NCT07227545

Brief Summary

This one-arm pilot study aims to evaluate the preliminary clinical, behavioral, and neurophysiological effects of high-intensity transcranial alternating current stimulation (HI-tACS) in individuals with alcohol use disorder (AUD). Participants will receive HI-tACS and undergo clinical and neurophysiological assessments before and after the intervention.

Trial Health

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Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress5%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

November 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

November 10, 2025

Last Update Submit

September 28, 2026

Conditions

Alcohol Use Disorder (AUD)

Keywords

High-Intensity Transcranial Alternating Current Stimulation, Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • The change of alcohol craving

    Alcohol craving will be measured by the alcohol craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of alcohol craving.

    Baseline, immediately after completion of the 2-week intervention

Secondary Outcomes (9)

  • The change of drinking urge

    Baseline, immediately after completion of the 2-week intervention

  • Change of the compulsive drinking behavior

    Baseline, immediately after completion of the 2-week intervention

  • Side effects of the modulation

    Immediately after each of the 20 HI-tACS sessions during the 2-week intervention period

  • Change of depressive symptoms.

    Baseline, immediately after completion of the 2-week intervention

  • Change of anxiety symptoms

    Baseline, immediately after completion of the 2-week intervention

  • +4 more secondary outcomes

Other Outcomes (2)

  • Individualized Electric Field Simulation

    Baseline, immediately after completion of the 2-week intervention

  • Change of the molecular-level neurochemistry

    Baseline, immediately after completion of the 2-week intervention

Study Arms (1)

HI-tACS

EXPERIMENTAL

A 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.

Device: HI-tACS

Interventions

HI-tACSDEVICE

A 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.

HI-tACS

Eligibility Criteria

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

You may qualify if:

  • Education level of junior high school or above, capable of completing questionnaires and behavioral tests;
  • Aged 18-60 years;
  • Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;
  • No abnormal findings on physical examination;
  • Agree to participate in follow-up assessments;
  • No contraindications for MRI scanning.

You may not qualify if:

  • Have impaired intelligence (Intelligence Quotient\<70);
  • Prior tDCS or TMS treatment within the past 3 months;
  • Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);
  • Severe somatic diseases or major organ dysfunction;
  • Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).
  • Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).
  • Diagnosis of other substance-related and addictive disorders or behavioral addictions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Jiang Du, MD, PhD.

CONTACT

+8602164906315dujiangdou@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2025

First Posted

November 12, 2025

Study Start

September 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)