跳至主要内容
临床试验/NCT03748875
NCT03748875Unknown不适用

The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents

Shanghai Mental Health Center0 个研究点目标入组 200 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
craving change

研究概览

简要总结

Amphetamine-type stimulants (ATSs) have become the most important medical issue as well as the social problem. Compared with traditional drugs, ATS are highly neurotoxin and can induce cognitive deficit and psychotic symptoms. Due to lack of efficient medical treatment, psychotherapy and behavioral interventions are the main treatment strategies so far. Mindful-based relapse prevention (MBRP) which combined mindfulness with relapse prevention skills, as a novel intervention, has been widely used in prevent craving and relapse among addictions. While the current research of MBRP mechanism focus on emotion regulation circuit, and there was no study to explore the impulsive circuit, which is the important factor that induce the addiction and relapse. However, there was no report about the influence of MBRP on Prefrontal-striatal circuits. Based on the previous results, the proposed study will focus on evaluating the mechanism of MBRP on prefrontal-striatal circuits, neuropsychological tests and functional MRI will be used to investigate the neurobiological mechanism of MBRP on prefrontal-striatal circuits and related impulsive behaviors.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-45 years old, male or female, with 9 years of education or above, can cooperate with the completion of the questionnaire evaluation;
  • Comply with DSM-V diagnostic criteria for amphetamine-based addiction;
  • The previous use of amphetamines for not less than 1 year (at least once a week);
  • Vision and hearing are normal, or in the normal range after correction. No contraindications for magnetic resonance imaging;
  • agree to cooperate with the completion of follow-up evaluation;
  • The Mindfulness Attention Awareness Scale score is greater than 50 points.

排除标准

  • Severe cognitive dysfunction, such as history of head trauma, cerebrovascular disease, epilepsy, etc., drugs used to promote cognitive function in the last 6 months; intellectual impairment IQ<70;
  • There have been other abuse or dependence of psychoactive substances in the past 5 years (excluding nicotine); 100 healthy controls have been publicly collected by the public. Exclude serious physical illness and mental damage. through
  • SCID clinical interviews exclude family history of mental disorders and psychosis, no history of substance abuse (except nicotine).

结局指标

主要结局

craving change

时间窗: change from baseline, 4,8,12,27and 52 weeks

craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving

impulsiveness change

时间窗: baseline,4,8,12,27and 52 weeks

impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1,Occasionally = 2,Often = 3,Almost Always/Always = 4. Assessment is indicated by the total score added together.

functional connectivity change between prefrontal cortex and striatum

时间窗: baseline, 8 and 12weeks

functional connectivity between prefrontal cortex and striatum will be measured by fMRI

次要结局

  • cognitive function improvement(baseline,4,8,12,27and 52 weeks)
  • addiction severity change(baseline,4,8,12,27and 52 weeks)
  • depression level change(baseline,4,8,12,27and 52 weeks)
  • anxiety level change(baseline,4,8,12,27and 52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

相似试验