New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Heavy drinking
研究概览
简要总结
This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.
详细描述
The main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified Stop signal task): a behavioral treatment based on Retrieval-Extinction Learning, through the AAT (Alcohol Approach Avoiding Task) and a treatment based on the neuromodulation of prefrontal cortex through the rTMS (repetitive transcraneal magnetic stimulation) technique. To carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (UPPS) and behvavioral impulsivity (Stop signal task), along with biological measures for polymorphism determinations. Alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for Retrieval-Extinction Learning with AAT and 2:1 (double for the effective technique comparing to placebo/control) for rTMS): Group 1 (N=30): exposure to an alcohol-related video followed by AAT; Group 2 (N=30): neutral-content video followed by AAT; Group 4 (30): active stimulation rTMS (10 Hz) ; Group 4 (N=15): placebo stimulation SAM.
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
- Double (Participant, Investigator)
盲法说明
Double-blinded experiment regarding rTMS treatment is applied to both subjects and investigators. The only non-masked role is for the technician applying either Magstim Rapid or SAM coils to each group of subjects.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 50 years old.
- •A minimum of 28 days of abstinence
- •Consent to participate in the study.
排除标准
- •Subjects with other substance dependence ( with the exception of tobacco)
- •Subjects with a history of brain injury or neurological diseases
- •Denial for study participation
- •Non-spanish speakers
- •rTMS selected participants with be assed in order to discard epilepsy, presence for metallic elements and CNS valves
结局指标
主要结局
Heavy drinking
时间窗: 3 months
Number of days of heavy drinking
Relapses
时间窗: 3 months
Number of relapses
Abstinence
时间窗: 3 months
Days of accumulated abstinence
次要结局
- Self-reported Impulsivity(2 days)
- Polymorphism distribution of CRH and ANK3 genes(2 days)
- Behavioral Impulsivity(2 days)
研究者
Gabriel Rubio Valladolid, MD
Psychiatrist, MD, PhD
Hospital Universitario 12 de Octubre