Emotional Attention Bias Modification and Targeted Memory Reactivation in Alcohol Use Disorder

June 12, 2024 updated by: Shanghai Mental Health Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TMR group
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.
Behavioral: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep
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.
Active Comparator: Control group
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.
Behavioral: Emotional Attention Bias Modification
These patients will receive the treatment of emotional attention bias modification (EABM) without association with the sound S1 and sound S2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
baseline, 1 day after treatment, 2 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in behavioral indicators of positive emotional attention bias towards healthy activity 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 health=RT (negative) - RT (positive) )/SD negative+positive).
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
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.
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
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.
baseline, 1 day after treatment, 2 weeks after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Min Zhao, Shanghai Mental Health Center

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZhao-018

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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