Alcohol Use DisorderNCT05942521
Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
A study testing Very brief extinction, Clearly visible extinction and Very brief neutral extinction in people with Alcohol Use Disorder, run by Shenzhen Kangning Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Very brief extinction, Clearly visible extinction and Very brief neutral extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adopt DSM-IV alcohol dependence diagnostic criteria;
- Complete detoxification treatment without obvious withdrawal symptoms;
- Informed consent, voluntary participation.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Xiaojian Jia, +8613823797115, 94205638@qq.com
Qi Wang, +8613688819667, 16981017@qq.com
About this study
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?
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Very brief extinction, Clearly visible extinction, Very brief neutral extinction
- Keywords
- Alcohol, Craving, Extinction training, Subconscious
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very brief extinctionBehavioural
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.
Clearly visible extinctionBehavioural
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.
Very brief neutral extinctionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Very brief extinction | Experimental | Enrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days. Receives: 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. Receives: 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. Receives: Behavioral: Clearly visible extinction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Four week after intervention
Secondary outcomes (3)
Skin conductance level (SCL)
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.
Measured: During the intervention period
Pupil diameter
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.
Measured: During the intervention period
Event-relatred potential (ERP)
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.
Measured: During the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start20 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojian Jia, Shenzhen Kangning Hospital
- Investigators
- Xiaojian Jia, Principal investigator, Shenzhen Kangning Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942521
- Sponsor's protocol ID
- 2022-K013-01
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
- ClinicalTrials.gov ID
- NCT05942521
- Acronym / sponsor ID
- 2022-K013-01
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Craving, Extinction training, Subconscious
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Very brief extinction | Experimental | Behavioral: Very brief extinctionEnrolled participants would receive very brief extinction approximately 25 minutes per day for 2 days. |
| Very brief neutral extinction | Sham comparator | Behavioral: Very brief neutral extinctionEnrolled participants would receive very brief neutral extinction for approximately 25 minutes per day for 2 days. |
| Clearly visible extinction | Active comparator | Behavioral: Clearly visible extinctionEnrolled participants would receive clearly visible extinction therapy for approximately 25 minutes per day for 2 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adopt DSM-IV alcohol dependence diagnostic criteria;
- Complete detoxification treatment without obvious withdrawal symptoms;
- Informed consent, voluntary participation.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very brief extinctionThe 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. | Behavioural | Very brief extinction |
| Clearly visible extinctionThe 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. | Behavioural | Clearly visible extinction |
| Very brief neutral extinctionThe 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. | Behavioural | Very brief neutral extinction |
Primary outcome
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
3 secondary outcomes
Skin conductance level (SCL)
Time frame: During the intervention period
Pupil diameter
Time frame: During the intervention period
Event-relatred potential (ERP)
Time frame: During the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojian Jia principal investigator
Shenzhen Kangning Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very brief extinction, Clearly visible extinction and Very brief neutral extinction in people with Alcohol Use Disorder, run by Shenzhen Kangning Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian Jia (+8613823797115, 94205638@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1. (time frame: baseline and week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.