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

NCT05144542 | Active Not Recruiting DMC

• 3 other identifiers: 2019-1266NCI-2021-03212R01CA238478
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Cigarettes per day

  Will be collected using smartphone daily diary data of combustible cigarette use over last 24 hours.

  Up to 182 days

Secondary Outcomes (3)

• High-sensitivity C-reactive protein (hs-CRP)

  through study completion, an average of 1 year

• White blood cells (WBC)

  through study completion, an average of 1 year

• 8-epi prostaglandin F2 alpha (8-epi-PGF2a)

  through study completion, an average of 1 year

Study Arms (1)

E-Cigarettes

EXPERIMENTAL

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 will vape electronic cigarettes for 26 weeks.; Drug: Nicotine Replacement

Interventions

Participants will vape electronic cigarettes for 26 weeks. PROCEDURE

Participants will vape electronic cigarettes for 26 weeks.

E-Cigarettes

Nicotine Replacement DRUG

Smoke usual brand of cigarettes

Also known as: Nicotine Replacement Therapy, NRT

E-Cigarettes

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jason Robinson, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 3, 2021
• Study Start: March 7, 2022
• Primary Completion (Estimated): October 17, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)