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NCT Number: NCT07808190

HD-tACS for Alcohol Use Disorder

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

Location contact

Min Zhao

CONTACT

[email protected]

64387250

About this study

This study conducted a multi-center randomized clinical controlled trial among individuals with alcohol use disorders, aiming to verify the effectiveness of accelerated HD-tACS in targeting the dorsolateral prefrontal cortex for the treatment of AUD. In particular, it aimed to assess the efficacy of accelerated HD-tACS in reducing alcohol craving and reducing relapse. Eligible patients were randomly divided into the accelerated HD-tACS group and the sham stimulation group in a 1:1 ratio. Clinical and electroencephalogram data were collected at baseline and after the intervention. Additionally, a follow-up assessment of alcohol consumption was conducted for all participants after the intervention ended.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HD-tACS

Device

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.

Sham HD-tACS

Device

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.

Primary outcomes

  1. Change of Craving

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

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

Secondary outcomes

  1. impulsivity

    Time frame: baseline; 1 day after the treatment was completed

    Stop Single Task

  2. Negative reinforcement learning task

    Time frame: baseline; 1 day after treatment was completed

    The negative reinforcement learning task was adopted to evaluate the patients' avoidance-avoidance behaviors and learning. By calculating and modeling, the avoidance-avoidance behavior bias (active avoidance bias ) and the learning rates based on different feedback: learning from successfully avoiding the aversive stimulus; learning from experiencing the aversive stimulus) were constructed.

  3. Changes in Reward Learning

    Time frame: baseline; 1 day after treatment was completed

    Reward Learning Task

  4. Compulsory drinking

    Time frame: baseline; 1 day after treatment was completed

    The Obsessive Compulsive Drinking Scale (OCDS) assesses compulsive thoughts and impulsive behaviors related to alcohol consumption. It consists of 14 items, each rated on a 5-point scale from 0 to 4. Scores ranging from 0 to 14 indicate almost no compulsive drinking characteristics, 15 to 28 indicate obvious compulsive thoughts or impulses, and scores above 29 indicate a significant compulsive drinking pattern with a high risk of relapse.

  5. Depressive state

    Time frame: baseline; 1 day after treatment was completed

    The depression assessment was conducted using the Patient Health Questionnaire - 9 (PHQ-9), which consists of 9 items, each representing a different aspect of depressive symptoms. Each item is scored on a 4-point scale. 0-4 points indicate no depressive symptoms, 5-9 points represent mild depression, 10-14 points indicate moderate depression, and scores above 15 indicate severe depression.

  6. Anxiety state

    Time frame: baseline; 1 day after treatment was completed;

    The anxiety assessment was conducted using the Generalized Anxiety Disorder - 7 (GAD-7) self-rating scale. The core statistical indicator of this scale is the total score. The higher the score, the more severe the anxiety. A total score of 0-4 indicates no anxiety or the anxiety level is not clinically significant; a score of 5-9 represents mild anxiety; a score of 10-14 indicates moderate anxiety; and a score of 15 or above indicates severe anxiety.

  7. Sleeping conditions

    Time frame: baseline; 1 day after the treatment was completed

    The assessment was conducted using the Pittsburgh Sleep Quality Index (PSQI), with the total score ranging from 0 to 21. A higher score indicates poorer sleep quality.

  8. EEG

    Time frame: baseline; 1 day after treatment was completed

    EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power)

  9. EEG

    Time frame: baseline; 1 day after treatment was completed

    change of functional connection of brain area

  10. use of alcohol

    Time frame: 4 weeks after treatment; 12 weeks after treatment

    Simple questionnaire to collect alcohol consumption and drinking frequency.

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Jiang

CONTACT

[email protected]

64387250

Tianzhen Chen

CONTACT

[email protected]

64387250

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Accelerated High-Definition Transcranial Alternating Current Stimulation (HD-tACS) for Alcohol Use Disorder: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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