NCT05738174招募中不适用
Theta Burst Zur Behandlung Der Alkoholabhängigkeit
Berthold Langguth, MD, Ph.D.2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Craving visual analoge scale
研究概览
简要总结
This is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (TBS).
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
- •alchohol dependence according to ICD-10 (F10.2)
- •desire to reduce or abstain from alcohol drinking
- •male or female
- •18-65 years
- •residency in Germany, German speaking
- •written informed consent
排除标准
- •contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker)
- •relevant neurological or internistic diseases according to study investigator
- •treatment with TMS in the past
- •participation in other trials during treatment
- •pregnancy or breatfeeding
- •positive breath test for alcohol
- •legal care and placement in a psychiatric hospital
- •co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene
- •acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (<1 month)
- •severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder)
- •patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)
结局指标
主要结局
Craving visual analoge scale
时间窗: one week
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
次要结局
- relapse (number of patients with alcohol relapse)(13 weeks)
- abstinence confidence(13 weeks)
- Craving visual analoge scale(13 weeks)
- heavy drinking days(13 weeks)
- World Health Organisation quality of life bref(13 weeks)
- degree of dependence(13 weeks)
- Fagerström Test for Nicotine Dependence(13 weeks)
- major depression inventory(13 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Prof. Dr.
University of Regensburg
研究点 (2)
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