Clinical trial Recruiting at 1 site Interventional Ages 20 to 50

Low-Intensity Focused Ultrasound for Severe Opioid or Amphetamine Use Disorder

Official title: Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness

Run by National Taiwan University Hospital · NCT07734623 · Data updated 2026-11-12

This study tests whether a single session of low-intensity focused ultrasound to the nucleus accumbens is tolerable and may help treat people with severe opioid or amphetamine use disorders.

Quick facts

Study typeInterventional
Ages20 Years to 50 Years
SexAll
Enrollment60 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedJuly 31, 2026
Trial IDNCT07734623 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with severe opioid use disorder or severe amphetamine use disorder who are on stable medication-assisted treatment and able to comply with study visits.

Probably not a fit

Individuals for whom the ultrasound does not produce safety or clinical benefit, or those who do not complete follow-up assessments, may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial investigates the safety and potential effectiveness of applying low-intensity focused ultrasound to the nucleus accumbens in adults with severe opioid or amphetamine use disorder. Participants receive one neuromodulation session and return for follow-up visits at multiple intervals up to two years to monitor safety and therapeutic effects. Eligibility requires a confirmed diagnosis, stable medication treatment, recent abstinence from illicit drugs, MRI-identifiable targets, and ability to participate in study procedures. The trial is led by National Taiwan University Hospital, with the aim of determining tolerability and whether this approach yields predictable benefits for this population.

Why it matters

Potential benefit: If successful, the approach could offer a new neuromodulation option that may reduce craving or relapse risk in severe opioid or amphetamine use disorder.

How similar studies have gone: Previous similar neuromodulation approaches have shown safety in other settings, but this exact nucleus accumbens ultrasound method is exploratory for substance use disorders.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Meets the DSM-5 criteria for opioid use disorder or amphetamine use disorder, with a severity level of severe, and does not currently meet the criteria for in sustained remission;
* Within 7 days prior to the screening assessment, the participant must have been receiving a stable dose of medication treatment, such as methadone, buprenorphine/naloxone, or naltrexone;
* Within 7 days prior to the screening assessment, the participant must have abstained from illicit substances and alcohol, and must have a negative urine drug test;
* The bilateral nucleus accumbens must be clearly identifiable on magnetic resonance imaging (MRI), such that they are sufficient for treatment targeting and for indirect measurement from other anatomical structures;
* The participant must be able to communicate effectively and express their feelings and experiences during the study procedures;
* The participant must be willing to comply with the study requirements, including adherence to prescribed medications and cooperation with study visits and assessments.

(The participant must have the capacity to make independent medical decisions, as determined by the clinical team.)

Exclusion Criteria:

* Presence of neurological disorders or major psychiatric disorders, such as acute-phase schizophrenia spectrum disorder, acute-phase bipolar disorder, acute-phase major depressive disorder, severe cognitive impairment, or recent suicidal ideation or plan;
* Antisocial personality disorder;
* Occurrence of major physical health problems within 6 months prior to the trial, including: Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmia, tachycardia or bradycardia (\>100 bpm or \<60 bpm), abnormal systolic blood pressure (\>180 mmHg or \<90 mmHg), or abnormal diastolic blood pressure (\>180 mmHg); Platelet or coagulation abnormalities (INR \> 1.5) or current use of medications that may cause anticoagulation, such as warfarin or Avastin; Renal dysfunction (eGFR \< 30 mL/min/1.73 m²) or ongoing hemodialysis; Severe infection; Immunocompromised status; History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within the past 6 months, or brain tumor; Neurological diseases, such as stroke, epilepsy, Parkinson's disease, dementia, or related disorders; Any other physical illness that, based on clinical evaluation, may pose a significant risk to physical function or life during treatment.
* Participants who, upon evaluation, are deemed unsuitable for MR-guided focused ultrasound treatment, including those with a low skull density ratio (\<0.4), intracranial implants, or energy-absorbing structures or sensitive tissues along the ultrasound beam path that cannot be avoided (such as prior ventriculoperitoneal shunt sites, surgical metal clips, significant calcifications, extensive scarring, or any rigid implants). During the pre-treatment evaluation, a head CT scan will be performed to determine whether the skull density ratio is suitable for focused ultrasound treatment. Based on prior theoretical evidence, an excessively low skull density ratio may reduce the efficiency of MR-guided focused ultrasound and increase the risk of adverse effects, and therefore such participants are considered unsuitable for focused ultrasound treatment.
* Structural abnormality of either side of the nucleus accumbens;
* Contraindications to MRI, such as claustrophobia, allergy to MRI contrast agents, or the presence of metallic implants incompatible with MRI;
* Contraindications to PET imaging, such as allergy to radiopharmaceutical contrast agents;
* Inability to comply with trial-related instructions, lack of legal/behavioral capacity, or lack of motivation to receive treatment;
* Pregnancy or breastfeeding;
* Scalp atrophy or poor wound healing of the scalp;
* Any other condition that, in the physician's judgment, makes the participant unsuitable for enrollment in the clinical trial.

Where it's running

  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.