Alcohol Use DisorderNCT07808190
HD-tACS for Alcohol Use Disorder
A study testing HD-tACS in people with Alcohol Use Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- HD-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Min Zhao, 64387250, drminzhao@smhc.org.cn
About this study
Official title: Accelerated High-Definition Transcranial Alternating Current Stimulation (HD-tACS) for Alcohol Use Disorder: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- HD-tACS, Sham HD-tACS
- Keywords
- alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham HD-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Craving
Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs.
Measured: 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
Stop Single Task
Measured: baseline; 1 day after the treatment was completed
Negative reinforcement learning task
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.
Measured: baseline; 1 day after treatment was completed
Changes in Reward Learning
Reward Learning Task
Measured: baseline; 1 day after treatment was completed
Compulsory drinking
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.
Measured: baseline; 1 day after treatment was completed
Depressive state
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.
Measured: baseline; 1 day after treatment was completed
Anxiety state
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.
Measured: baseline; 1 day after treatment was completed;
Sleeping conditions
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.
Measured: baseline; 1 day after the treatment was completed
EEG
EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power)
Measured: baseline; 1 day after treatment was completed
EEG
change of functional connection of brain area
Measured: baseline; 1 day after treatment was completed
use of alcohol
Simple questionnaire to collect alcohol consumption and drinking frequency.
Measured: 4 weeks after treatment; 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808190
- Sponsor's protocol ID
- MZhao-028
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated High-Definition Transcranial Alternating Current Stimulation (HD-tACS) for Alcohol Use Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07808190
- Acronym / sponsor ID
- MZhao-028
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD-tACS group | Experimental | Device: HD-tACSUsing 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. |
| Sham HD-tACS group | Sham comparator | Device: Sham HD-tACSUsing 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-tACSThe 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. | Device | HD-tACS group |
| Sham HD-tACSThe 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. | Device | Sham HD-tACS group |
Primary outcome
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.
10 secondary outcomes
impulsivity
Time frame: baseline; 1 day after the treatment was completed
Negative reinforcement learning task
Time frame: baseline; 1 day after treatment was completed
Changes in Reward Learning
Time frame: baseline; 1 day after treatment was completed
Compulsory drinking
Time frame: baseline; 1 day after treatment was completed
Depressive state
Time frame: baseline; 1 day after treatment was completed
Anxiety state
Time frame: baseline; 1 day after treatment was completed;
Sleeping conditions
Time frame: baseline; 1 day after the treatment was completed
EEG
Time frame: baseline; 1 day after treatment was completed
EEG
Time frame: baseline; 1 day after treatment was completed
use of alcohol
Time frame: 4 weeks after treatment; 12 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Related trials for Alcohol Use Disorder
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Zhao study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tACS in people with Alcohol Use Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haifeng Jiang (64387250, dragonjhf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.