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

Sponsor
Shenzhen Kangning Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05942521
Collaborator
(none)
90
1
3
17.1
5.3

Study Details

Study Description

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:

  1. Whether subconscious extinction intervention would reduce psychological craving and alcohol relapse?

  2. What is the mechanism of subconscious extinction intervention in alcohol dependence?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Very brief extinction
  • Behavioral: Clearly visible extinction
  • Behavioral: Very brief neutral extinction
N/A

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
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Subconscious Memory Extinction on Psychological Craving and Relapse in Patients With Alcohol Dependence and Its Mechanism
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1. [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)

  2. Relapse rate [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 Outcome Measures

  1. Skin conductance level (SCL) [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.

  2. Pupil diameter [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.

  3. Event-relatred potential (ERP) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen Kangning Hospital Shenzhen Guangdong China 518118

Sponsors and Collaborators

  • Shenzhen Kangning Hospital

Investigators

  • Principal Investigator: Xiaojian Jia, Shenzhen Kangning Hospita

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaojian Jia, Professor, Shenzhen Kangning Hospital
ClinicalTrials.gov Identifier:
NCT05942521
Other Study ID Numbers:
  • 2022-K013-01
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaojian Jia, Professor, Shenzhen Kangning Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023