The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Cigarettes per day
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nicotine Replacement (Drug)
结局指标
主要结局
Cigarettes per day
时间窗: Up to 182 days
Will be collected using smartphone daily diary data of combustible cigarette use over last 24 hours.
Combustible Cigarettes Per Day
时间窗: Study Week 1 and Week 27
Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27)
次要结局
- 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)
- Electronic Cigarette Sessions Per Day(Study Week 27)
- Anabasine(Study Week 1 and Week 27)
- Fagerström Test for Cigarette Dependence(Study Week 1 and Week 27)