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临床试验/NCT05292547
NCT05292547已完成不适用

Substance Misuse To Psychiatric Disorders-Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月1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
20
试验地点
2
主要终点
Severity of Dependence

研究概览

简要总结

This study is to explore if repetitive transcrinal magnetic stimulation (rTMS) with different stimulation schedules will be equally effective in reducing carving, frequency of cannabis use, and the severity of cannabis use disorder in participants suffering from cannabis use disorder (CUD).

The investigators assume the hypotheses as:

  1. Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use.
  2. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.

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

入选标准

  • Able to read and communicate in English and/or Chinese SToP-C-rTMS x CUD
  • Able to give informed consent
  • Using cannabis or marijuana as the primary psychoactive substance of abuse
  • Diagnosed with Cannabis Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)

排除标准

  • Age <18 years old
  • Unable to read English or Chinese
  • Unable to give informed consent
  • Had been diagnosed with the following disorders, including neurodevelopmental disorders, DSM-5 defined substance use disorder greater than moderate in severity, and neurocognitive disorders
  • Contra-indicated to have rTMS, including subjects with electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.), with metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.), pregnant, with any known or history of neurological conditions including cerebral vascular accidents, epilepsy, brain tumor or space occupying lesion, poorly controlled or unstable diabetes mellitus, and receiving unstable dose(s) of antipsychotics, antidepressants, benzodiazepines and/or anticonvulsants in the past 6 months

结局指标

主要结局

Severity of Dependence

时间窗: 12 months

A change in scorings measured by the Severity of Dependence Scale (ranges from a minimum of 5 to a maximum of 20) from baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS

A change in amount of cannabis use

时间窗: 12 months

Subject's self-report on the amount of cannabis use (in terms of number of joints per day) at baseline to the amount of use at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS

A change in frequency of Cannabis Use

时间窗: 12 months

Subject's self-repot on the frequency of cannabis use (in terms of number of times of use per day and/or per week) at baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS

Craving

时间窗: 12 months

A change in scorings measured by Marijuana Craving Questionnaire (ranges from a minimum of 17 to a maximum of 119) from baseline to to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS

Severity of Cannabis Use Disorder

时间窗: 12 months

A change in severity of cannabis use disorder measured by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with severity ranges from 0 to 11 (maximum severity) from baseline to that at 2nd week, 4th week, 5th week, 3rd month, 6th month and 12-month post-treatment with rTMS

次要结局

  • Level of Depression(12 months)
  • Level of Anxiety(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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