Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism

October 12, 2023 updated by: Xiaojian Jia, Shenzhen Kangning Hospital

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:

  1. Whether subconscious extinction intervention would reduce psychological craving and alcohol relapse?
  2. What is the mechanism of subconscious extinction intervention in alcohol dependence?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518118
        • Recruiting
        • Shenzhen Kangning Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaojian Jia, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adopt DSM-IV alcohol dependence diagnostic criteria;
  2. Complete detoxification treatment without obvious withdrawal symptoms;
  3. Informed consent, voluntary participation.

Exclusion criteria:

  1. Acute alcohol dependence withdrawal period;
  2. Patients who meet the DSM-Ⅳ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine);
  3. Previous acceptance experienced similar exposure therapy;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Very brief extinction
Enrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days.
Behavioral: Very brief extinction
The very brief extinction presents a very short (33ms) repetitive sequence of alcohol cues, followed by a "masking" stimulus(117ms), which masks the alcohol cues. In the case of repeated exposure to alcohol stimulation, the response to the stimulation is desensitized at the level of unconscious processing.
Sham Comparator: Very brief neutral extinction
Enrolled participants would receive very brief neutral extinction for approximately 25 minutes per day for 2 days.
Behavioral: Very brief neutral extinction
The very brief neutral extinction presents a very short (33ms) repetitive sequence of neutral cues, followed by a "masking" stimulus(117ms), which masks the neutral cues. In the case of repeated exposure to neutral stimulation, the response to the stimulation is desensitized at the level of unconscious processing.
Active Comparator: Clearly visible extinction
Enrolled participants would receive clearly visible extinction therapy for approximately 25 minutes per day for 2 days.
Behavioral: Clearly visible extinction
The clearly visible extinction presents a repetitive sequence of alcohol cues(150ms) without a "masking" stimulus. In the case of repeat exposure to alcohol stimulation, the response to the stimulation is desensitized at the level of conscious processing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and week 1
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
Four week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin conductance level (SCL)
Time Frame: During the intervention period
Thus skin conductance level can serve as a stable and useful index of autonomic arousal in clinical trials. Skin conductance signals are measured via electrodes placed on fingertips, arrange from 0 to 50 uS.
During the intervention period
Pupil diameter
Time Frame: During the intervention period
The pupil diameter is measured by Eyelink 1000 plus eyetracking, Pupil size data are available with every data point collected by the EyeLink 1000 Plus. To evaluate the level of accuracy obtained in pupil size measures, dots between 2.0 and 5.0 mm in diameter were laser printed.
During the intervention period
Event-relatred potential (ERP)
Time Frame: During the intervention period
An ERP is a technique that can be used to assess how the brain is functioning in response to stimulation. Event-related potentials (ERPs) are derived from electroencephalographic (EEG) measurement of neural activity. The 64-channel EEG system from Brain Products company would be used to measure P300, N400, and slow potential.
During the intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Kangning Hospital

Investigators

  • Principal Investigator: Xiaojian Jia, Shenzhen Kangning Hospita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-K013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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