Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1.
Study Overview
Brief Summary
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?
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adopt DSM-IV alcohol dependence diagnostic criteria;
- •Complete detoxification treatment without obvious withdrawal symptoms;
- •Informed consent, voluntary participation.
Exclusion Criteria
- •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;
Arms & Interventions
Very brief extinction
Enrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days.
Intervention: 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.
Intervention: 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.
Intervention: Clearly visible extinction (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1.
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Pupil diameter(During the intervention period)
- Skin conductance level (SCL)(During the intervention period)
- Event-relatred potential (ERP)(During the intervention period)
Investigators
Xiaojian Jia
Professor
Shenzhen Kangning Hospital