NCT05942521

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

June 16, 2023

Last Update Submit

October 12, 2023

Conditions

Alcohol Use Disorder

Keywords

AlcoholCravingExtinction trainingSubconscious

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at 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

    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 Outcomes (3)

  • Skin conductance level (SCL)

    During the intervention period

  • Pupil diameter

    During the intervention period

  • Event-relatred potential (ERP)

    During the intervention period

Study Arms (3)

Very brief extinction

EXPERIMENTAL

Enrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days.

Behavioral: Very brief extinction

Very brief neutral extinction

SHAM COMPARATOR

Enrolled participants would receive very brief neutral extinction for approximately 25 minutes per day for 2 days.

Behavioral: Very brief neutral extinction

Clearly visible extinction

ACTIVE COMPARATOR

Enrolled participants would receive clearly visible extinction therapy for approximately 25 minutes per day for 2 days.

Behavioral: Clearly visible extinction

Interventions

Very brief extinctionBEHAVIORAL

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.

Very brief extinction
Clearly visible extinctionBEHAVIORAL

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.

Clearly visible extinction
Very brief neutral extinctionBEHAVIORAL

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.

Very brief neutral extinction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Acute alcohol dependence withdrawal period;
  • Patients who meet the DSM-â…£ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine);
  • Previous acceptance experienced similar exposure therapy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518118, China

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Xiaojian Jia

    Shenzhen Kangning Hospita

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Jia

CONTACT

+861382379711594205638@qq.com

Qi Wang

CONTACT

+861368881966716981017@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 12, 2023

Study Start

July 20, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)