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临床试验/NCT03508362
NCT03508362Unknown不适用

Neurobiological Substrate of Social Context on Cognitive Control in Drug Users

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit

研究概览

简要总结

The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts.

This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play a critical role in these processes. Addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. These disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex.

For the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ".

This task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. In this task associated with fMRI, it was previously shown that the STN is involved in the control of inhibition. These results confirm our data in the rat, and especially those showing that STN lesions block the ability to stop. The stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users.

In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. Since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure.

There will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). The "stop-signal" task should induce increased activity of the STN that should be modulated by the cocaine-associated cues and by the presence of a peer.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Drug Users Group
  • age between 18 and 65 years
  • regular use of cocaine and crack
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
  • right-handed
  • Healthy volunteers group
  • age between 18 and 65 years
  • non-drug user
  • willing to participate
  • able to give consent
  • not meeting any non-inclusion criteria
  • right-handed

排除标准

  • protected persons
  • lactating women
  • intolerance to noise
  • not a beneficiary of a social security scheme.
  • no signature on the consent form
  • significant psychiatric or neurological disorder
  • known visual impairment and abnormal vision despite correction
  • Contraindication to MRI examination
  • Claustrophobia.
  • Pregnant women

结局指标

主要结局

Functional MRI highlighting a specific modulation of the structures involved in the cognitive control circuit

时间窗: 24 months

Compare in each group the regional brain activity through the measurement of cerebral oxygenation (blood oxygenation level dependent, BOLD). Increased activity in the subthalamic nucleus (STN) in relation to drug use.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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