The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Craving change
研究概览
简要总结
The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.
详细描述
Alcohol abuse and alcohol use disorder are important major health issues in our modern society. However, the treatment of alcohol addiction is currently limited to the treatment of acute withdrawal symptoms, but lacks effective interventions to reduce craving and prevent relapse. In an attempt to improve the treatment of substance dependence, non-invasive neuromodulation has gained attention as a new potential treatment option. The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •a DSM-5 diagnosis of alcohol use disorder
- •age between 18 and 65
- •can return to the research center for successive visits.
排除标准
- •severe cognitive impairment
- •current DSM-5 diagnosis of schizophrenia or another psychotic disorder
- •current other substance abuse (except nicotine)
- •severe organic diseases
- •rTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
结局指标
主要结局
Craving change
时间窗: baseline, after the intervention, and 3 months after the intervention
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.
次要结局
- Change of cognitive function(baseline, after the 2-weeks intervention, and 6 months after the intervention)
- Change of impulsiveness(baseline, after the 2-weeks intervention, and 6 months after the intervention)
- Change of depression(bbaseline, after the 2-weeks intervention, and 6 months after the intervention)
- The abstinence rate after the treatment(after the intervention, and 3 months after the intervention)
- Change of anxiety(baseline, after the 2-weeks intervention, and 6 months after the intervention)
- Change of impulse control(baseline, after the 2-weeks intervention, and 6 months after the intervention)