Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in overall levels of peripheral inflammatory cytokines
研究概览
简要总结
The objective of this study is to examine the cognitive, immunological, and neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes. The central hypothesis of this study is that this transition will be accompanied by a decrease in peripheral inflammation, which will lead to significant changes in the neurocircuitry underlying interoception and appetite.
详细描述
Participants who are current cigarette smokers will be randomly assigned to either the experimental or control groups. Following a baseline psychiatric assessment session, subjects will return to the study center for two to three additional follow-up visits.
During the second visit, all subjects will undergo a functional magnetic resonance imaging (fMRI) scanning session, during which they will perform a series of functional neuroimaging tasks designed to examine the neural substrates involved in visceral interoception and eating behavior. Prior to the start of the scan session, blood samples will be collected from each subject, for the measurement of bio-markers related to nicotine use and peripheral inflammation. After the end of the second visit, subjects within the experimental group will be asked to switch from combustible to electronic cigarettes. Subjects within the control group will continue to smoke combustible cigarettes as previously.
During the third visit, which will follow two to eight weeks after the second visit, all subjects will provide a second blood sample and complete a second fMRI scan session. Both groups of participants will complete the same fMRI tasks as they did during the second visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current cigarette smokers who have smoked for at least one year
- •right-handed adults
- •able to provide written informed consent
排除标准
- •use of anticonvulsant, stimulant, or antipsychotic medication for 3 weeks prior to scanning
- •any medical conditions or medications likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases
- •any history of drug (other than nicotine) or alcohol abuse within 1 year
- •current pregnancy or breast feeding
- •primary language other than English
- •meeting general MRI exclusion criteria such as magnetic implants or claustrophobia
- •Past history of any axis I psychiatric condition, other than major depressive disorder and post-traumatic stress disorder
- •Current major depression or post-traumatic stress disorder
- •Serious suicidal ideation
研究组 & 干预措施
Tobacco Cigarette Group
This group will not receive an electronic cigarette and will continue to smoke combustible tobacco cigarettes as previously.
干预措施: Tobacco Cigarette (Other)
Electronic Cigarette Group
This group will receive an electronic cigarette to use for the duration of the study.
干预措施: Electronic Cigarette (Other)
结局指标
主要结局
Change in overall levels of peripheral inflammatory cytokines
时间窗: 2-8 weeks
A composite measure of change in overall blood serum levels of multiple peripheral cytokines (CRP, TNF-alpha, sVCAM, IL-1RA, IL-6) between study visits two and three.
次要结局
- Change in cotinine levels(2-8 weeks)
- Change in BOLD fMRI response during interoception(2-8 weeks)
- Change in BOLD fMRI response to food pictures(2-8 weeks)
- Frequency of Electronic Cigarette use(2-8 weeks)
- Frequency of Tobacco Cigarette use(2-8 weeks)
- Change in Blood Oxygen Level-Dependent (BOLD) resting state functional connectivity during fMRI(2-8 weeks)
- Change in exhaled Carbon Monoxide(2-8 weeks)