Alcohol Use Disorder (AUD)HITACS-AUDNCT07227545
High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study
A study testing HI-tACS in people with Alcohol Use Disorder (AUD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- HI-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Jiang Du, MD, PhD., +86 021 6490 6315, dujiangdou@163.com
About this study
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.
Read the detailed description
Alcohol use disorder (AUD) has become a major social and public health problem. Persistent alcohol craving, impaired self-control, and abnormalities in decision-making and inhibitory control are important clinical and cognitive features of AUD. High-intensity transcranial alternating current stimulation (HI-tACS) is a non-invasive neuromodulation approach that may have potential therapeutic effects in individuals with AUD. However, its clinical and neurobiological effects in AUD remain unclear. The investigators hypothesize that HI-tACS may reduce alcohol craving and improve self-regulation and cognitive-control functions in individuals with AUD. This one-arm pilot study aims to evaluate the preliminary effects and tolerability of a 2-week course of HI-tACS, using clinical assessments together with electroencephalographic, and magnetic resonance imaging measures to explore potential changes in craving, self-control, risky decision-making, inhibitory control, and related neural activity. This study may provide preliminary clinical and mechanistic evidence for the further development of HI-tACS as a potential intervention for AUD.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- HI-tACS
- Keywords
- High-Intensity Transcranial Alternating Current Stimulation, 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HI-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after completion of the 2-week intervention
Secondary outcomes (9)
The change of drinking urge
Alcohol urge will be assessed using the Alcohol Urge Questionnaire (AUQ). The total score of AUQ ranges from 8 to 56, with higher scores indicating stronger urges to consume alcohol.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of the compulsive drinking behavior
Compulsive drinking behavior will be measured by the short form of the Obsessive-Compulsive Drinking Scale (OCDS). The total score of OCDS ranges from 0 to 40, with higher scores reflecting greater obsessive-compulsive thoughts and behaviors related to alcohol use.
Measured: Baseline, immediately after completion of the 2-week intervention
Side effects of the modulation
Side effects will be assessed using a standardized adverse reaction evaluation form. The presence and severity of stimulation-related adverse reactions will be recorded for each symptom.
Measured: Immediately after each of the 20 HI-tACS sessions during the 2-week intervention period
Change of depressive symptoms.
Depressive symptoms will be measured using the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of anxiety symptoms
Anxiety symptoms will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA-14). The total score ranges from 0 to 56, where higher scores reflect greater anxiety severity.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of the self-control ability
Self-control ability will be measured using the Self-Control Scale (SCS). The total score ranges from 19 to 95, with higher scores of SCS indicating better self-regulation and impulse control.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of the risky decision-making performance
Risky decision-making will be assessed using the Balloon Analogue Risk Task (BART), with task performance and concurrent electroencephalography (EEG) measures related to risk-taking, decision-making, and outcome processing recorded. In addition, the Pig Dice Game will be administered during functional magnetic resonance imaging (fMRI) to assess risk-taking decision-making and associated task-related brain activity. Behavioral and neuroimaging measures derived from these tasks will be used to characterize changes in risk-related decision-making.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of the inhibitory control performance
Inhibitory control will be assessed using the Stop-Signal Task (SST), with task performance evaluated together with concurrent electroencephalography (EEG) measures related to response inhibition and inhibitory control.
Measured: Baseline, immediately after completion of the 2-week intervention
Change of the resting state neural activity.
Resting-state functional magnetic resonance imaging (rsfMRI) will be used to assess intrinsic brain activity and functional connectivity. Resting-state electroencephalography (rsEEG) will be employed to assess spontaneous neural oscillatory activity.
Measured: Baseline, immediately after completion of the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start11 Oct 2026
- Primary completion30 Nov 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 Disorder (AUD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227545
- Sponsor's protocol ID
- JDu-016
- Acronym
- HITACS-AUD
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT07227545
- Acronym / sponsor ID
- HITACS-AUD / JDu-016
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- High-Intensity Transcranial Alternating Current Stimulation, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 11 Oct 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 2025 (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 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.
Detailed description
Alcohol use disorder (AUD) has become a major social and public health problem. Persistent alcohol craving, impaired self-control, and abnormalities in decision-making and inhibitory control are important clinical and cognitive features of AUD. High-intensity transcranial alternating current stimulation (HI-tACS) is a non-invasive neuromodulation approach that may have potential therapeutic effects in individuals with AUD. However, its clinical and neurobiological effects in AUD remain unclear. The investigators hypothesize that HI-tACS may reduce alcohol craving and improve self-regulation and cognitive-control functions in individuals with AUD. This one-arm pilot study aims to evaluate the preliminary effects and tolerability of a 2-week course of HI-tACS, using clinical assessments together with electroencephalographic, and magnetic resonance imaging measures to explore potential changes in craving, self-control, risky decision-making, inhibitory control, and related neural activity. This study may provide preliminary clinical and mechanistic evidence for the further development of HI-tACS as a potential intervention for AUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HI-tACS | Experimental | Device: HI-tACSA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| HI-tACSA 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 |
Primary outcome
The change of alcohol craving
Time frame: Baseline, immediately after completion of the 2-week intervention
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.
9 secondary outcomes
The change of drinking urge
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of the compulsive drinking behavior
Time frame: Baseline, immediately after completion of the 2-week intervention
Side effects of the modulation
Time frame: Immediately after each of the 20 HI-tACS sessions during the 2-week intervention period
Change of depressive symptoms.
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of anxiety symptoms
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of the self-control ability
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of the risky decision-making performance
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of the inhibitory control performance
Time frame: Baseline, immediately after completion of the 2-week intervention
Change of the resting state neural activity.
Time frame: Baseline, immediately after completion of the 2-week intervention
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HI-tACS in people with Alcohol Use Disorder (AUD), 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 6 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: looking for participants now, as of the sponsor's last update on 16 Oct 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. 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 Jiang Du, MD, PhD. (+8602164906315, dujiangdou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of alcohol craving (time frame: Baseline, immediately after completion of the 2-week intervention). 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 16 Oct 2026.