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Ultrasound zaps brain to fight addiction in tiny new trial

NCT ID NCT06474026

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This early study tests a device that uses focused ultrasound to target a brain region linked to addiction. Ten adults with stimulant use disorder will receive either a sham or real treatment. The goal is to see if it's safe and can help them stay drug-free for up to 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ExAblate 4000 Type 2.1 (focused ultrasound device)
What this could lead to
If it works, this could offer a new way to help people with stimulant addiction stay off drugs by reducing cravings.
What could go wrong
This is a very early feasibility study with only 10 people. It may not work, and the effects might not last. Risks of the brain procedure are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults between the ages of 19 and 60 2. Subject is diagnosed with a DSM-5 psychostimulant\* use disorder (PUD) by a board certified psychiatrist. \*Psychostimulants: Methamphetamine, cocaine, and other stimulants 3. Subject is currently receiving standard substance use disorder inpatient treatment or an intensive outpatient program 4. Subject has been off psychostimulants and other illicit drugs, confirmed via urine toxicology screen 5. Subject has not regularly used illegal drugs other than psychostimulants more than once a month in the past six months 6. The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements) 7. Subject is able to communicate sensations during the investigational procedure 8. Subject has made a voluntary decision to participate in this clinical trial and has given written consent. 9. Subject is willing to comply to the protocol Exclusion Criteria: 1. Subject with standard contraindication for MR imaging, such as non-MRI compatible implanted metallic devices. 2. Subject with known allergies to the MRI contrast agent gadolinium (Gadovist®) or contraindication (such as untreated hypokalemia). 3. Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours) 4. More than 30% of the skull area traversed by the sonication pathyway is covered by scars, scalp disorder (e.g., eczema), or atrophy of the scalp. 5. Subject with implanted objects in the skull or brain 6. Subject diagnosed with advanced kidney disease or on dialysis 7. Subjet with impaired renal function with estimated glomerular filtration rate less than 30 mL/min/1.73 m 2 8. Subject with known unstable cardiac status or severe hypertension including: * Documented myocardial infarction within six months of enrollment * Unstable angina on medication * Unstable or worsening congestive heart failure * Left ventricular ejection fraction (LVEF) below the lower limit of normal * History of hemodynamically unstable cardiac arrhythmias * Cardiac pacemaker * Severe hypertension (diastolic blood pressure over 100 on medication) 9. Subject has a history of abnormal bleeding or coagulopathy 10. Subject is receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure 11. Subject has blood coagulation test results outside the normal range * PLT\<100,000/μL * PT\>13.9 seconds or PTT\>37.5 seconds * INR\>1.2 12. Subject with cerebrovascular disease as determined by MRI according to Fazekas score 13. Subject with a past or current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced 14. Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline 15. Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB) 16. Subject with brain tumors 17. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other casues of reduced pulmonary vascular cross-sectional area. 18. Any known CNS infection or infection with the human immunodeficiency virus (HIV) 19. Subject who has had deep brain stimulation or a prior stereostatic ablation of the NAc, basal ganglia, or thalamus 20. Subject who has been administered botulinum toxins into to the arm, neck, or face for 5 months prior to baseline 21. Subject unwilling to refrain from using illicit drugs while participating in this clinical trial 22. Subject is pregnant or nursing women 23. For women of childbearing potential\*, who do not agree to use clinically appropriate contraception\*\* for the duration of the clinical trial \*Definition of women of childbearing age: means women who have experienced menarche, have not been surgically sterilized (hysterectomy or bilateral oophorectomy), or are not post-menopausal, defined as amenorrhea for 12 months or more for no other reason. \*\*Clinically appropriate contraception: defined as "\[intrauterine device (e.g., Loop, Mirena), chemical barrier method (spermicide), or subdermal implantable contraceptive device (e.g., Implanon)\] + physical barrier method (male or female)" for women, tubal surgery, or laparoscopic contraception (a type of tubal ligation). 24. Other, if the investigator determines that participation in the clinical trial is inappropriate ethically or because it may affect the outcome of the clinical trial

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seoul, 02841, South Korea