Investigation of Oxygenation and Blood Flow in the Brain of Smokers and Their Relation to Smoking Abstinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MRI data
研究概览
简要总结
Cerebral oxygenation and blood flow in tobacco use disorder and their relation to smoking abstinence will be measured with MRI" ändern in "Cerebral oxygenation and blood flow in tobacco use disorder
详细描述
In this study, cerebral oxygenation and tobacco-related attentional bias in smokers and non-smokers will be measured with magnetic resonance imaging (MRI).
In this study, the oxygen extraction fraction (OEF), the cerebral blood flow (CBF) and the cerebral metabolic rate of oxygen (CMRO2) are to be measured in smokers and non-smokers using MRI. On the one hand, the influence of chronic smoking (i.e. smokers versus non-smokers) and on the other hand the effect of acute nicotine administration (in smokers) on these parameters will be examined. Furthermore, the influence of these parameters on fMRI results is to be investigated using the example of a stimulus-reaction task. It can be assumed that the OEF does not change through nicotine administration, but differs in smokers and non-smokers and is associated with the strength of tobacco addiction in smokers. CBF and CMRO2 are expected to be reduced in abstinent smokers, but can be normalized by nicotine administration. In this study, 20 smokers and 10 never-smokers will be investigated. Never-smokers will be examined once with MRI and questionnaires, whereas smokers will be examined twice: before and after a smoking break.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 65
- •right-handed
- •normal or correctable eyesight
- •Sufficient ability to communicate with the investigators, to answer questions in oral and written form
- •"Fully Informed Consent"
- •"Written Informed Consent"
- •Group 1 - Smokers: Occasional smoker or tobacco consumption disorder according to DSM 5
- •Group 2 - Never-Smokers: Consumption of less than 20 cigarettes in life
排除标准
- •women: pregnancy
- •Withdrawal of the declaration of consent
- •Exclusion criteria for an MRI scan
- •severe internal, neurological and psychiatric comorbidities
- •Pharmacotherapy with psychoactive substances within the last 14 days
- •Current substance abuse
- •Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)
结局指标
主要结局
MRI data
时间窗: MRI measurement at one day
oxygenation, blood flow and fMRI data; in smokers pre and post smoking; in never-smokers one session
次要结局
未报告次要终点