Opioid Use Disorder, SevereNCT07734623
Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
A study testing Low-intensity focused ultrasound and false stimulus in people with Opioid Use Disorder, Severe and Amphetamine Use Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the safety and efficacy of applying low-intensity focused ultrasound targeting the nucleus accumbens in individuals with opioid or amphetamine use disorders. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Opioid Use Disorder, Severe, Amphetamine Use Disorder
- What is being tested?
- Low-intensity focused ultrasound and false stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2030
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Chien Yi-Ling, +886 2-2312-3456 ext. #266013, ntuh.peers@gmail.com
About this study
The goal of this clinical trial is to investigate the safety and efficacy of applying low-intensity focused ultrasound targeting the nucleus accumbens in individuals with opioid or amphetamine use disorders. The main questions it aims to answer is:
- Low-intensity focused ultrasound targeting the nucleus accumbens demonstrates sufficient safety and predictable therapeutic efficacy in individuals with opioid or amphetamine use disorders.
Read more
Participants will:
- Received Low-intensity focused ultrasound neuromodulation once
- Visit the clinic for checkups and asessment at 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, 1.5 years, and 2 years after received Low-intensity focused ultrasound neuromodulation.
- Being tested
- Low-intensity focused ultrasound, false stimulus
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasoundDevice
transcranially deliver focal energy into the accumbens nucleus in the brain
false stimulusDevice
false stimulus
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Low-intensity focused ultrasound |
| Control group | Sham comparator | Not described Receives: Device: false stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance craving intensity
Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Urinalysis
Whether urine screening tests are positive for opioids and amphetamines. The intervention will be considered effective if the positivity rate decreases by 50% one month after the intervention compared with the time of intervention.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Severity of Dependence
Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Stimulant Relapse Risk
Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Secondary outcomes (9)
Mental health state
Using Patient Health Questionnaire (PHQ-9) to measure participants' mental health state, greater scores of these scales shows worse mental health state.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Executive function assessment
Using Behavior Rating Inventory of Executive Function (BRIEF) to assess how well executive function of participants is.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Neuropsychological function assessment
Using Cambridge Gambling Task (CGT) to assess Neuropsychological function since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Measured: Before intervention, three months, six months, a year, two year after treatment
functional Magnetic Resonance Imaging
Because the nucleus accumbens, the intervention target, may be involved in craving, functional magnetic resonance imaging (fMRI) will be used to assess changes in brain activation during the craving task before and after treatment.
Measured: Before intervention, 24hours, a month, three months after treatment
Positron Emission Tomography
Because neuromodulation may affect metabolic activity in the nucleus accumbens, positron emission tomography (PET) will be used to measure cerebral metabolism and compare changes before and after the intervention.
Measured: Before intervention, a month after treatment
Anxiety state
Using Hamilton Anxiety Rating Scale (HAM-A), and Generalized Anxiety Disorder questionnaire(GAD-7) to measure participants' anxiety state, greater scores of these scales shows worse anxiety state.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Depression state
Using Hamilton Depression Rating Scale (HAM-D), to measure participants' mental health state, greater scores of these scales shows worse depression state.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Attendtion state
Using Adult ADHD Self-Report Scale (ASRS) to assess how well attention state of participants is.
Measured: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Working memory capacity
Using N-back test to assess working memory capacity since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Measured: Before intervention, three months, six months, a year, two year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use Disorder, SevereStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734623
- Sponsor's protocol ID
- 202404026DINC
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
- ClinicalTrials.gov ID
- NCT07734623
- Acronym / sponsor ID
- 202404026DINC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to investigate the safety and efficacy of applying low-intensity focused ultrasound targeting the nucleus accumbens in individuals with opioid or amphetamine use disorders. The main questions it aims to answer is:
- Low-intensity focused ultrasound targeting the nucleus accumbens demonstrates sufficient safety and predictable therapeutic efficacy in individuals with opioid or amphetamine use disorders.
Participants will:
- Received Low-intensity focused ultrasound neuromodulation once
- Visit the clinic for checkups and asessment at 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, 1.5 years, and 2 years after received Low-intensity focused ultrasound neuromodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Low-intensity focused ultrasound |
| Control group | Sham comparator | Device: false stimulus |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Low-intensity focused ultrasoundtranscranially deliver focal energy into the accumbens nucleus in the brain | Device | Experimental group |
| false stimulusfalse stimulus | Device | Control group |
Primary outcome
Substance craving intensity
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
Urinalysis
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Whether urine screening tests are positive for opioids and amphetamines. The intervention will be considered effective if the positivity rate decreases by 50% one month after the intervention compared with the time of intervention.
Severity of Dependence
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
Stimulant Relapse Risk
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
9 secondary outcomes
Mental health state
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Executive function assessment
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Neuropsychological function assessment
Time frame: Before intervention, three months, six months, a year, two year after treatment
functional Magnetic Resonance Imaging
Time frame: Before intervention, 24hours, a month, three months after treatment
Positron Emission Tomography
Time frame: Before intervention, a month after treatment
Anxiety state
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Depression state
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Attendtion state
Time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Working memory capacity
Time frame: Before intervention, three months, six months, a year, two year 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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 Low-intensity focused ultrasound and false stimulus in people with Opioid Use Disorder, Severe and Amphetamine Use Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 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 31 Jul 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 Taiwan. 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 Chien Yi-Ling (+886 2-2312-3456 ext. #266013, ntuh.peers@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance craving intensity (time frame: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment). The study lists 4 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 31 Jul 2026.