Alcohol Use Disorder (AUD)NCT06867224
Transcranial Ultrasound Stimulation as a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.
A study testing Active TUS-vmPFC in people with Alcohol Use Disorder (AUD) and Transcranial Ultrasound Stimulation, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. Utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Transcranial Ultrasound Stimulation
- What is being tested?
- Active TUS-vmPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 1 Jan 2027
- 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
- No healthy volunteers
- 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);
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
About this study
This study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. Utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a sham treatment.
Read the detailed description
As a major global public health issue, the core therapeutic goal of alcohol use disorder (AUD) is to reduce alcohol craving and prevent relapse. In recent years, transcranial ultrasound stimulation (TUS) has emerged as a reliable non-invasive neuromodulation technique. Studies have shown that abnormalities in neural activity and structure in the ventromedial prefrontal cortex (vmPFC) of AUD are closely associated with alcohol craving and dysregulation of the reward system. However, existing research on non-invasive neuromodulation techniques for AUD has primarily focused on other brain regions, with limited exploration of interventions targeting the vmPFC. This study aims to evaluate the efficacy of a TUS intervention targeting the vmPFC through a randomized controlled trial, assessing its potential to reduce alcohol craving and prevent relapse, thereby providing a theoretical foundation for clinical translation.
- Being tested
- Shame TUS-vmPFC, Active TUS-vmPFC
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shame TUS-vmPFCDevice
The sham stimulation protocol maintained identical parameter settings to the active treatment group with equivalent application of ultrasound coupling gel at the left vmPFC site localized via the FP1 electrode. Crucially, the ultrasound transducer's output trigger was disabled during sham sessions, ensuring identical device operation procedures without acoustic energy delivery. Participants received daily 15-minute sham sessions matching the active group's 10-day treatment schedule.
Active TUS-vmPFCDevice
Participants in the active stimulation group will receive the transcranial ultrasound stimulation (TUS) targeted the left ventromededial prefrontal cortex (vmPFC), localized via the FP1 electrode position of the International 10-20 EEG system. The TUS will be delivered in the form of pulsed sinusoidal waves, with a fundamental frequency of 0.5 MHz and an intensity of 8 W/cm² (spatial peak pulse average intensity [Isppa]). The pulse duration will be 500 microseconds, and the sonication bursts will consist of 50 tone bursts per session, with a duty cycle of 5%. Each burst (pulse repetition frequency: 100 Hz) was followed by an 8-second inter-burst interval, yielding a total session duration of 15 minutes. Participants underwent one daily session for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The active group will receive active transcranial ultrasound stimulation. Receives: Device: Active TUS-vmPFC |
| Control group | Sham comparator | The sham group will receive shame transcranial ultrasound stimulation. Receives: Device: Shame TUS-vmPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of alcohol craving
Alcohol craving was assessed using the Visual Analog Scale (VAS; 0-10 points, higher scores indicating greater craving) during dual-condition olfactory exposure. Participants completed sequential 1.5-minute sniffing trials with alcohol cues and neutral stimuli (water), with the final craving score calculated as the alcohol-induced VAS score minus the neutral-state baseline.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of relapse behaviors with alcohol
Alcohol consumption and related behaviors were assessed using the Alcohol Use Disorders Identification Test (AUDIT,10 item). Each item is scored from 0 to 4 points, with higher scores indicating greater alcohol consumption.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of drinking symptom
Drinking symptom will be measured by Obsessive Compulsive Drinking Scale (OCDS), a 14-item scale assessing obsessive and compulsive drinking behaviors. Each item is scored from 0 to 4 points. The total score of OCDS ranged from 0 to 56.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Secondary outcomes (4)
The change of sleep
Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) rated by both patients and observers. The total score of PSQI ranged from 0 to 21, in which higher scores mean a lower level of sleep quality.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of depression
A provider administered questionnaire used to assess remission from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of anxiety
The HAMD-14 is a 14-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing anxiety severity.
Measured: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of self-control
The change of self-control will be measured by the stop-signal task and monetary incentive delay task.
Measured: baseline, immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion1 Jan 2027 (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.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Du, M.D, Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867224
- Sponsor's protocol ID
- JDu-014
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasound Stimulation as a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.
- ClinicalTrials.gov ID
- NCT06867224
- Acronym / sponsor ID
- JDu-014
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Mar 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 study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. Utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a sham treatment.
Detailed description
As a major global public health issue, the core therapeutic goal of alcohol use disorder (AUD) is to reduce alcohol craving and prevent relapse. In recent years, transcranial ultrasound stimulation (TUS) has emerged as a reliable non-invasive neuromodulation technique. Studies have shown that abnormalities in neural activity and structure in the ventromedial prefrontal cortex (vmPFC) of AUD are closely associated with alcohol craving and dysregulation of the reward system. However, existing research on non-invasive neuromodulation techniques for AUD has primarily focused on other brain regions, with limited exploration of interventions targeting the vmPFC. This study aims to evaluate the efficacy of a TUS intervention targeting the vmPFC through a randomized controlled trial, assessing its potential to reduce alcohol craving and prevent relapse, thereby providing a theoretical foundation for clinical translation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Active TUS-vmPFCThe active group will receive active transcranial ultrasound stimulation. |
| Control group | Sham comparator | Device: Shame TUS-vmPFCThe sham group will receive shame transcranial ultrasound stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not 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 (5 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 |
|---|---|---|
| Shame TUS-vmPFCThe sham stimulation protocol maintained identical parameter settings to the active treatment group with equivalent application of ultrasound coupling gel at the left vmPFC site localized via the FP1 electrode. Crucially, the ultrasound transducer's output trigger was disabled during sham sessions, ensuring identical device operation procedures without acoustic energy delivery. Participants received daily 15-minute sham sessions matching the active group's 10-day treatment schedule. | Device | Control group |
| Active TUS-vmPFCParticipants in the active stimulation group will receive the transcranial ultrasound stimulation (TUS) targeted the left ventromededial prefrontal cortex (vmPFC), localized via the FP1 electrode position of the International 10-20 EEG system. The TUS will be delivered in the form of pulsed sinusoidal waves, with a fundamental frequency of 0.5 MHz and an intensity of 8 W/cm² (spatial peak pulse average intensity [Isppa]). The pulse duration will be 500 microseconds, and the sonication bursts will consist of 50 tone bursts per session, with a duty cycle of 5%. Each burst (pulse repetition frequency: 100 Hz) was followed by an 8-second inter-burst interval, yielding a total session duration of 15 minutes. Participants underwent one daily session for 10 consecutive days. | Device | Intervention group |
Primary outcome
The change of alcohol craving
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Alcohol craving was assessed using the Visual Analog Scale (VAS; 0-10 points, higher scores indicating greater craving) during dual-condition olfactory exposure. Participants completed sequential 1.5-minute sniffing trials with alcohol cues and neutral stimuli (water), with the final craving score calculated as the alcohol-induced VAS score minus the neutral-state baseline.
The change of relapse behaviors with alcohol
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Alcohol consumption and related behaviors were assessed using the Alcohol Use Disorders Identification Test (AUDIT,10 item). Each item is scored from 0 to 4 points, with higher scores indicating greater alcohol consumption.
The change of drinking symptom
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
Drinking symptom will be measured by Obsessive Compulsive Drinking Scale (OCDS), a 14-item scale assessing obsessive and compulsive drinking behaviors. Each item is scored from 0 to 4 points. The total score of OCDS ranged from 0 to 56.
4 secondary outcomes
The change of sleep
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of depression
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of anxiety
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of self-control
Time frame: baseline, immediately after the 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 13 Jan 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. This study is not recruiting at the moment.
Jiang Du, M.D, Ph.D. principal investigator
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 Active TUS-vmPFC in people with Alcohol Use Disorder (AUD) and Transcranial Ultrasound Stimulation, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of alcohol craving (time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention). The study lists 3 primary outcomes in all. 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 13 Jan 2026.