provision).	Study Week 1 and Week 27
Fagerström Test for Cigarette Dependence	The Fagerström Test for Cigarette Dependence (FTCD) is a measure of cigarette dependence. Scores range from 0 to 10, with higher scores indicating greater dependence.	Study Week 1 and Week 27

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jason Robinson, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): October 17, 2025
• Study Completion (Estimated): October 17, 2026

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Therapeutics; Drug Therapy; Nicotine Replacement Therapy
• Other Study ID Numbers: 2019-1266 (Other Identifier: M D Anderson Cancer Center); NCI-2021-03212 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA238478 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No