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临床试验/NCT03502486
NCT03502486Unknown不适用

The Effects of Acute Bouts of Moderate and Intense Exercise on Alcohol and Cocaine Craving - an fNIRS Study

University of Basel2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Stroop test accuracy

研究概览

简要总结

The study is a crossover randomised controlled trial. Alcohol or cocaine dependent participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in a randomised order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images, and self-report craving levels. During the Stroop test and film viewing, participants' neural activity will be measured via functional near-infrared spectroscopy

详细描述

The aim of this study is to examine whether, following acute exercise bouts at moderate and high intensities, reduced craving and increased inhibitory control can be observed in alcohol or cocaine dependent individuals. As the focus of this study is the potential of exercise to be integrated into treatment, individuals in treatment for their dependence, who have been abstinent for a short period, will be recruited.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For alcohol or cocaine dependent participants:
  • meeting three or more of the DSM-IV criteria for substance dependence (as determined by treating physician);
  • minimum of 20 days and maximum of 40 days abstinence from substance of dependence;
  • able to understand and complete the informed consent;
  • able to travel to study site independently, as confirmed by the treating psychiatrist;
  • assessed for physical and mental fitness by treating physician and cleared to take part in the study;
  • fewer than 3 hours of physical exercise or sport per week;
  • For healthy controls:
  • fewer than 3 hours of physical exercise or sport per week;
  • no history of problematic alcohol or illicit drug consumption.

排除标准

  • Pregnancy
  • Questionable findings during resting ECG screen

结局指标

主要结局

Stroop test accuracy

时间窗: Change from Baseline after 20 minute acute condition

Accuracy on Stroop test

Stroop test reaction time

时间窗: Change from Baseline after 20 minute acute condition

Reaction time on Stroop test

Self-reported craving

时间窗: Change from Baseline after 20 minute acute condition

Sum score on Alcohol Craving Questionnaire Short Form (scale range 12 to 84, higher scores representing greater craving) or Cocaine Craving Questionnaire - Brief (scale range 10 to 70, higher scores representing greater craving)

Cerebral oxygenation in prefrontal cortex

时间窗: Change from Baseline after 20 minute acute condition

Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Flora Colledge

Postdoctoral researcher

University of Basel

研究点 (2)

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