Placebo-controlled Randomized Clinical Trial: tDCS to Prevent Relapse in Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Relapse rate 1 month after discharge
研究概览
简要总结
Despite the system of care in place, patients suffering from an alcohol use disorder (AUD) continue to relapse after their detoxification. For about twenty years, neuromodulations and their mechanisms have been investigated in research in order to apply it as a therapeutic means, in particular direct current transcranial stimulation (tDCS). A previous study found a reduction of relapse rate thanks to the tDCS over the dorsolateral prefrontal cortex (DLPFC; anode on the right and cathode on the left) combined with an ICT.
This clinical trial of 5 sessions of tDCS alone on the DLPFC (20 minutes, anode on the right, cathode on the left). This study follows the same tDCS configuration as the previous one and takes place in the same multidisciplinary detoxification framework in order to see the relevance of using combined tDCS or only tDCS in clinical practice.
详细描述
Hypotheses: For patients with AUD five sessions of tDCS during a detoxification:
- decrease the relapse rate 2 weeks after the treatment;
- decrease patient craving;
- decrease depression and anxiety symptoms;
- strengthen working memory performances.
Context: This is a clinical trial that is part of an alcohol detoxification cure at Unit 72 Addictology of CHU Brugmann. The idea is to add a neuromodulation intervention to the initial management, multidisciplinary and psycho-bio-social. This will be a randomized, sham-controlled, single-blind study.
A total of 60 subjects will be recruited according to the inclusion and exclusion criteria. They will be randomly divided into two groups: the 'active' group (A) that will benefit from tDCS stimulation and the 'sham' group (S).
Measures:
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
- Single (Participant)
盲法说明
sham tDCS protocol: 0 mA but 30s of 2 mA at the start and the end of the session
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
- •French speaker
- •Severe Alcohol Use Disorder requiring alcohol rehabilitation
- •Desire to stay sober for at least the next six months
排除标准
- •Neurological history (epilepsy, head injury, and stroke)
- •Mental confusion or severe cognitive impairment
- •Schizophrenia, chronic psychotic disorders or bipolar type 1 disorder
- •Metal in the brain
- •Pregnancy
- •Having participated in our previous study combining tDCS with ICT
结局指标
主要结局
Relapse rate 1 month after discharge
时间窗: 1-month follow-up
by phone call; more than 60 g of alcohol
Relapse rate 3 months after discharge
时间窗: 3-month follow-up
by phone call; more than 60 g of alcohol
Relapse rate 2 weeks after discharge
时间窗: 2-week follow-up
by phone call; more than 60 g of alcohol
次要结局
- Working memory(at post-intervention (day 22 of hospitalization))
- Craving(at post-intervention (day 22 of hospitalization))
- Depressive symptoms(at post-intervention (day 22 of hospitalization))
- Anxiety state(at post-intervention (day 22 of hospitalization))
研究者
Macha Dubuson
Principal Investigator
Brugmann University Hospital