NCT07808190

Brief Summary

This study aims to systematically explore the effectiveness of accelerated HD-tACS in treating AUD, particularly its efficacy in reducing alcohol craving and preventing relapse in AUD patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 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 Progress27%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

August 31, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

alcohol use disorder

Outcome Measures

Primary Outcomes (1)

  • Change of Craving

    Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs.

    baseline; The 2nd, 4th, 6th, 8th and 10th days during the intervention period; 4 weeks after treatment; 12 weeks after treatment

Secondary Outcomes (10)

  • impulsivity

    baseline; 1 day after the treatment was completed

  • Negative reinforcement learning task

    baseline; 1 day after treatment was completed

  • Changes in Reward Learning

    baseline; 1 day after treatment was completed

  • Compulsory drinking

    baseline; 1 day after treatment was completed

  • Depressive state

    baseline; 1 day after treatment was completed

  • +5 more secondary outcomes

Study Arms (2)

HD-tACS group

EXPERIMENTAL

Using the transcranial electrical stimulation device, with the ring-shaped focusing technology, the current is locked in the target area through a 4\*1 electrode configuration, causing the peak to appear below the central electrode.

Device: HD-tACS

Sham HD-tACS group

SHAM COMPARATOR

Using the transcranial electrical stimulation device, with the ring-shaped focusing technology, the current is locked in the target area through a 4\*1 electrode configuration, causing the peak to appear below the central electrode.

Device: Sham HD-tACS

Interventions

HD-tACSDEVICE

The stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days.

HD-tACS group

The stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days. At the commencement and conclusion of each therapeutic session, a 30-second ramp-up stimulation and a 30-second ramp-down stimulation (totaling 60 seconds) are administered, respectively, while the current output of the device is maintained at zero throughout the intervening interval.

Sham HD-tACS group

Eligibility Criteria

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

You may qualify if:

  • Age range: 18-55 years old, gender not restricted;
  • Meets the DSM-5 diagnostic criteria for alcohol use disorder (moderate to severe);
  • AUDIT score ≥ 16;
  • Baseline score after alcohol cue-induced stimulation is ≥ 3;
  • Completed detoxification treatment before enrollment (moderate to severe), with detoxification duration of ≥ 7 days and ≤ 90 days;
  • Has a primary school education or above, and can understand and complete the research assessment;
  • Voluntarily participated in the study and signed the informed consent form.

You may not qualify if:

  • Currently, there are other substance use disorders (except nicotine);
  • Currently, there are schizophrenia, bipolar disorder or other severe psychotic disorders;
  • Has a history of epilepsy or family history of epilepsy;
  • Has a history of brain trauma, brain surgery or intracranial metal implants;
  • Has received electroconvulsive therapy (ECT), transcranial electrical/magnetic/ultrasound stimulation within the past 6 months;
  • Pregnant or lactating women;
  • Other situations that the researchers consider unsuitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

Location

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

Haifeng Jiang

CONTACT

Tianzhen Chen

CONTACT

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

August 31, 2026

First Posted

September 8, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 8, 2026

Record last verified: 2026-06

Locations