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临床试验/NCT02416050
NCT02416050已完成不适用

Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
1
主要终点
mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers

研究概览

简要总结

Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated with relapse to cocaine use.

详细描述

A multivariate model using MRI parameters, craving score, impulsivity score, and neuropsychological testing results will be tested to predict relapse or continuous abstinence three month after cocaine inpatient cessation attempt.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cocaine dependent patient requiring inpatient cessation
  • 18 years old and older
  • giving his/her consent to come back for visits up to three months
  • having a social insurance

排除标准

  • under guardianship
  • restraint hospitalization
  • contraindication to brain MRI
  • pregnant women

结局指标

主要结局

mean difference of fractional anisotropy of the prefrontal cortex (PFC) in patients abstinent from cocaine 3 months after inpatient detoxification compared to relapsers

时间窗: at 3 months

次要结局

  • Among abstinent patients who remain abstinent at three months only: Differences in performance at the stroop test and in mental flexibility during an implicit set shifting task compared to baseline results(at 3 months)
  • Comparisons between patients who remain abstinent from cocaine 3 months after inpatient detoxification and those who relapse(at baseline)
  • Among abstinent patients who remain abstinent at three months only :Differences between baseline and 3 months measures of Diffusion Tensor Imagery (DTI), VBM and DMN(at 3 months)
  • Among abstinent patients who remain abstinent at three months only: Differences in scores of craving (visual scale and OCCS questionnaire) and impulsivity (UPPS)(at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Predicting Relapse After Cocaine Inpatient Cessation | 临床试验