Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Reduction of alcohol use in post-treatment at week 12
研究概览
简要总结
Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.
详细描述
Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues.
The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.
Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).
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, Care Provider, 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
- •Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification.
- •Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria)
- •Aged between 18 and 65 years
- •Comorbidity with anxiety disorders and depressive disorders is allowed
- •Patients must be illegal drug free for 3 weeks at beginning of trial
- •Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time.
- •Patients must be reachable for follow-up
排除标准
- •Previous neurological conditions (epilepsy, traumatic brain injury, stroke)
- •Present delirium, confusion or severe cognitive disorder
- •Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder.
- •Any severe, life-threatening disorders
- •High suicidal risk
- •Specific contraindications for tDCS: metallic plates in the head
- •Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.
结局指标
主要结局
Reduction of alcohol use in post-treatment at week 12
时间窗: 12 weeks post-rehab
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of alcohol use in post-treatment at week 2
时间窗: é weeks post-rehab
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of alcohol use in post-treatment at week 4
时间窗: 4 weeks post-rehab
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of the relapse rate in post-treatment at week 2
时间窗: 2 weeks post-rehab
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 4
时间窗: 4 weeks post-rehab
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 24
时间窗: 24 weeks post-rehab
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 12
时间窗: 12 weeks post-rehab
Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of alcohol use in post-treatment at week 24
时间窗: 24 weeks post-rehab
Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
次要结局
- response inhibition at day 22(at post-intervention (day 22 of hospitalization))
- Cue reactivity (alcohol verbal fluency) at day 22(at post-intervention (day 22 of hospitalization))
- Cue reactivity (valence) at day 22(at post-intervention (day 22 of hospitalization))
- Cue reactivity (arousal) at day 22(at post-intervention (day 22 of hospitalization))
- response inhibition at day 12(at baseline (day 10 of hospitalization))
- Cue reactivity (attractiveness) at day 22(at post-intervention (day 22 of hospitalization))
- Cue reactivity at day 22(at post-intervention (day 22 of hospitalization))
- Cue reactivity (alcohol verbal fluency) at day 12(at baseline (day 12 of hospitalization))
研究者
Xavier NOËL
Research Associate at the F.R.S/FNRS
Brugmann University Hospital