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.
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;
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.
Parallel
Low-intensity focused ultrasound
Devicetranscranially deliver focal energy into the accumbens nucleus in the brain
false stimulus
Devicefalse stimulus
Substance craving intensity
Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
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.
Severity of Dependence
Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
Stimulant Relapse Risk
Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
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.
Executive function assessment
Using Behavior Rating Inventory of Executive Function (BRIEF) to assess how well executive function of participants is.
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.
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.
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