Alcohol Use DisorderNCT06457113
Emotional Attention Bias Modification and Targeted Memory Reactivation in Alcohol Use Disorder
A study testing Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep and Emotional Attention Bias Modification in people with Alcohol Use Disorder, run by Shanghai Mental Health Center.
Trial summary
Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep and Emotional Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Jun 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-55 years; Meets the diagnostic criteria for Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013); Alcohol withdrawal period of less than 6 months; Normal vision and hearing, or corrected to normal; Agrees to participate in the study and is able to cooperate to complete the experiment.
Who cannot join
- Acute alcohol withdrawal period: Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score ≥ 9; History of organic brain diseases or brain trauma; History of seizures, other neuropsychiatric disorders, or family history of psychiatric disorders; Presence of substance abuse/addiction other than alcohol (excluding nicotine addiction).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Augmentation of Emotional Attention Bias Modification With Targeted Memory Reactivation for Alcohol Use Disorder (AUD)
Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification.
Read the detailed description
This protocol uses TMR during REM sleep to strengthen associative memories generated by emotional attention bias modification (EABM), an effective treatment for controlling craving levels in patients with Alcohol Use Disorder (AUD). EABM involves exposure to negative emotional words (e.g., frustrated, inferior) associated with alcohol-related cues and positive emotional words (e.g., successful, confident) associated with healthy lifestyle cues. The goal is to reduce alcohol-related cue positive emotional attention bias (EABs). In EABM training, alcohol-related cues and healthy activity (e.g., exercising, reading, playing musical instruments) images are always paired with negative words and positive words, respectively. The TMR group receives the EABM protocol with auditory cue feedback (sound S1-Alcohol; sound S2-Healthy Life); the control group receives the EABM protocol without auditory cue feedback. All patients will perform EABM every evening and will be exposed to sounds S1 and S2 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the EAB and craving levels of AUD will be conducted before and after (with a 2-week follow-up). The investigators hypothesize that patients treated with EABM and who are exposed during REM sleep to a sound that had previously been associated with the new negative memory of alcohol and the positive memory of a healthy lifestyle (TMR group) will have more reduced EAB and craving levels compared to participants exposed to the same, but non-associated, sound during REM sleep (control group).
- Conditions
- Alcohol Use Disorder
- Being tested
- Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep, Emotional Attention Bias Modification
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Attention Bias Modification and Targeted memory reactivation during REM sleepBehavioural
Emerging evidence shows that REM sleep is crucial for processing emotional memories and consolidating implicit memories. By using targeted memory reactivation (TMR), a known method where sound S1 and sound S2 are associated with a waking experience(i.e.negative emotional words is associated with alcohol-related cues and positive emotional words is associated with healthy lifestyle cues) and strengthened during REM sleep, the investigators aim to augment the control of craving levels in patients with Alcohol Use Disorder.
Emotional Attention Bias ModificationBehavioural
These patients will receive the treatment of emotional attention bias modification (EABM) without association with the sound S1 and sound S2.
| Study group | Role | What they receive |
|---|---|---|
| TMR group | Experimental | Patients will receive a sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). They will also receive the sound S1 and sound S2 during REM sleep. Receives: Behavioral: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep |
| Control group | Active comparator | Patients will not receive the sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). During REM sleep, they will receive the same sound as the experimental group (S1 and S2) under the same conditions. Receives: Behavioral: Emotional Attention Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in behavioral indicators of positive emotional attention bias towards alcohol-related cues
Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D alcohol=RT (negative) - RT (positive) )/SD negative+positive).
Measured: baseline, 1 day after treatment, 2 weeks after treatment
Secondary outcomes (3)
Changes in behavioral indicators of positive emotional attention bias towards healthy activity cues
Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D health=RT (negative) - RT (positive) )/SD negative+positive).
Measured: baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Scale
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
Measured: baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Mood Scale
evaluate all participants' mood assessed by Visual Analog Scales (VAS). The scores ranges from 0 to 10, where 0 indicates the absence of the emotion and 10 indicates the emotion is extremely intense.
Measured: baseline, 1 day after treatment, 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457113
- Sponsor's protocol ID
- MZhao-018
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Emotional Attention Bias Modification With Targeted Memory Reactivation for Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT06457113
- Acronym / sponsor ID
- MZhao-018
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification.
Detailed description
This protocol uses TMR during REM sleep to strengthen associative memories generated by emotional attention bias modification (EABM), an effective treatment for controlling craving levels in patients with Alcohol Use Disorder (AUD). EABM involves exposure to negative emotional words (e.g., frustrated, inferior) associated with alcohol-related cues and positive emotional words (e.g., successful, confident) associated with healthy lifestyle cues. The goal is to reduce alcohol-related cue positive emotional attention bias (EABs). In EABM training, alcohol-related cues and healthy activity (e.g., exercising, reading, playing musical instruments) images are always paired with negative words and positive words, respectively. The TMR group receives the EABM protocol with auditory cue feedback (sound S1-Alcohol; sound S2-Healthy Life); the control group receives the EABM protocol without auditory cue feedback. All patients will perform EABM every evening and will be exposed to sounds S1 and S2 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the EAB and craving levels of AUD will be conducted before and after (with a 2-week follow-up). The investigators hypothesize that patients treated with EABM and who are exposed during REM sleep to a sound that had previously been associated with the new negative memory of alcohol and the positive memory of a healthy lifestyle (TMR group) will have more reduced EAB and craving levels compared to participants exposed to the same, but non-associated, sound during REM sleep (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMR group | Experimental | Behavioral: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleepPatients will receive a sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). They will also receive the sound S1 and sound S2 during REM sleep. |
| Control group | Active comparator | Behavioral: Emotional Attention Bias ModificationPatients will not receive the sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). During REM sleep, they will receive the same sound as the experimental group (S1 and S2) under the same conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-55 years; Meets the diagnostic criteria for Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013); Alcohol withdrawal period of less than 6 months; Normal vision and hearing, or corrected to normal; Agrees to participate in the study and is able to cooperate to complete the experiment.
Key exclusion criteria (1 listed)
- Acute alcohol withdrawal period: Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score ≥ 9; History of organic brain diseases or brain trauma; History of seizures, other neuropsychiatric disorders, or family history of psychiatric disorders; Presence of substance abuse/addiction other than alcohol (excluding nicotine addiction).
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 |
|---|---|---|
| Emotional Attention Bias Modification and Targeted memory reactivation during REM sleepEmerging evidence shows that REM sleep is crucial for processing emotional memories and consolidating implicit memories. By using targeted memory reactivation (TMR), a known method where sound S1 and sound S2 are associated with a waking experience(i.e.negative emotional words is associated with alcohol-related cues and positive emotional words is associated with healthy lifestyle cues) and strengthened during REM sleep, the investigators aim to augment the control of craving levels in patients with Alcohol Use Disorder. | Behavioural | TMR group |
| Emotional Attention Bias ModificationThese patients will receive the treatment of emotional attention bias modification (EABM) without association with the sound S1 and sound S2. | Behavioural | Control group |
Primary outcome
Changes in behavioral indicators of positive emotional attention bias towards alcohol-related cues
Time frame: baseline, 1 day after treatment, 2 weeks after treatment
Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D alcohol=RT (negative) - RT (positive) )/SD negative+positive).
3 secondary outcomes
Changes in behavioral indicators of positive emotional attention bias towards healthy activity cues
Time frame: baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Scale
Time frame: baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Mood Scale
Time frame: baseline, 1 day after treatment, 2 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
Min Zhao study chair
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep and Emotional Attention Bias Modification in people with Alcohol Use Disorder, run by Shanghai Mental Health Center.
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 1 inclusion and 1 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Min Zhao, PhD (021-54252689, drminzhao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in behavioral indicators of positive emotional attention bias towards alcohol-related cues (time frame: baseline, 1 day after treatment, 2 weeks after treatment). 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 13 Jun 2024.