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

Study Overview
=================
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.

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. 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 randomized to 1 of 2 groups. GROUP A: Participants smoke their usual brand of 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 1, 6, 12, and 26 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. GROUP B: 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 1, 6, 12, and 26 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.

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

Conditions
-----------------
Lung Carcinoma

Intervention / Treatment
-----------------
* Procedure: Participants smoke their usual brand of cigarettes for 26 weeks.
* Procedure: Participants will vape electronic cigarettes for 26 weeks.
* Drug: Nicotine Replacement
* Drug: Nicotine Replacement
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting 2021 USPSTF lung cancer screening guidelines (adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years 7) Reports being a daily or non-daily smoker (any self- reported smoking in the past 30 days) Being interested in trying ECs to change CC smoking behavior Willing to have biospecimen samples taken, either in-home using a mobile phlebotomy 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (usual brand cigarettes)<br>Participants smoke their usual brand of 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 1, 6, 12, and 26 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 smoke their usual brand of cigarettes for 26 weeks.<br>* Participants smoke their usual brand of cigarettes for 26 weeks.<br>Drug: Nicotine Replacement<br>* Smoke usual brand of cigarettes<br>* Other names: NRT;Other: Questionnaire Administration<br>* Use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day.<br>|
| Experimental: Group B (e-cigarettes)<br>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 1, 6, 12, and 26 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.<br>* Participants will vape electronic cigarettes for 26 weeks.<br>Drug: Nicotine Replacement<br>* Vape e-cigarettes<br>* Other names: NRT;Other: Questionnaire Administration<br>* Use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes per day | Will be collected using smartphone daily diary data of combustible cigarette use over last 24 hours. | Up to 182 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |