NCT06457113

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 8, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    baseline, 1 day after treatment, 2 weeks after treatment

  • Change of Craving assessed by Visual Analog Scale

    baseline, 1 day after treatment, 2 weeks after treatment

  • Change of Craving assessed by Visual Analog Mood Scale

    baseline, 1 day after treatment, 2 weeks after treatment

Study Arms (2)

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.

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.

Behavioral: Emotional Attention Bias Modification

Interventions

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.

TMR group

These patients will receive the treatment of emotional attention bias modification (EABM) without association with the sound S1 and sound S2.

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Min Zhao

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

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
SPONSOR

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

June 30, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share