Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1.
研究概览
简要总结
In this study, the subconscious memory extinction therapy based on very brief exposure is used to intervene to reduce the alcohol craving of alcohol-dependent patients, prevent relapse, and observe the psychological craving, heart rate, skin conductance, and pupil diameter changes of the patients during the brief exposure extinction. The main questions it aims to answer are:
- Whether subconscious extinction intervention would reduce psychological craving and alcohol relapse?
- What is the mechanism of subconscious extinction intervention in alcohol dependence?
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized in very brief extinction, clearly visible extinction, or very brief neutral extinction. This study will recruit alcohol-dependent participants aged 18-60 in the ward, observe reported subjective scores during the extinction, and record the heart rate, skin conductance, pupil diameter, and ERP changes.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adopt DSM-IV alcohol dependence diagnostic criteria;
- •Complete detoxification treatment without obvious withdrawal symptoms;
- •Informed consent, voluntary participation.
排除标准
- •Acute alcohol dependence withdrawal period;
- •Patients who meet the DSM-Ⅳ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine);
- •Previous acceptance experienced similar exposure therapy;
研究组 & 干预措施
Very brief extinction
Enrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days.
干预措施: Very brief extinction (Behavioral)
Very brief neutral extinction
Enrolled participants would receive very brief neutral extinction for approximately 25 minutes per day for 2 days.
干预措施: Very brief neutral extinction (Behavioral)
Clearly visible extinction
Enrolled participants would receive clearly visible extinction therapy for approximately 25 minutes per day for 2 days.
干预措施: Clearly visible extinction (Behavioral)
结局指标
主要结局
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1.
时间窗: baseline and week 1
Alcohol-specific Visual Analog Scale is a valid measurements of craving for a alcohol. Possible scores range from 0(no craving) to 10 (want to drink imediately). Change= (week 1 score - baseline score)
Relapse rate
时间窗: Four week after intervention
Percentage of participants who relapse by assuming that drinking alcohol on more than 3 days in a month in anunrestricted environment is re-drinking
次要结局
- Pupil diameter(During the intervention period)
- Skin conductance level (SCL)(During the intervention period)
- Event-relatred potential (ERP)(During the intervention period)
研究者
Xiaojian Jia
Professor
Shenzhen Kangning Hospital