NCT02334956已完成不适用
Linking fMRI to Mobile Technologies in Addiction Research: Pathophysiology of Executive Deficits, Craving and Substance Use
University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2015年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Coefficient of correlation between inter-regional hemodynamic signals and clinical and neuropsychological data
研究概览
简要总结
120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls will be administered a whole-brain imaging exam. The current research project constitutes a highly novel approach to understanding the pathophysiology of addiction through its combination of neuroimaging with state-of-the-art information concerning the real-time expression of risk factors.
详细描述
- Background : Despite the availability of both pharmacological and psychosocial treatments, most affected individuals will experience addiction as a chronic illness with severe consequences for health outcome. A fundamental challenge to researchers in this domain is therefore to understand the mechanisms leading to relapse. Among the key vulnerability factors associated with addiction chronicity, increasing attention has focused on deficits in executive functions and associated traits (impulsivity, risk taking) that are likely to explain why many individuals with addiction are unable to avoid high-risk contexts or to manage the experience of craving. Research concerning this vulnerability to relapse has been hindered by the manner in which cognitive deficits are traditionally assessed in clinical research. Most commonly, they are thought to represent stable risk factors that show little or no variation within a given individual. However, executive functioning may fluctuate rapidly over time (as does attention, memory, or other key cognitive functions), and therefore comparisons of overall or 'mean' cognitive deficits between healthy and substance-dependent individuals may show no significant differences despite powerful effects of this vulnerability. Therefore, the absence of measurement or characterization of this important relapse mechanism prevents any further research concerning its underlying pathophysiology.
- Purpose : Deficits in executive functioning may explain why many individuals with addiction are unable to avoid high-risk contexts or manage the experience of craving that lead to substance use. The principal objective of this project is to acquire resting state functional Magnetic Resonance Imaging (fMRI) and diffusion tensor imaging (DTI) data on patients with current addiction who will then complete (through a distinct protocol) mobile assessments of daily life executive fluctuations, craving, and substance use.
- Detailed description: 120 individuals with alcohol, cannabis or nicotine dependence as well as healthy controls will be administered a whole-brain imaging exam. The current research project constitutes a highly novel approach to understanding the pathophysiology of addiction through its combination of neuroimaging with state-of-the-art information collected through an independent investigation concerning the real-time expression of risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria patient:
- •Aged 18-64 years
- •Being affiliated to health insurance
- •Having signed an informed consent (later than the day of inclusion and before any examination required by research)
- •Participation in the study MOBICOG for patients with addiction
- •Fulfils diagnostic criteria for one of the following groups:
- •Group A: Patients with current (last 12 months) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) substance addiction (Alcohol / Cannabis / Nicotine); initiation of treatment for addiction within 30 days preceding enrollment in the study; absence of other axis 1 psychiatric disorder currently being treated (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia.
- •Group AM: Patients with current (last 12 months) DSM-IV substance addiction (Alcohol / Cannabis / Nicotine); initiation of treatment for addiction within 30 days preceding enrollment in the study; presence of currently treated unipolar mood disorder (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia.
- •Group AS: Patients currently treated for DSM-IV schizophrenia (last 12 months) with DSM-IV substance addiction (Alcohol / Cannabis / Nicotine); absence of other axis 1 psychiatric disorder currently being treated (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder.
- •Inclusion criteria healthy volunteers:
- •Aged 18-64 years
- •Participation in the study MOBICOG
- •Being affiliated to health insurance
- •Having signed an informed consent (later than the day of inclusion and before any examination required by research)
- •Healthy volunteers without current addiction and with no other currently-treated axis 1 DSM-IV disorder (by psychotherapy or pharmacotherapy); absence of current or lifetime bipolar disorder or schizophrenia
排除标准
- •Presence of a counter-indication for MRI
- •Presence of any health problem preventing travel to the imaging service of the University Hospital
- •Being unable to provide consent to participate
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Patient
Experimental
Patient with addiction
干预措施: Brain MRI (Other)
Control
Experimental
healthy subject
干预措施: Brain MRI (Other)
结局指标
主要结局
Coefficient of correlation between inter-regional hemodynamic signals and clinical and neuropsychological data
时间窗: After the MRI (D2 at 1 month after the inclusion)
次要结局
- Measurements of brain structure, in relation to brain functioning(After the MRI (D2 at 1 month after the inclusion))
- Measurements of daily life functioning through recorded data about craving sensation and executive functioning(After the MRI (D2 at 1 month after the inclusion))
研究者
研究点 (4)
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